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The Graphic Designer is responsible for executing high-quality packaging, print, and digital design initiatives that support Overseas Food Trading’s expanding global product portfolio. This role combines creative development with technical production expertise to ensure visually compelling, production-ready materials that align with brand standards, regulatory requirements, and commercial objectives. The position supports cross-functional departments, including Sales, Marketing, Product Development, Compliance, and Logistics, ensuring that all creative assets are delivered accurately, efficiently, and within established timelines. The Graphic Designer plays a key role in maintaining brand consistency, supporting product launches, and contributing to the company’s continued growth in both retail and foodservice sectors. This role requires effective collaboration with internal stakeholders and external print vendors. The individual must be comfortable working in a fast-paced environment where priorities may shift and must respond with flexibility, professionalism, and structured follow-through. ESSENTIAL JOB FUNCTIONS Creative Development & Design Execution • Develop compelling packaging, product labels, marketing collateral, and digital assets that effectively showcase the company’s global product portfolio., • Execute design projects from initial concept through final production, ensuring alignment with brand standards and commercial objectives., • Translate product positioning and sales strategies into visually engaging creative solutions., • Maintain consistency across multiple brands while adapting designs to category-specific requirements., • Contribute creative ideas during team brainstorming sessions and design reviews while remaining receptive to direction and feedback. Packaging Production & Technical File Preparation • Prepare production-ready artwork files in accordance with printer specifications, dielines, and regulatory labeling requirements., • Ensure proper setup of bleeds, color profiles, trapping, typography, and layout accuracy for print production., • Create accurate mockups and renderings for internal review, sales presentations, and customer approvals., • Coordinate proof reviews and revisions to maintain quality control prior to final release., • Communicate directly with print vendors and external production partners to confirm technical specifications and production timelines. Project Management & Workflow Coordination • Manage multiple concurrent projects while maintaining high standards of quality and meeting established deadlines., • Proactively prioritize workload based on shifting business needs and launch timelines., • Support Senior Graphic Designer and team members during peak periods to ensure departmental efficiency., • Maintain organized digital file structures, version control, and archived assets for long-term accessibility., • Track project progress and follow through to completion with structured organization and accountability. Cross-Functional Collaboration • Collaborate closely with Sales, Marketing, Product Development, and Compliance to ensure design solutions align with regulatory standards and commercial objectives., • Incorporate stakeholder feedback efficiently while maintaining design integrity and visual clarity., • Support product launches by ensuring all creative materials are completed accurately and delivered on schedule., • Assist in resolving design-related production issues through clear communication and solution-oriented problem solving. Continuous Improvement & Brand Support • Stay current with packaging trends, print technologies, and food industry design standards., • Identify opportunities to enhance workflow efficiency and creative processes within the Design Department., • Contribute to the ongoing elevation of brand presentation across retail and foodservice channels. PERFORMANCE EXPECTATIONS • Demonstrate strong ownership and accountability for assigned design projects from concept through production release., • Consistently deliver high-quality, production-ready artwork that meets brand standards, regulatory requirements, and technical specifications., • Maintain accuracy and attention to detail, minimizing revisions caused by preventable errors., • Effectively manage multiple concurrent projects while meeting established deadlines in a fast-paced environment., • Exhibit professionalism and flexibility when priorities shift or urgent requests arise., • Maintain organized digital file systems and documentation to support team efficiency and long-term asset management., • Communicate clearly and collaborate effectively with internal departments and external vendors., • Contribute positively to team morale by supporting colleagues during high-volume periods and participating constructively in feedback sessions., • Demonstrate initiative in identifying workflow improvements and creative enhancements. Education and Experience: • Bachelor’s degree in Graphic Design or related field required., • A minimum of 3 years of professional graphic design experience, preferably in packaging, print production, or food/CPG industries., • Demonstrated experience preparing production-ready artwork files for commercial print., • Experience collaborating cross-functionally within a structured business environment preferred. Knowledge and Skill Requirements/Specialized Courses and/or Training: • Strong foundation in design principles including layout, typography, color theory, and visual hierarchy., • Advanced proficiency in Adobe Creative Suite (Illustrator, Photoshop, InDesign, Acrobat)., • Advanced Photoshop capabilities, including photo manipulation, retouching, and product renderings., • Solid understanding of packaging mechanics, dielines, labeling requirements, and print production processes., • Knowledge of color management, prepress preparation, and technical file setup for commercial printing., • Ability to manage multiple projects and shifting priorities with structured organization and attention to detail., • Strong problem-solving skills with the ability to troubleshoot production-related issues., • Working knowledge of FDA labeling standards or food packaging compliance requirements is a plus. Language and Communication Skills: • Strong written, verbal, and interpersonal communication skills., • Ability to clearly articulate design concepts, creative rationale, and technical requirements to internal stakeholders and external vendors., • Effective collaboration with cross-functional departments including Sales, Marketing, Product Development, Compliance, and Logistics., • Ability to interpret and incorporate feedback efficiently while maintaining professionalism and design integrity., • Clear and professional communication when coordinating with print vendors regarding specifications, proofs, revisions, and production timelines., • Strong listening skills and openness to constructive critique in a collaborative team environment. Physical, sensory, and motor demands: Frequent standing and sitting. Intermittent squatting, bending, twisting, lifting. This position requires excellent visual acuity and auditory sense. The noise level in the work environment is usually quiet.

About Wakefern Wakefern Food Corp. is the largest retailer-owned cooperative in the United States and supports its co-operative members' retail operations, trading under the ShopRite®, Price Rite®, The Fresh Grocer®, Dearborn Markets®, Fairway Markets®, Gourmet Garage®, and Morton Williams® banners. Employing an innovative approach to wholesale business services, Wakefern focuses on helping the independent retailer compete in a big business world. Providing the tools entrepreneurs need to stay a step ahead of the competition, Wakefern’s co-operative members benefit from the company’s extensive portfolio of services, including innovative technology, private label development, and best in class procurement practices. The Quality Assurance Supplier Compliance Auditor is responsible for managing compliance programs for Wakefern Own Brands suppliers. This role develops and maintains an approved supplier program based on regulatory and corporate requirements to mitigate risk and ensure Wakefern and its Members source from vendors that meet established standards. The position focuses on ensuring food safety and quality expectations are met through on-site supplier audits, documentation reviews, and corrective action management. Responsibilities include investigating consumer complaints and recalls/withdrawals, coordinating with internal teams, and supporting the supplier selection processes. Strong knowledge of FDA, USDA, GFSI standards, HACCP, GMPs, SOPs, and third-party certifications (GLOBAL G.A.P, PrimusGFS, BRC, and SQF) is essential. Essential Functions • Reviews and maintains supplier documentation and audit results within the Supplier Management program., • Actively participates in supplier quality related communication and feedback. This includes ownership of the escalation process for nonconforming product, ensuring root cause analysis and corrective solutions are identified and implemented with closure plans., • Participates in supplier selection process for food safety and quality., • Follows-Up on consumer complaints/recalls/withdrawals related to private label product, regulatory issues and coordinates with the Consumer Affairs divisions with appropriate action., • Schedules and confirms audit date with the Supplier., • Prepares and sends supplier audit plan according to protocols., • Adheres to all quality and code of conduct standards., • Conducts audits using applicable checklists, reports, and tools available., • Maintains positive Supplier relationships and responds to all Supplier inquiries and concerns., • Submits complete and accurate audit reports within established timelines to Manager., • Ensures thorough Supplier records are maintained., • Handles multiple projects/tasks simultaneously and within required time schedules., • Maintains up to date knowledge of applicable compliance regulations and standards. Qualifications • Bachelor’s degree in Food Science preferred or similar Science degree., • Seven (7) years of experience in QA/QC processes in a food and/or regulatory industry., • Demonstrated knowledge in FDA and USDA regulations in all related commodities including Seafood., • Demonstrated knowledge in conducting risk assessments, audits, Food GMPs, SOPs, HACCP/Food Safety and environmental guidelines., • Demonstrated Knowledge in the Global Food Safety Initiative (GFSI) Auditing Scheme highly preferred., • SQF Practitioner and/or SQF Internal Auditor Certification highly preferred., • Accredited minimum 16 hour HACCP training., • Self-motivated and strong analytical / problem solving skills., • Experience working in cross-functional teams with significant experience in auditing products, operations and processes are key qualifications of this position., • Familiarity with the third-party certification process (GLOBAL G.A.P, PrimusGFS, Harmonized GAP, Primus Standard, BRC and SQF)., • Effective communication and customer service skills., • Well-developed organizational and time management skills., • Strong computer skills, including Excel, Word, Outlook, and Database systems., • Required to travel up to 80%, mostly overnight travel throughout the U.S. and possibly international., • Spanish verbal proficiency, preferred: must be able to conduct field interviews with agricultural workers, address hygiene practices, and discuss basic agricultural topics including harvesting procedures, chemical handling and personal protective equipment use. Working Conditions & Physical Demands • This position is primarily field‑based (approximately 80%) with remaining time spent performing administrative and computer‑based work (approximately 20%). The position requires regular travel to audit sites by car and/or plane. The incumbent must be able to communicate effectively in person and by phone. Travel and fieldwork involve the ability to stand, walk, and carry up to 25 pounds of equipment, including navigating uneven or steep terrain as needed., • While auditing/assessing, • Open agricultural fields and orchards; food and non-food handling and storage facilities, • Moving tractors, farm machinery as well as standard processing and packing equipment, • Temperature extremes of high heat or cold Core Competencies • Communicate Effectively: Communicates thoughts and ideas in a well-organized manner, encouraging two-way communication., • Build Relationships: Creates cross-functional partnerships through the development and maintenance of constructive and cooperative relationships., • Stay Competitive: Demonstrates a mindset of continuous improvement while exhibiting passion and enthusiasm for their work., • Embrace Change: Looks for new ways of working by supporting advancements in processes and technology., • Develop You: Identifies and capitalizes on opportunities for personal and professional career growth., • Drive for Results: Supports divisional and strategic objectives through achievement of work goals. Compensation and Benefits The salary range for this position is $81,000 to $105,000. Placement in the range depends on several factors, including experience, skills, education, geography, and budget considerations. Wakefern is proud to offer a comprehensive benefits package designed to support the health, well-being, and professional development of our Associates. Benefits include medical, dental, and vision coverage, life and disability insurance, a 401(k) retirement plan with company match & annual company contribution, paid time off, holidays, and parental leave. Associates also enjoy access to wellness and family support programs, fitness reimbursement, educational and training opportunities through our corporate university, and a collaborative, team-oriented work environment. Many of these benefits are fully or partially funded by the company, with some subject to eligibility requirements.

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Program Lead, Digital Informatics QMS Strategy. This Program Lead is responsible for developing, maintaining, and communicating QuidelOrtho' s Quality Management System strategy for Digital Informatics, Software as a Medical Device (SaMD), Artificial Intelligence (AI/ML), and Automation platforms as they pertain to in vitro diagnostic (IVD) products and associated services across all global markets. This role serves as the strategic quality authority for digitalenabled products, ensuring that regulatory, quality, and compliance expectations are proactively embedded into product lifecycle processes, digital delivery models, and organizational ways of working. This position will be onsite in Rochester, NY. * Define and evolve the global QMS strategy for digital health technologies, including SaMD, AI/MLenabled systems, cloudbased platforms, and automated workflows. * Interpret and operationalize global regulatory and standards requirements (e.g., FDA, EU MDR/IVDR, ISO 13485, IEC 62304, ISO 62366, ISO 14971, GxP data integrity) as they apply to digital and informatics solutions. * Partner with R&D, IT, Product Management, Regulatory Affairs, PMO, and Technical Quality to ensure quality by design is embedded throughout the digital product lifecycle. * Establish governance models, procedural frameworks, and decision pathways that enable agile and scalable digital innovation while maintaining regulatory compliance. * Lead riskbased approaches for software lifecycle management, cybersecurity, data governance, AI/ML change control, and algorithm performance monitoring. * Serve as a thought leader and internal consultant on emerging regulatory expectations related to AI/ML, realworld data, automation, and digital transformation. * Perform other work-related duties as assigned. Required: * Bachelors and/or technical degree in Life Sciences, Pharmacy, Engineering, Computer Science, Biomedical Engineering or a related technical discipline. * 8-10 years of progressively responsible experience within a regulated Quality Management System environment, with significant exposure to software, digital health, or informatics solutions. * Demonstrated ability to lead QMS strategy development and influence senior stakeholders across complex, matrixed organizations. * Strong understanding of global regulatory frameworks applicable to digital health, SaMD, AI/ML, and automated systems. * Proven experience applying risk management, design controls, software lifecycle processes, and post market surveillance to digital products. * Ability to translate regulatory and quality requirements into practical, scalable processes that support innovation. * Bias toward action, with a track record of driving execution aligned to organizational strategy. * Excellent written and verbal communication skills, including the ability to represent quality positions to executive leadership. * Strong collaboration skills and the ability to operate effectively across technical, regulatory, and business functions. * Willingness and ability to travel approximately 10-15%. Preferred: * Advanced degree (MS, PhD, or PharmD) strongly preferred. * Experience with AI/ML governance, algorithm change management, or real-world performance monitoring. * Background in cloudbased systems, cybersecurity, data integrity, or regulated automation platforms. * Experience supporting global regulatory inspections involving software or digital health products. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. No strenuous physical activity. Standard activities include sitting, standing, walking, talking, hearing, and visual work. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: * Thrive Together - Collaborate intentionally, grow as a team * Make It Happen - Focus on priorities, embrace continuous improvement * Commit to Service - Cultivate a service mindset * Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $155,000 to $202,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-SP1

Position: Manufacturing Associate Duration: 06 Months Location: Summit West, NJ, 07901 Pay Range: $ 25 - 25.76/hr Description: Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. • Required Competencies: Knowledge/ Skills, and Abilities:, • Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique, • Knowledge of cGMP/FDA regulated industry, • Basic mathematical skills - General understanding of cGMPs, • Technical writing capability, • Proficient in MS Office applications, • Background to include an understanding of biology, chemistry, medical or clinical practices Pre-requisites: Entry- Level, • Duties and Responsibilities:, • Production of blood component lots through cell culture, harvest, and cryopreservation., • Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum., • Weighs and measures in-process materials to ensure proper quantities are added/removed., • Adheres to the production schedule ensuring on-time, internal production logistics., • Records production data and information in a clear, concise, format according to proper GDPs., • Works in a team based, cross-functional environment to complete production tasks required by shift schedule., • Motivated, team consciousness individuals are needed to fulfill job requirements., • Leads a team within a designated function of manufacturing, however, supervision will be managed by the shift Supervisor., • No direct reports will be assigned to this job role., • Performs other tasks as assigned. Important Notes about working in the clean room: This position takes place in a GMP clean room environment, which includes being gowned for up to 6 hours. During the processing time in the clean room, no breaks may be taken Working Conditions: • Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. - Physical dexterity sufficient to use computers and documentation., • Sufficient vision and hearing capability to work in job environment., • Ability to lift up to 25 pounds., • Must have the ability to work around laboratories and controlled, enclosed, restricted areas., • Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet., • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas., • Flexibility to don clean room garments and personal protective equipment (PPE)., • Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected., • Routine exposure to human blood components., • Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.

We are looking to add a Senior Clinical Research Coordinator to a growing team with lots of room for growth. This is a full time, permanent onsite position that comes with full benefits, PTO etc. Relocation or Sponsorship will not be offered at this time. Position Summary The Senior Clinical Research Coordinator (SCRC) is responsible for the planning, coordination, and execution of clinical research studies in compliance with regulatory requirements, institutional policies, and study protocols. This role provides advanced coordination of multiple clinical trials, ensures high-quality data collection, supports regulatory submissions, and may mentor junior research staff. Key Responsibilities • Coordinate and manage all aspects of assigned clinical trials from start-up through closeout., • Ensure study conduct follows protocol, Good Clinical Practice (GCP), and regulatory guidelines., • Schedule and oversee study visits, procedures, and participant follow-up., • Maintain study timelines, enrollment targets, and protocol compliance., • Prepare and submit regulatory documents to Institutional Review Boards (IRB), sponsors, and regulatory agencies., • Maintain regulatory binders and essential study documentation., • Ensure adherence to FDA, ICH-GCP, and institutional requirements., • Screen, recruit, and consent study participants., • Educate participants about study procedures, risks, and benefits., • Monitor participant safety and report adverse events according to protocol., • Collect, review, and enter clinical trial data into electronic data capture systems (EDC)., • Resolve data queries and ensure accuracy and completeness of study records., • Maintain source documentation and case report forms (CRFs)., • Serve as primary contact for sponsor and CRO monitors., • Prepare for site visits, monitoring visits, and audits., • Address findings and implement corrective actions when needed., • Provide training and guidance to junior clinical research coordinators and support staff., • Assist with study feasibility assessments and site start-up activities., • Contribute to process improvements and research program development. Education • Bachelor’s degree in Life Sciences, Nursing, Public Health, or related field required, • Master’s degree preferred Experience • 4–7+ years of clinical research coordination experience, • Experience managing multiple clinical trials preferred, • Experience with regulatory submissions and monitoring visits Certifications (Preferred) • CCRC (Certified Clinical Research Coordinator) – ACRP, • CCRP (Certified Clinical Research Professional) – SoCRA Skills & Competencies • Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes, • Excellent organizational and project management skills, • Strong attention to detail and documentation practices, • Ability to manage multiple studies simultaneously, • Effective communication and interpersonal skills, • Proficiency in EDC systems, CTMS, and Microsoft Office

Job Title: QC Associate Scientist, Microbiology Location: Summit, NJ 07901 Assignment Duration: 06 months QC Associate Scientist, Microbiology (Sunday - Wed, 4pm -230am) Pay Range: $ 37-39/hr POSITION SUMMARY This position will work both independently and with the team to perform routine and non-routine microbiological testing, microbiology laboratory maintenance functions and Environmental Monitoring functions where necessary. PRIMARY DUTIES/RESPONSIBILITIES • Carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws., • Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times., • Follow directions properly, work cooperatively as an individual contributor and as a team member., • Communicate effectively with QC peers, cross-functional peers and management., • Assist in troubleshooting and solving problems that may come up in the day to day operation of the department., • Participate in aseptic process qualifications, such as aseptic gowning and media fill reads., • Perform Bacterial Endotoxin and Sterility Testing., • Perform microbial identification via polymerase chain reaction (PCR)., • Perform growth promotion testing of microbiological media., • Perform mycoplasma testing via PCR., • Perform Environmental Monitoring on routine basis., • Perform microbial isolation techniques and perform Gram stain identifications., • Send out samples to contract labs and track results/reports., • Evaluate environmental/personnel monitoring samples and create NOEs for action levels., • Performs general laboratory cleaning/wipe-down., • Perform routine maintenance of lab equipments., • Under the guidance of management, support special project work., • Document laboratory test results on worksheets, forms and logbooks utilizing Good Documentation Practices., • Maintain lab inventory and order lab supplies and materials., • Receives and stock test reagents, lab supplies and test media., • Support continuous improvement projects related to QC, • Author and revise controlled documents such as Standard Operating Procedures and Controlled Forms. Author non-routine Protocols/Validation Plans/ reports in support of projects., • Assist with investigations &CAPAs associated with Microbiological testing., • Support data trending and tracking of results., • Perform all other duties as assigned. EDUCATION/EXPERIENCE REQUIREMENTS • Requires Bachelor’s degree in Microbiology, Molecular Biology, or related discipline and minimum 3 years of experience working in a regulated manufacturing environment. Microbiology lab experience & Master’s Degree strongly preferred. An equivalent combination of experience/education is acceptable., • Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements., • Good knowledge of Microsoft Word and Excel., • Responds to challenges and additional projects in an understanding, positive, and objective manner., • Adaptable to dynamic conditions, work practices, and project timelines., • Ability to multitask, prioritize workload and interpret data accurately., • Able to communicate effectively with GDPO functional areas and external agencies., • Fosters teamwork and promotes an environment that motivates others to achieve our goals. Working Conditions • The incumbent will be required to wear uniform/ PPE to work in the manufacturing or laboratory environment. • The incumbent may be required to stand and walk for extended amount of time., • The incumbent may be required to work hazardous materials., • Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an absolute must., • Change to work timings and assigned tasks may occur at a very short notice to support business needs., • Shift schedule could include 4 days including weekends.

The Food Scientist I reports directly to the Product Development & Commercialization Lead and is responsible for translating validated technical platforms into scalable, launch-ready commercial products within the snack and confectionery portfolio. This role focuses on formula finalization, scale-up execution, supplier coordination, and commercialization readiness. The position plays a critical role in ensuring products move efficiently from development to successful market launch while meeting performance, quality, and compliance requirements. The Food Scientist I operates within the Product Development & Commercialization Team and works cross-functionally with Technical & Research, QA, Operations, Procurement, Engineering and external suppliers. Key Responsibilities: 1. Formula Finalization & Optimization · Refine and finalize product formulations for commercial readiness. · Optimize formulas for manufacturability, cost targets, and sensory performance. · Align bench, pilot, and production formulations. · Maintain master formulas in designated systems (e.g., SpecRight). · Ensure formula accuracy aligning with NFP and artwork. 2. Pre-Launch Analytical Validation · Coordinate and verify required analytical testing prior to commercialization. · Establish internal product quality standards (texture, moisture range, sensory benchmarks). · Review analytical data to confirm product consistency and compliance with specification limits. · Ensure discrepancies between formula and analytical output are resolved prior to launch. · Support validation of NFP calculations through correct formula alignment. 3. Pre-Launch Compliance & Regulatory Validation · Ensure formula used for NFP matches production activities with allowed variations. · Confirm documentation required for audit and regulatory review is complete before launch. · Proactively identify compliance risks during development phase before artwork is finalized. 4. Scale-Up & Commercial Trials · Plan and execute pilot and commercial production trials. · Define and validate critical process parameters in collaboration with Operations. · Troubleshoot production challenges (texture variation, moisture migration, ingredient interactions). · Document trial outcomes and quality information. 5. Launch Execution & Cross-Functional Coordination · Coordinate cross-functional launch readiness activities. · Ensure all documentation (formula, specification, analytical validation, compliance review) is complete prior to commercialization. · Partner with QA Compliance for final label approval. · Participate in sprint reviews and escalation discussions led by the Project Manager. 6. Portfolio Management & Continuous Improvement · Support cost optimization and formula renovation initiatives. · Investigate product performance complaints (staleness, hardness, sensory deviation). · Implement corrective actions to maintain product quality and brand integrity. Qualifications: Master’s degree in Food Science, Food Engineering, or related field. 1–3+ years of experience in snack and/or confectionery product development. Experience supporting pilot and commercial production. Working knowledge of: Water activity & moisture control; Texture analysis; Nutrition labeling fundamentals; Basic FDA labeling and compliance requirements

Responsible for receipt and documentation of Safety information for Marketed and Investigational Products. Interacts with health professionals and consumers to obtain and follow-up reports of possible adverse events with company products. Provides product information to health care professionals, consumers, and sales representatives. Codes and enters information into the global safety database. Verifies the accuracy, completeness and validity of information for each adverse event report for which he/she is responsible. Assures consistency of case records and documentation. Creates and ensures distribution of regulatory reports for FDA and other regulatory health authorities. Accurate and timely data entry of both domestic and foreign adverse event and serious adverse event information into the PSSS (Product Safety Surveillance System) consistent with the ARISg coding manual, SOPs/WIDs, process flows and established time frames within the ARISg workflow. Full understanding of the products’ company Core Data sheet, PI, and/or IB for accurate labeling and listedness. Perform appropriate and timely follow-up per department guidelines, including accurate and thorough communication documentation within the case. Maintain proficiency in the utilization of the PSSS, including MedDRA coding. This may include participating in the validation process for the PSSS. Ensure accurate and timely submissions to regulators, co-marketing partners and affiliates within company and regulatory timeframes. Utilize ARISg for all reporting and confirmation of successful distribution and acknowledgement. Maintain sufficient knowledge of all company products to ensure professional and knowledgeable discussions with consumers and healthcare providers and dissemination of accurate product information in response to queries. Provide high level customer service to consumers, health care professionals and internal customers. Complete all required training within the timelines provided so as to ensure knowledge of all relevant corporate and departmental SOP’s, SWP’s and WID’s. Ensure timeliness in regulatory compliance Gather sufficient information to assess the medical significance of an adverse event report, while at the same time assuring the information provided adequately addresses the concerns of the health care provider and/or consumer. Required Qualification & Skills: Bachelor’s degree in Medical field with RN or RPh licensure, or PharmD/MD degree required. Minimum 2 to 4 years in industry application of clinical medicine/pharmacy with a minimum of 1 year in pharmaceutical drug safety Experience in verbally interviewing and/or providing medical information to health care professionals and consumers Application of clinical medicine to patient care Medical terminology and standards of patient care Computer proficiency

Mama’s Creations, Inc. (NASDAQ: MAMA) is a leading marketer and manufacturer of fresh deli prepared foods, found in over 8,500 grocery, mass, club and convenience stores nationally. The Company’s broad product portfolio, born as MamaMancini’s, from a rich history in Italian foods, now consists of a variety of high quality, fresh, clean and easy to prepare foods to address the needs of both our consumers and retailers. Our vision is to become a one-stop-shop deli solutions platform, leveraging vertical integration and a diverse family of brands to offer a wide array of prepared foods to meet the changing demands of the modern consumer. For more information, please visit . We have an excellent opportunity for a highly skilled and experienced leader to serve as the Senior Director, Plant Operations of our East Rutherford facility. You will be the senior site leader responsible for the overall performance, safety, Grandma Quality, controls, culture, and financial results of the manufacturing facility. This role serves as the plant’s general manager, accountable for translating enterprise strategy into consistent, disciplined execution with excellence at the site level. The Senior Director leads through people, systems, and standards, ensuring production, FSQA, maintenance, warehousing, and workforce leadership operate in alignment with Grandma Quality. This role balances results with responsibility, honoring Mama’s heritage while building scalable, sustainable operations. Key Responsibilities • Own end-to-end plant performance, including safety, food safety, quality, service, cost, labor efficiency, and employee engagement., • Own overall plant efficiency and throughput performance, ensuring production capacity, labor models, and operating practices support enterprise targets., • Drive improvement in throughput, yield, and line performance by setting expectations, removing barriers, and holding leaders accountable for results., • Serve as the strategic leader for the site, translating enterprise priorities into clear site-level strategies, initiatives, and execution plans., • Partner with the Senior Manager, Production Operations to ensure production schedules and execution plans support optimal efficiency and service outcomes., • Own the plant operating budget, including labor, overtime, supplies, and controllable costs; ensure performance aligns with financial targets., • Balance cost discipline with Mama’s commitment to Grandma Quality, safety, and employee well-being., • Use KPIs and financial data to evaluate performance, prioritize investments, and guide decision-making., • Partner with OpEx/CI to identify and sponsor continuous improvement initiatives that deliver measurable, sustainable gains in efficiency, throughput, and cost performance., • Ensure efficiency gains and cost improvements are sustainable and embedded into standard work and leadership routines., • Lead, coach, and hold accountable all direct reports, site functional leaders, and the downline., • Serve as the primary owner of plant culture, reinforcing values-based leadership, respectful supervision, and consistent accountability., • Ensure site execution aligns with enterprise standards of excellence and Grandma Quality while addressing location-specific risks and opportunities., • Partner with FSQA leadership to maintain strong food safety culture, regulatory compliance, and audit readiness., • Own site-level labor strategy, workforce planning, and performance management in partnership with People Operations., • Drive operational discipline through KPIs, operating practices, and structured problem-solving., • Partner with Reliability & Asset Management to support uptime, preventive maintenance execution, and capital improvements., • Support capital projects, expansions, and equipment installations at the site level., • Participate in operational diligence and integration activities related to acquisitions or expansions impacting the facility., • Serve as the primary escalation point for site risks, performance gaps, and employee relations matters., • Build strong cross-functional relationships that nurture trust, accountability, and pride in workmanship., • Collaborate closely with Senior Directors and plant leaders at other facilities to share best practices, standardize where appropriate, and drive enterprise-wide operational improvement., • Participate in cross-facility working groups, initiatives, and problem-solving efforts to strengthen consistency, performance, and scalability across the enterprise., • Champion collaboration between facilities while respecting site-specific strengths, constraints, and heritage., • Other related tasks, as necessary to drive results and support the business. Qualifications • Bachelor’s degree in Operations Management, Engineering, Business, or related field; or equivalent experience., • 15+ years of progressive leadership experience in manufacturing operations, preferably in food manufacturing or regulated environments., • 10+ years of experience leading multi-shift operations and managing leaders (managers/supervisors)., • Demonstrated experience owning site KPIs, budgets, labor planning, and operational performance improvement., • Expert usage of ERP systems. NetSuite preferred., • Strong working knowledge of food safety/regulatory environments (USDA/FDA), HACCP, GMPs, and audit readiness expectations., • Proven ability to lead through change while maintaining operational stability and culture., • Strong communication, planning, and cross-functional leadership skills., • Lean/Six Sigma knowledge/certification, preferred., • Bilingual (English/Spanish) highly preferred. Essential Physical Requirements • Ability to regularly walk, stand, and move throughout the manufacturing facility., • Ability to navigate stairs, catwalks, and uneven surfaces safely., • Ability to visually and audibly observe operations and employee practices., • Ability to wear required PPE (hair/beard nets, safety shoes, gloves, safety glasses, hearing protection)., • Ability to work in varying environmental conditions (heat, cold, noise, humidity)., • Ability to sit for extended periods while performing administrative work., • Ability to travel locally as required., • Ability to communicate clearly and effectively. We offer a comprehensive compensation package that includes a base salary (to $185k,) plus bonus eligibility, paid time off, holiday pay, medical, dental, vision, and life insurances, FSA, EAP, and 401(k.) Applicants should submit a resume to for immediate consideration.

Position: Manufacturing Associate Duration: 06 Months Location: Summit West, NJ, 07901 Manufacturing Associate Abecma (Quad 4 Thu-Sat, alt Wed 3pm-3:30 am) Training schedule: 4-6 weeks, ONSITE training (9 - 5, Mon - Fri) Description: Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. • Required Competencies: Knowledge/ Skills, and Abilities:, • Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique, • Knowledge of cGMP/FDA regulated industry, • Basic mathematical skills - General understanding of cGMPs, • Technical writing capability, • Proficient in MS Office applications, • Background to include an understanding of biology, chemistry, medical or clinical practices Pre-requisites: Entry- Level, • Duties and Responsibilities:, • Production of blood component lots through cell culture, harvest, and cryopreservation., • Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum., • Weighs and measures in-process materials to ensure proper quantities are added/removed., • Adheres to the production schedule ensuring on-time, internal production logistics., • Records production data and information in a clear, concise, format according to proper GDPs., • Works in a team based, cross-functional environment to complete production tasks required by shift schedule., • Motivated, team consciousness individuals are needed to fulfill job requirements., • Leads a team within a designated function of manufacturing, however, supervision will be managed by the shift Supervisor., • No direct reports will be assigned to this job role., • Performs other tasks as assigned., • Education and Experience: Bachelor's degree or Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience or High School diploma/GED and 4 years of Manufacturing or Operations experience Important Notes about working in the clean room: This position takes place in a GMP clean room environment, which includes being gowned for up to 6 hours. During the processing time in the clean room, no breaks may be taken Working Conditions: • Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. - Physical dexterity sufficient to use computers and documentation., • Sufficient vision and hearing capability to work in job environment., • Ability to lift up to 25 pounds., • Must have the ability to work around laboratories and controlled, enclosed, restricted areas., • Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet., • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas., • Flexibility to don clean room garments and personal protective equipment (PPE)., • Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected., • Routine exposure to human blood components.

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. QuidelOrtho is seeking a Manager, Data Analytics. The Manager, Data Analytics is a global people leader within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This leader is responsible for developing and leading a team of Quality professionals to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth. This role provides strategic direction and operational oversight across Quality disciplines. operate under little to no direct supervision and provide independent guidance to the business. This position is considered a subject matter expert in Quality Data Analytics and Complaint Trending. They are accountable for the work of the Quality Data Analytics team and the success of team projects; and will have significant amounts of critical organizational and technical knowledge. This leader is responsible for the day-to-day management and supervision of Quality Engineers and Data Analysts and is also accountable for developing talent, strengthening scientific and compliance capabilities, and fostering a culture of engagement, collaboration, and performance. By integrating technical expertise, data-driven insights, and agile leadership behaviors, the Manager, Data Analytics ensures that Quality systems and teams deliver sustainable business and compliance outcomes. This position will be Hybrid in any global QuidelOrtho site. * Provides independent guidance to business partners on quality data handling and analytics. Establish dashboards and data visualizations to support product quality and continuous improvement. * Leads metrics and data analytics work for Complaints, Recalls, NC, CAPA, Audits/Compliance and other areas of Quality. * Ability to manage complaint trending activities and related software system validations * Ability to compile and present quality data and analysis to the business eg: Management Review. * Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives. * Establishclear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs. * Provide technical, regulatory, and operational leadership to ensure Quality systemscomply withISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements. * Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency. * Promote a culture of continuous improvement byidentifyingopportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS). * Ensure the teammaintainsa state ofinspectionreadiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits. * MonitorQuality performance using metrics and data analytics toidentifyrisks, drive root cause analysis, and implement sustainable improvements. * Coach and mentor emerging Quality team members to build organizational capability and ensure robust succession planning. * Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders. * Ability to identify and drive process improvements; own process investigations, nonconformance records or corrective actions in response to audit findings. * Perform other work-related duties as assigned. Required: * Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required. * 7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership. * Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR. * Proven ability to lead and develop high-performing teams and build future technical and people leaders * Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations. • Excellent collaboration, influence, and communication skills across functional and organizational boundaries., • Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement., • Experience leading in a matrixed, global organization and managing competing priorities effectively., • Commitment to scientific integrity, compliance excellence, and continuous improvement. Preferred: * Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline. * Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools. * Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise. * Experience supporting or leading Health Authority or Notified Body inspections. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. Typical office or laboratory environment. May involve virtual collaboration across multiple global sites. No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: * Thrive Together - Collaborate intentionally, grow as a team * Make It Happen - Focus on priorities, embrace continuous improvement * Commit to Service - Cultivate a service mindset * Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $135,000 to $175,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-SP1

(Senior) Director, CMC QA – Permanent – New York Proclinical is seeking a (Senior) Director, CMC Quality Assurance for an emerging biotech company based in New York. Primary Responsibilities: In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities. The position is based onsite in New York. Skills & Requirements: • B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional., • Experience in small molecule development, batch release, and SOP drafting., • Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections., • Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products., • Proven ability to build or scale quality systems in a dynamic environment., • Prior experience managing CDMOs and external quality oversight strongly preferred., • Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred. The (Senior) Director, CMC QA will: • Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards., • Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies., • Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations., • Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management)., • Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams., • Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs)., • Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment. If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or . Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

The Senior Account Executive is a key client partner responsible for managing day-to-day relationships and leading the execution of integrated pharmaceutical and healthcare marketing initiatives in a regulated environment. This role serves as the central liaison between clients and internal teams, ensuring projects are delivered on time, within budget, and aligned with client business objectives. Working closely with strategy, creative, media, medical, and project management teams, the Senior Account Executive helps drive the successful execution of campaigns while maintaining compliance with Medical, Legal, and Regulatory (MLR) review processes, FDA guidelines, and healthcare marketing best practices. The role also supports account growth, contributes to strategic discussions, and mentors junior team members to ensure strong collaboration and high-quality deliverables. Candidates with experience at the Senior Account Executive or Account Supervisor level are encouraged to apply; title and compensation will be commensurate with experience. This position is based in New York City and follows a hybrid work model, requiring three days in the office (Tuesday–Thursday). Key Responsibilities Client Partnership & Account Leadership • Serve as a primary point of contact for assigned healthcare and pharmaceutical clients, building trusted relationships and ensuring clear communication across projects and initiatives., • Manage day-to-day account activities, ensuring work is aligned with client objectives, timelines, and budgets., • Lead the development of project briefs and ensure internal teams are aligned on deliverables, timelines, and expectations. Campaign Execution & Cross-Functional Collaboration • Partner with strategy, creative, medical, digital, media, and project management teams to deliver integrated marketing campaigns across channels., • Ensure work is on strategy, compliant with healthcare regulations, and delivered with high quality and accuracy., • Support the development of client presentations, status updates, and strategic recommendations., • Mentor and support junior account team members, helping maintain strong team collaboration and performance. Financial Management & Account Growth • Support account leadership in managing project budgets, scopes of work, and financial tracking., • Monitor timelines and budgets to ensure projects remain within scope and identify potential risks early., • Contribute to identifying opportunities to expand client partnerships and grow the agency’s scope of work., • Participate in strategic discussions and long-term planning for key accounts as appropriate. Qualifications • 3–6 years of experience in account management within an advertising, marketing, or healthcare communications agency., • Experience supporting pharmaceutical, biotech, or healthcare brands within a regulated marketing environment., • Familiarity with Medical, Legal, and Regulatory (MLR) review processes and development of compliant marketing materials., • Demonstrated ability to manage multiple projects and timelines in a fast-paced agency environment., • Experience collaborating with cross-functional teams including creative, strategy, media, medical, and analytics., • Strong communication and presentation skills with the ability to interact confidently with clients and internal teams., • Understanding of integrated marketing campaigns across multiple channels., • Bachelor’s degree in Marketing, Advertising, Communications, Business, or a related field., • Title and compensation will be commensurate with experience. EQUAL OPPORTUNITY EMPLOYER Moon Rabbit embraces and celebrates diversity, inclusivity, and equal opportunity. We are committed to building a team that reflects a wide range of backgrounds, perspectives, and experiences. As a global agency serving global clients, we believe that a more inclusive workplace enables us to produce stronger, more impactful work together. Moon Rabbit is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.

About Us United Premium Foods is an equal opportunity employer who wishes to hire motivated individuals to join our team working in our food production and cold storage facility. We are a fast-growing manufacturer of superior quality food (protein-based) products and provider of cold storage services. We are dedicated to delivering exceptional food processing solutions that prioritize quality, safety and superior customer service. Our commitment to excellence is evident in our New Jersey based facility, which is USDA and FDA Level 2 certified, and in our rigorous processes designed to meet stringent safety and food safety regulations. About the Role We are seeking a dynamic and experienced Food Safety and Quality Manager with strong customer relationship and communication skills as well as extensive experience in leading and managing teams to establish high standards for food production facilities. The ideal candidate will implement robust quality control protocols, maintain a compliant food safety environment, and oversee sanitation protocols. This candidate must possess a strong understanding of FDA and USDA regulations, as well as experience in quality system management. In this role, you will provide leadership to the food safety and quality team, guiding them to uphold best practices and achieve excellence. The candidate will develop, implement, and maintain food safety and quality SOPs and lead training initiatives for teams in established practices. The Food Safety and Quality Manager will manage team accountability for audit readiness, handle customer inquiries, administer lab results, and drive process improvement programs related to food safety and quality. This leadership role requires proactive troubleshooting skills to resolve quality assurance challenges, implement timely corrective actions, and develop preventative measures that align with company standards. Responsibilities The Food Safety and Quality Manager is responsible for leading and overseeing all aspects of food safety and quality assurance within the production facility. This role works closely with the plant’s management team—including production, operations, and facilities maintenance—to enforce rigorous cleaning and sanitation schedules, develop a high-performance team, and uphold the highest standards of food safety and quality. Additionally, the manager leads coordination with third-party vendors, labs, USDA inspectors, and auditors to ensure full compliance with federal, state, local, and organizational regulations and policies. The role involves daily leadership and oversight of food quality processes, managing team inspections and assessments, implementing HACCP principles, maintaining thorough quality records, and addressing any potential hazards to ensure ongoing compliance and operational excellence. • Oversee and manage quality control systems: Implement and maintain a robust quality management system to monitor product quality at every stage of production., • Lead inspections and audits: Perform and delegate regular internal inspections and audits of the production process, equipment, and facilities to ensure compliance with safety and quality standards., • Develop and manage strong Customer Relations: Foster trust and credibility, as well as maintain strong rapport with customer QA teams., • Lead and manage corrective and preventive actions (CAPA): Identify potential hazards, address non-compliance issues, and implement corrective and preventive measures to resolve quality and safety concerns., • Collaborate with and lead cross-functional teams: Work closely with production, operations, and maintenance teams to integrate food safety and quality practices into day-to-day operations., • Establish, oversee, and lead sanitation and cleaning processes: Lead the execution of strict cleaning and sanitation schedules to ensure a hygienic production environment., • Train and mentor staff on food safety and quality standards: Develop and deliver training programs to ensure all employees understand and follow food safety and quality policies and procedures., • Oversee product testing and lab results: Manage lab testing of raw materials, in-process products, and finished goods to verify adherence to quality and safety standards., • Develop, implement, and lead food safety protocols: Establish and maintain food safety programs, including HACCP, to ensure compliance with regulations and industry standards., • Ensure audit readiness and team preparedness: Prepare and maintain all necessary documentation and records for third-party and regulatory audits., • Drive continuous improvement within the team: Lead initiatives to enhance food safety and quality processes, including monitoring trends and implementing industry best practices., • Maintain thorough SOP documentation and team adherence: Ensure that all records related to food safety and quality, such as inspection reports, ATP swabbing, audit results, and compliance documentation, are accurate and up to date. Qualifications • Bachelor’s degree in food science, microbiology, chemistry, or related field., • Minimum of 8+ years of experience in a leadership role within food safety, quality assurance, or quality control within a food production environment., • In-depth knowledge of food safety regulations and standards (HACCP, GMP, FDA, USDA, FSMA)., • HACCP certification required (Preventive Controls Qualified Individual or SQF practitioner is preferred)., • Proven leadership ability with a strong work ethic, capable of mentoring, guiding, and managing cross-functional teams in food safety and quality practices., • Bilingual in Spanish is a plus. Working Conditions • Food manufacturing environment and cold storage warehouse. Ability to commute/relocate: • Woodbridge, NJ 07095: Reliably commute or relocate before starting work (Required).

Position: Manufacturing Supervisor Department: Operations Reports to: VP of Operations & Quality Position Summary: The Manufacturing Supervisor is responsible for overseeing daily manufacturing operations to ensure production activities are completed safely, efficiently, and in compliance with company procedures and regulatory requirements. This role supervises manufacturing staff, coordinates production schedules, and works cross-functionally with Packaging, Engineering, and Quality to ensure consistent product output for gel-based medical device and OTC products. Key Responsibilities • Supervise and direct manufacturing staff to ensure production activities are completed on schedule and according to company policies and procedures., • Ensure the manufacturing team adheres to company SOPs, safety regulations, and regulatory requirements including FDA, cGMP, ISO 13485, MDD, and CMDR standards., • Coordinate production runs with the Packaging Department to ensure proper materials are available and production schedules are maintained., • Oversee the efficient and accurate manufacturing of core products, imprints, and special orders., • Participate in weekly production planning meetings and provide updates on manufacturing status and challenges., • Monitor production performance and prepare production reports as required, including adherence to the weekly production schedule., • Work with Engineering to support modifications, troubleshooting, and improvements to processing equipment and manufacturing processes., • Ensure manufacturing documentation is completed accurately and in accordance with quality system requirements., • Maintain a safe, clean, and organized production environment., • Support training of manufacturing staff and participate in internal training initiatives., • Complete special projects and operational initiatives as assigned by management. Skills & Competencies • Strong leadership and supervisory skills with the ability to motivate and guide teams, • Excellent interpersonal and communication skills, • Ability to enforce policies and procedures while maintaining positive team relationships, • Strong organizational and problem-solving abilities, • Detail-oriented with a strong focus on quality and compliance, • Ability to manage multiple priorities in a fast-paced manufacturing environment, • Team-oriented with strong collaboration skills, • Proficiency in Microsoft Office applications Qualifications • Minimum of 3 years of supervisory experience in a manufacturing environment, • Experience working in regulated manufacturing environments (medical device, pharmaceutical, cosmetics, or similar industries preferred), • Bachelor’s degree in a technical or engineering-related field preferred, • Knowledge of cGMP, FDA regulations, and ISO 13485 standards preferred, • Experience with production scheduling and manufacturing reporting Work Environment • This role operates primarily in a manufacturing environment and requires regular interaction with production and packaging personnel, engineering staff, and quality teams.

Summary We are seeking an experienced Manufacturing Process Engineer with experience in powder-based manufacturing, with a strong chemistry background to lead and optimize manufacturing operations. This role is responsible for the design, improvement, and oversight of production processes, ensuring efficiency, quality, safety, and regulatory compliance. The ideal candidate combines hands-on plant experience with technical leadership, customer interaction, and cross-functional collaboration to drive continuous improvement across operations. Key Responsibilities • Design, develop, test, and improve mechanical systems, equipment, and process applications., • Analyze and optimize chemical and manufacturing processes to increase throughput, improve efficiency, and reduce waste., • Schedule and manage production operations involving blending, milling, drying, and screening equipment for maximum efficiency., • Lead employees across production and technical operations., • Oversee preventive maintenance and downtime activities to ensure operational reliability., • Conduct client laboratory testing, including data intake, feasibility studies, process development, optimization, and final reporting; ensure high client satisfaction., • Perform root cause analysis on process failures and implement corrective and preventive actions., • Manage operational budgets and present performance metrics and financial results to leadership., • Collaborate with operations, R&D, quality, and regulatory teams to implement new or improved processes., • Develop, maintain, and manage technical documentation, including SOPs, certifications, regulatory filings, and compliance records., • Bachelor’s degree in Chemical Engineering, Process Engineering, or a related field., • Minimum of 5+ years of process engineering experience, • Experience in powder-based manufacturing within pharmaceutical, nutraceutical, cosmetic, or chemical industries., • Hands-on experience with laboratory equipment, including particle size analyzers, microscopes, moisture balances, and scales., • Proven ability to work directly with customers and present technical findings., • Strong understanding of chemical engineering fundamentals, including fluid dynamics, thermodynamics, and heat transfer., • Knowledge of industrial electrical control panels and their integration with manufacturing equipment., • Strong regulatory background, with responsibility for maintaining FDA, DEP, EPA, cGMP, SQF, and related programs., • Proficiency with CAD and process simulation software is a plus., • Excellent analytical, problem-solving, and organizational skills.

Medical Device Leader! Principal Quality Engineer Opportunity! This Jobot Consulting Job is hosted by: David DeCristofaro Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $65 - $85 per hour A bit about us: We are a leading medical device company that operates privately and is committed to enhancing the care and quality of life of patients with kidney disease. Our goal is to create cutting-edge solutions that enable patients and their healthcare providers to manage kidney disease with ease. Why join us? • Company Equity!, • Excellent medical, dental, & vision package!, • 401(k) with a match!, • Generous PTO!, • Opportunity to make a difference in people's lives! Job Details We are seeking a dynamic and experienced Principal Quality Engineer to join our team. This role will be responsible for leading the quality engineering initiatives ensuring ongoing safety, efficacy, and compliance of medical devices as they enter the market. The ideal candidate will have a strong background in quality engineering within the Medical Device industry, with a focus on FDA regulations, ISO 13485, CAPA, and other regulatory and compliance requirements. Responsibilities: 1. Lead the development and implementation of quality systems in compliance with FDA and ISO 13485 regulations., 2. Analyze and manage Corrective and Preventive Actions (CAPA) to ensure effective resolution of quality issues., 3. Utilize problem-solving methodologies such as Fishbone or DMAIC to identify root causes and implement corrective actions., 4. Maintain the FDA Quality Management System Reporting (QMSR) and ensure that all quality metrics are met or exceeded., 5. Provide consultation to various departments on quality systems, regulatory compliance, and risk management., 6. Conduct internal and external audits to ensure compliance with regulatory standards., 7. Lead and oversee post-market surveillance programs., 8. Collaborate with cross-functional teams to drive continuous improvement initiatives., 9. Lead the review and approval of design and process changes, ensuring compliance with quality standards and regulatory requirements. Qualifications: 1. Bachelor's degree in Engineering, Quality Assurance, or a related field is required., 2. Minimum of 12 years of experience in a quality engineering role with strong medical device industry experience., 3. Extensive knowledge of FDA regulations, ISO 13485, Fishbone, DMAIC, 8D, and/or FDA QMSR., 4. Expertise in post-market quality system activities including complaint handling, vigilance/adverse event reporting, HHE, and post-market surveillance., 5. Conduct and lead complex investigations and implement CAPA., 6. Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is preferred. Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

DESCRIPTION Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE As the Principal Packaging Engineer, you will serve as the enterprise-wide technical expert and strategic lead in FDA regulated packaging. The position leverage deep knowledge in packaging including but not limited to design, test methods, standards, and industry insights to create and deliver a pipeline of breakthrough innovations and overall organizational improvement. You will operate with a high degree of autonomy, and lead with accountability projects from concept to commercialization. A proactive approach in identifying opportunity areas and a strong drive for results and overall organizational improvement is essential. This role requires excellent communication skills to effectively collaborate across functions, influence stakeholders and ensure alignment with organizational goals. The Principal Engineer must take responsibility for technical mentorship and coaching, fostering technical growth and knowledge of junior engineers while strengthening the team’s technical capabilities. As a recognized expert, you will guide internal and external teams on the application of packaging standards (e.g., CCIT, ISO 11607, USP <1207>, USP <661>, etc.), and represent the company in regulatory interactions, technical forums, and industry partnerships. Success requires exceptional problem-solving skills, strategic influence, and proven ability to align cross-functional teams toward breakthrough innovation. This role is accountable for delivering measurable outcomes and ensuring that packaging innovations translate into tangible business impact. ESSENTIAL FUNCTIONS AND BASIC DUTIES Technical Leadership, Data Analysis and Interpretation • Demonstrate strong ownership and leadership on technical strategies and problem solving while driving projects from concept to commercialization., • Own the technical roadmap for packaging innovation and ensure alignment with business priorities., • Take responsibility for the accuracy, integrity, and impact of technical data used to inform decisions., • Design and direct meaningful and robust research projects or experiments both internally and externally through relationships with academic institutions and industry partners., • Facilitate knowledge sharing and foster collaborative research initiatives while mentoring, coaching and guiding junior engineers., • Analyze experimental data to draw meaningful conclusions from research and guide further development., • Ensure robust statistical methods are applied where necessary., • Develop innovative solutions to address technical challenges., • Act as subject matter expert in packaging for FDA regulated products (expert in packaging standards such as CCIT, ISO 11607, USP <1207>, USP <661>, etc)., • Identify, scope and represent the organization at key conferences, seminars and other professional events., • Exhibit a proactive mindset in identifying, vetting and implementing new opportunities for innovation and improvement of the organization., • Demonstrate ability to think strategically and influence the organization on key initiatives., • Champion initiatives that deliver quantifiable improvements in product performance, cost efficiency, or regulatory compliance., • Lead cross-functional teams to bring strategic innovations from concept to launch, ensuring accountability at each stage., • Develop and execute innovation strategies aligned with business goals, including new technologies, methods, and IP creation., • Lead the development of new products, technologies, and methods that deliver measurable impact and enhance organizational success., • Define, communicate and align project goals and request necessary resources for execution cross functionally., • Hold self and cross-functional teams accountable for meeting project milestones, quality standards, and business objectives., • Ensure post-launch evaluation and continuous improvement based on performance metrics., • Demonstrate strong interpersonal and influencing skills to drive initiatives forward and overcome challenges., • Ensure accountability to milestones and objectives while demonstrating strong ownership, coordination and leadership in project execution, anticipating risks, and implementing mitigation strategies to ensure timely and high-quality delivery., • Demonstrate excellent communication skills in preparing and presenting progress updates, status, reports and findings to senior level management. PERFORMANCE MEASUREMENT • Packaging Leadership and Effectiveness: leads packaging design development that meets intended performance, safety and regulatory requirements, • Project Acceleration and Execution: Demonstrates initiative in shaping project direction, anticipating potential obstacles and proposing solutions to ensure timelines are met or accelerated. Consistently delivers technical work on time, in scope and aligned to evolving business priorities, • Strategic Technical Problem Solving: Anticipates and identifies complex packaging development challenges early, leveraging expertise and leadership to drive resolution paths with minimal rework and high technical rigor., • Cross-Functional Influence and Alignment: Actively engages and influences cross-functional partners (Regulatory, Marketing, Operations, Quality) to ensure clarity of technical direction, ensure alignment and provide technical strategies, expertise and data to remove barriers impeding project progress, • Pipeline Advancement and Opportunity Identification: Proactively scans internal and external landscapes to identify new opportunities, unmet needs and technology enablers that can strengthen the pipeline and move concepts into development, • Performance will be evaluated based on the ability to deliver projects on time, within scope, and with measurable business impact., • Expected to take full ownership of assigned initiatives and proactively resolve barriers to success. QUALIFICATIONS EDUCATION/CERTIFICATION • New Product development and leadership in a regulated environment., • Strong analytical thinking capabilities and mindset, • Strong sense of accountability and commitment to delivering results with excellence and timeliness, • Excellent communication and interpersonal skills, • Ability to make sense of, organize and present complex information, • Proven ability to work independently and take initiative in ambiguous or evolving environments, • Ability to set specific goals for self and others and organize/align the resources to help achieve goals, • Demonstrated ability to manage multiple projects with varying complexity, • Ability to evolve, learn and implement new systems and programs, • Initiative taker, ambitious and driven, • Resourceful and able to find creative and innovative ways to achieve results, • Demonstrated accountability for project outcomes and ability to drive initiatives to successful completion., • $128,000 - $141,000 annually BENEFITS PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes: • Medical, behavioral & prescription drug coverage, • Health Savings Account (HSA), • Dental, • Vision, • 401(k) savings plan with company match and profit sharing, • Basic and supplemental Life and AD&D insurance, • Flexible Spending Accounts (FSAs), • Short & long-term disability, • Employee Assistance Program (EAP) At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

Physician Assistant – Clinical Research (Sub-Investigator) Location: Brooklyn, NY About Brooklyn Clinical Research: Brooklyn Clinical Research was founded to increase access to clinical trials for underrepresented populations. Clinical-trial enrollment should accurately represent the broader population. In meeting this objective, we help improve therapeutic efficacy and safety for all individuals. Position Overview: We are seeking a clinically adept, highly motivated Physician Assistant to join our growing research team as a Sub-Investigator. This is a hands-on clinical research role, working alongside our full-time Principal Investigator (MD) to conduct industry-sponsored clinical trials. The ideal candidate will thrive in a fast-paced, dynamic environment where flexibility, strong clinical decision-making, and attention to detail are essential. You will receive full training in clinical research and GCP, and you will play a key role in the daily conduct of clinical trials — performing protocol-specific assessments, managing study visits, and ensuring participant safety and regulatory compliance. Key Responsibilities: • Serve as a Sub-Investigator on assigned clinical trials under supervision of the Principal Investigator., • Perform protocol-required medical evaluations, including detailed histories, physical exams, safety assessments, and medical oversight of study participants., • Administer investigational products (e.g., vaccines, injectables) according to protocol., • Perform and oversee clinical procedures including phlebotomy, vital signs, ECGs, and other protocol-specified tests., • Assess and document adverse events and serious adverse events according to FDA and Sponsor guidelines., • Maintain thorough, timely, and accurate source documentation and electronic data entry (EDC, eSource, CTMS)., • Collaborate closely with clinical coordinators, regulatory staff, sponsors, and CROs., • Participate in monitoring visits, audits, and inspections., • Maintain comprehensive knowledge of study protocols, informed consent documents, and regulatory requirements., • Participate actively in team meetings, contributing to ongoing process improvement as our site grows., • Act as a supplementary Clinical Research Coordinator on an as-needed basis. Qualifications: • Graduate of an accredited Physician Assistant program (required)., • Active Physician Assistant license in New York State (required)., • Prior clinical research experience is a strong plus but not required., • Extensive background in direct patient care., • Current BLS/CPR certification. Key Attributes for Success: • Excited to work in a fast-paced clinical environment where protocols and patient needs can vary daily., • Strong clinical acumen and independent judgment., • Detail-oriented with excellent documentation skills., • Highly organized with the ability to manage multiple protocols simultaneously., • Excellent communication and teamwork skills., • Commitment to patient safety, protocol adherence, and research integrity., • Spanish fluency or medical Spanish is a plus but not required. Position Details: • Full-time, salaried position, Monday–Friday. Occasional weekend work may be required during high-volume vaccine periods., • Anticipated Start Date: Late July or Early August 2025, • Salary Range: $140,000 to $170,000 depending on experience. Why Join Us: This is an excellent opportunity for a PA who is interested in advancing their career into clinical research while maintaining direct patient interaction. You will be a key member of a high-performing, mission-driven team with meaningful opportunities for professional growth as our research site expands. Notice to Recruiters and Agencies We do not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please do not forward resumes to our employees or any company location/contact. Brooklyn Clinical Research is not responsible for any fees related to unsolicited resumes. We will consider any CV or resume received without a prior, signed agreement to be the property of Brooklyn Clinical Research, and we will process it accordingly without fee or obligation.

Clinical Research Coordinator Location: Brooklyn, NY About Brooklyn Clinical Research: Brooklyn Clinical Research was founded to increase access to clinical trials for underrepresented populations. Clinical-trial enrollment should accurately represent the broader population. In meeting this objective, we help improve therapeutic efficacy and safety for all individuals. Position Overview: The Clinical Research Coordinator (“CRC”) monitors data management and regulatory aspects of clinical-trial operations and will ensure that research is conducted in accordance with the sponsor’s protocol, FDA Regulations, and ICH/GCP guidelines. The CRC will also ensure that the data provided to the sponsor are of the highest quality and that study enrollment meets or exceeds the sponsor’s expectations. As such, the CRC should be a detailed-oriented, self-motivated professional with a track record of successfully adhering to clinical-trial protocols and exceeding sponsor expectations. Our primary therapeutic areas are pain, cardiometabolic health, and vaccines. Estimated Start Date: March or April, 2026 DUTIES & RESPONSIBILITIES • Completing all relevant training prior to study start and all additional protocol amendment trainings., • Adherence to ALCOA-C Standards with all clinical trial documentation., • Working effectively with EDC, CTMS, eSource, eRegulatory, and our internal database., • Working effectively with sponsor specified IVRS and EDC systems., • Conducting and overseeing study participant visits, and all other relevant protocol-required procedures -- including blood draws -- while documenting relevant data in a timely, accurate manner., • Completing and overseeing data entry and query resolution in a timely manner as per company guidelines and sponsor expectations., • Demonstrated understanding and implementation of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols., • Liaising with the administrative staff, clinical investigators, research participants, and Sponsor/CRO representatives for assigned protocols., • Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, organizational SOPs, and assigned study protocol(s)., • Maintaining a working knowledge of the recruitment and retention processes for the assigned protocol(s)., • Preparing for Sponsor and CRO visits for the respective protocol(s)., • Maintaining a comprehensive knowledge of the most recent versions of the Study Protocols, Informed Consents, Study Manuals, and all the other relevant study-related documents that are utilized for the assigned protocols., • Managing study participants’ scheduling, visit tracking, stipends, and transportation., • Maintaining a comprehensive knowledge of all essential clinical trial documents and maintenance of the Investigator Site Binders for their assigned protocol(s)., • Work with the Principal Investigator(s) on the reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per Sponsor, IRB, and ICH-GCP Guidelines., • Work supplementally with our recruitment team to pre-screen and schedule study participants. KNOWLEDGE & EXPERIENCE Education: • Bachelor's degree in health or science-related major preferred but not mandatory, • ICH-GCP Certification and IATA Certification, • Phlebotomy Certification Experience: • 2-3 years’ experience in industry-sponsored clinical research, preferably as a CRC., • Wide therapeutic range of clinical-trial experience preferred., • Regulatory research experience is a plus. Credentials: • ACRP or equivalent certification is a plus Knowledge and Skills: • Goals-driven while continuously maintaining quality., • Must be a detail-oriented and proactive self-starter., • Must have strong written and verbal communication skills., • Must have excellent customer service skills., • Bilingual in Spanish is a plus. Salary Range: $70,000 to $80,000 depending on experience and qualifications.

Senior Clinical Trial Manager- (Sponsor-Dedicated, Remote - US) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Location: Remote - United States (East or Central Time preferred) Where strategy meets operational excellence. We're seeking an experienced Senior Level Clinical Trial Manager join our sponsor-dedicated team in the role of Site Monitoring Lead (SML) to supporting global clinical research programs. In this fully remote role, you'll provide leadership and expertise in site monitoring strategy, execution, and oversight-ensuring clinical trial quality, subject safety, and data integrity across multiple regions. The SML serves as a core member of the Trial Team, leading the implementation of the site monitoring and oversight approach as part of overall trial quality management. This role is critical to delivering clinical programs on time and to the highest compliance standards, in alignment with ICH-GCP, regulatory expectations, and sponsor requirements. * Lead and oversee site monitoring activities across assigned global clinical trials, ensuring effective implementation of trial-specific monitoring strategies. * Consult and provide expertise to Trial Teams on monitoring methodologies, risk-based approaches, and oversight activities throughout all trial phases. * Ensure trial participant safety, data integrity, and regulatory compliance in accordance with study protocols, ICH-GCP, and applicable global regulations. * Manage trial-level planning, implementation, issue management, and risk mitigation related to site monitoring activities. * Support inspection readiness at all times by maintaining robust oversight, documentation, and communication processes. * Represent the function in meetings with investigational sites, vendors, and internal/external stakeholders, including regulatory agencies or inspectors when needed. * Contribute to innovation and process improvement, including the design and implementation of new monitoring methods and digital solutions related to trial delivery. * Collaborate cross-functionally with Clinical Operations, Quality, and other global teams to ensure seamless execution and alignment on monitoring objectives. * Bachelor's degree in Life Sciences or a related discipline; advanced degree preferred. * Demonstrated experience as a Clinical Trial Manager (or equivalent trial-level role) with accountability for end-to-end study execution, including planning, conduct, oversight, and closeout of clinical trials. This role requires ownership of the trial at the program level and is not a site-monitoring or CRA position. * Proven leadership of early-phase (Phase I and IIa) clinical trials, including operational strategy, risk management, and execution for complex, early-stage patient populations (not limited to first-in-human studies but must include). * Oversight-not execution-of site monitoring activities, including management and performance oversight of CRAs and/or CRO partners, issue escalation, and proactive risk mitigation. * Deep expertise in clinical operations with trial-level decision-making authority, including protocol implementation, deviation management, inspection readiness, and resolution of operational challenges. * Strong working knowledge of ICH-GCP, Good Documentation Practice, and global regulatory requirements, with the ability to apply these principles at the study oversight level across FDA, EMA, and PMDA-regulated trials. * Experience leading global, multi-regional trials within a matrixed, cross-functional environment, partnering closely with Clinical Operations, Data Management, Safety, Regulatory, Biometrics, and external vendors. * Demonstrated ability to manage CROs and functional vendors, including monitoring, central labs, imaging, and other service providers, ensuring delivery against timelines, quality, and study objectives. * Advanced project and trial management capabilities, including ownership of study timelines, milestone delivery, operational risk identification, and resolution across competing priorities. * Excellent communication and stakeholder management skills, with the ability to lead and influence CRAs, vendors, and cross-functional teams in a global, matrixed structure. * Demonstrated Agility, Accountability, and Intrapreneurship (AAI), with a results-oriented mindset, sound judgment, and the ability to make informed decisions in a fast-moving early-phase environment. * * Opportunity to shape and optimize site monitoring strategies across diverse, high-impact clinical programs. * Work within a collaborative, science-driven culture that values innovation, agility, and excellence in delivery. * Engage directly with global teams, vendors, and regulatory stakeholders to drive success from early development through marketing authorization. * A dynamic environment that rewards leadership, critical thinking, and operational insight. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $95,000.00 - $175,700.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Clinical Project Manager II - Biomarker Study Management (Sponsor-Dedicated | Remote) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities We're hiring a Clinical Project Manager II with a strong background in biomarker study operations to join our sponsor-dedicated team. This fully remote role gives you the opportunity to drive the success of global clinical trials by leading biomarker and bioanalytical strategy from start to finish. You'll be a key player in bringing together cross-functional teams, vendors, and internal stakeholders to ensure biological samples are collected, managed, and analyzed to the highest standards. What You'll Do: Lead Biomarker Study Operations * Oversee biomarker and bioanalytical activities across Sponsor and Collaborative programs * Serve as the operational point of contact for all biomarker-related processes * Work closely with clinical study teams (Phases 1-4) to integrate biomarker strategies into broader clinical development plans * Plan and manage the collection, tracking, and analysis of biological specimens * Advise study teams on best practices for sample management and logistics Drive Clinical Project Delivery * Lead cross-functional teams through the full clinical trial lifecycle, from start-up to closeout * Ensure studies stay on track with respect to timelines, budget, scope, and quality * Act as the main liaison between the sponsor and study partners * Monitor and manage project financials, ensuring fiscal responsibility * Proactively identify and resolve operational issues and risks Ensure Operational Excellence * Maintain high-quality documentation, including Trial Master File (TMF) accuracy and completeness * Keep study systems and databases current and audit-ready * Prepare project reports and updates for sponsors and internal stakeholders * Plan and facilitate internal and external meetings * Support inspection readiness and regulatory compliance throughout the project * Significant experience managing biomarker studies and external vendors required! * Strong understanding of biomarker and bioanalytical strategies in a clinical trial setting * Proven ability to coordinate complex sample collection and analysis workflows * Expertise in supporting study teams with sample logistics and operational planning * Bachelor's degree in Life Sciences, Medicine, Pharmacy, Nursing, or equivalent combination of education and experience * Experience in a clinical research organization (CRO) or sponsor environment preferred * Familiarity with GCP, ICH guidelines, and global regulatory standards * Strong project management, organizational, and communication skills * Comfortable working independently and embracing new technologies * Willingness to travel up to 25% as needed * Meaningful Work: Your contributions will directly support critical biomarker research that shapes the future of clinical development and precision medicine. * Global Impact: You'll be working on high-profile studies that span multiple regions, making a real difference in patients' lives around the world. * Dedicated Team: Join a collaborative, sponsor-dedicated environment where your expertise is trusted, and your voice matters. * Flexibility: Enjoy the freedom of a fully remote role with the support of a structured, responsive team. * Professional Growth: Be part of a company that invests in your career through continued learning, mentorship, and leadership opportunities. * Stability and Vision: Work with a leading global organization known for operational excellence and long-term partnerships in clinical research. If you're passionate about clinical research and want to make a direct impact on advancing biomarker science, we'd love to hear from you. Apply now and be part of a team shaping the future of clinical development. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Experienced Clinical Research Associate - Full-Service - Oncology Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution., • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills, • Ability to manage required travel of up to 75% on a regular basis, • US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Site Care Partner (Sr CRA II) - Sponsor Dedicated | Oncology | 5 years of monitoring experience required (Home-Based - United States) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and action items to resolution., • Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements., • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions., • May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected., • Ability to manage required travel of up to 75% on a regular basis At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $80,600.00 - $145,000.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Position: Manufacturing Associate Duration: 06 Months Location: Summit West, NJ, 07901 Breyanzi activation MO QUAD SCHEDULE: Breyanzi MO Associate Shift 2 Tuesday- Saturday (1pm-10pm) Training schedule: 4-6 weeks, ONSITE training (9 - 5, Mon - Fri) Description: Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. • Required Competencies: Knowledge/ Skills, and Abilities:, • Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique, • Knowledge of cGMP/FDA regulated industry, • Basic mathematical skills - General understanding of cGMPs, • Technical writing capability, • Proficient in MS Office applications, • Background to include an understanding of biology, chemistry, medical or clinical practices Pre-requisites: Entry- Level, • Duties and Responsibilities:, • Production of blood component lots through cell culture, harvest, and cryopreservation., • Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum., • Weighs and measures in-process materials to ensure proper quantities are added/removed., • Adheres to the production schedule ensuring on-time, internal production logistics., • Records production data and information in a clear, concise, format according to proper GDPs., • Works in a team based, cross-functional environment to complete production tasks required by shift schedule., • Motivated, team consciousness individuals are needed to fulfill job requirements., • Leads a team within a designated function of manufacturing, however, supervision will be managed by the shift Supervisor., • No direct reports will be assigned to this job role., • Performs other tasks as assigned., • Education and Experience: Bachelor's degree or Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience or High School diploma/GED and 4 years of Manufacturing or Operations experience Important Notes about working in the clean room: This position takes place in a GMP clean room environment, which includes being gowned for up to 6 hours. During the processing time in the clean room, no breaks may be taken Working Conditions: • Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. - Physical dexterity sufficient to use computers and documentation., • Sufficient vision and hearing capability to work in job environment., • Ability to lift up to 25 pounds., • Must have the ability to work around laboratories and controlled, enclosed, restricted areas., • Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet., • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas., • Flexibility to don clean room garments and personal protective equipment (PPE)., • Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected., • Routine exposure to human blood components.

Job Description Summary At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals. The Engineering Specialist will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives. Responsible for execution of maintenance and calibration activities and commissioning activities for projects at site level. Location: Onsite Job Description Major accountabilities: • Adhere to Novartis Quality Policies and procedures as they pertain to the position to ensure that all products are safe, pure, effective and of the highest quality., • Perform a wide range of maintenance repair activities on production equipment, lab equipment and building management systems., • Provide guidance and leadership to team members., • Assist in troubleshooting and repair of process equipment (example: containment isolator systems, filling line equipment and associated utility connections) which may include mechanical, electrical wiring, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, compressed gases, filling line, under little to no supervision., • Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs., • Support 24x7 site-based operations after startup., • Write/revise accurate operational procedures, training documents and maintenance procedures for various production and utility systems., • Provide radiation safety program support, responsible for calibration and functionality of all radiation detection equipment, • Completes Equipment Work Order Thoroughly, and Accurately and Documents them in the System, • Supply information and technical data for securing spare parts., • Provide responsive customer support with emphasis on customer satisfaction., • Perform startup and commissioning activities as required., • Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs, • Perform preventative and corrective maintenance on manufacturing process related equipment within a cleanroom environment., • Complete and provide accurate documentation, as required in cGMP operations., • Oversee work and provide training of less experienced maintenance technicians and/or new technicians., • Other related duties as assigned., • Use of CMMS system for documentation of relevant work. The salary for this position is expected to range between $85,400 and $158,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Minimum Requirements: • High School diploma or equivalent is required; bachelor's degree is preferred., • 3+ years of relevant hands-on plant maintenance experience in a regulated GMP environment is required., • Previous supervisory, team/project lead experience is preferred., • Previous aseptic fill/finish and/or radio pharmacy experience is preferred., • Previous pharmaceutical or medical device experience is preferred., • Completed training in radioactive or hazardous materials environment is preferred., • Must be able to adhere to all applicable procedures, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.), • Experience working in a team environment, with excellent communication and organizational skills., • Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) or similar system., • Ability to climb ladders and lift up to 50 lbs., • Wear and work in protective clothing, including respiratory protection, confined space entry and clean room environments., • Must be flexible to work nights, weekends, and holidays as required. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $85,400.00 - $158,600.00 Skills Desired Agile (Programming Methodology), Architectural Engineering, Aws (Amazon Web Services), Business Continuity, Business Networking, Change Control, Computer Science, Construction Management, Cost Management, Flexibility, General Hse Knowledge, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Installations (Computer Programs), Knowledge Of Capa, Knowledge Of Gmp, Knowledge Of Relevant Tools And Systems, Manufacturing Production, Project Commissioning, Project Engineering, Project Execution, Risk Management, Root Cause Analysis (RCA), Software Development, Total Productive Maintenance

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Manager, Lifecycle Maintenance will advance the maintenance global clinical regulatory compliance for investigational and marketed products and manage the maintenance of study files in eCTD format. This position will contribute to the organization in the design and conduct of clinical trials in conformance with Health Authority requirements and the management of clinical trial documentation to support clinical submissions. Essential Functions • Lead Lifecycle Maintenance staff by delegating projects, establishing and meeting timelines, and ensuring high quality work products, • Manage the day-to-day activities of staff to include the hiring and training of new team members, coaching employees and monitoring performance., • Provide input to the design and reporting of clinical studies performed by IBRX or by CROs, • Manage the review, cataloguing, and submission of documents including investigator brochures, protocols, informed consent forms, clinical study reports, annual reports, DSURs, PSURs, PAERs, and clinicaltrials.gov entries in the US and abroad, • Manage all protocol supportive documentation including the cataloguing and submission of essential investigator qualification documents, • Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan, • Create and maintain project plans for regulatory lifecycle maintenance operations, • Monitor FDA and other healthauthority guidance, prepare supplemental dossiers, and manage the lifecycle documentation for postapproval changes., • Lead datadriven strategic initiatives to maintain comprehensive regulatory documentation, ensuring compliance and supporting organizational objectives., • Oversee configuration, maintenance, and user support for internal platforms used for file storage., • Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications, • Manage the internal review of the relevant clinical sections of written summaries for regulatory submissions including INDs, NDAs, and BLAs, • Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 7+ years relevant progressive experience required; or, • Master's degree in life sciences or technical discipline with 5+ years relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 3+ years relevant progressive experience required, • Experience managing staff preferred, • Experience in the management and preparation of the submission of clinical modules in eCTD format required, • Experience with organizing responses to Health Authority information requests required, • Familiarity with global regulatory submissions (US and ex-US) strongly preferred Knowledge, Skills, & Abilities • Strong knowledge of Health Authority guidance documents and requirements, • Strong leadership skills with the ability to direct and develop professional staff, • Strong knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines, • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written and oral communication skills, and attention to detail Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval, • This position may need to sit for long periods of time and use various computer programs, • This desk-based role involves the close study of scientific and regulatory documents, • This position will work closely with scientific colleagues throughout the day, often on a project-team basis This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $165,000 (entry-level qualifications) to $181,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Job Description Summary Provide overall leadership, management, and strategic planning for the management of third-party service providers for the delivery of facility services at the East Hanover campus. Fully support facility services within both direct contract and integrated facility management (IFM) models. Responsibilities include facility management of the overall buildings, grounds, cleaning, food services, infrastructure and site maintenance operations. Develop strategic relationships with third-party service providers and Novartis business stakeholders. Recognized as competent in evolving facilities management and strategic planning to build and sustain competitive advantage. Facilitate and participate in the development of change management approaches required to implement them. Ensure close coordination with, and actively participate in, US REFS initiatives to maximize enterprise-wide opportunities. Work closely with campus associates to ensure customer satisfaction goals are achieved. Follow up with customers to understand customer issues, follow up with REFS suppliers to address issues, and keep customers informed of progress. Ensure adequate REFS support at campus events, FDA audits, etc. Job Description Major accountabilities: • Manage and govern third party service providers providing facility services to make sure that they adhere to baseline budgets, work to develop new scope of work, and maintain site operations 24/7 as necessary. Conceptualize, develop, and implement innovative short- and long-term business strategies to improve quality, productivity, customer service levels and cost efficiency. Ensure the facility services meet end user requirements stakeholder customer satisfaction, • Complete monthly reporting required by the US REFS Head, Novartis leadership, REFS senior leadership and site heads., • Ensure effective third-party contract management and governance. Determine service provider ratings for monthly/quarterly financial and operational performance indicators. Provide oversight and take corrective action quickly and decisively when performance falls short of expectation, adherence to contracts, or when conflict dispute resolution is required., • Partner with Novartis Procurement and participate in the request for proposal (RFP) process when evaluating new suppliers., • Safety and compliance management (GXP, FDA, USDA, AAALAC, OSHA, SOX, POP) including company policies and procedures. Advocate and enforces applicable Novartis standards, policies, procedures, and best practices in the implementation and/or maintenance of facilities and services. Works closely with the Novartis Health, Safety & Environment (HSE) team to ensure proper compliance via third party service provider and all contracted vendors., • Understand and operate under Novartis budgetary guidelines and manage expenses according to budget., • Demonstrate company values on a consistent basis., • Drive culture within organization that retains and develops talent to create a pipeline for organizational growth, as well as one which values diversity and embraces inclusive behaviors. Key performance indicators: * Cost effective operations - optimal balance direct/ contract services * High level of stakeholder engagement (internal customers & external partners) * First time quality - achievement of percentage objective * Timely resolution of organizational and operational issues * Budget compliance - meet established targets * Regulatory compliance - zero observations * Environmental compliance - adherence to region sustainability goals * Partner with internal stakeholders to understand, prioritize and respond to needs * Drives continuous improvement mindset in the organization and executing in the various Facility Management areas of operational excellence Minimum Requirements: Education: Bachelors degree required. Work Experience: • 5-8 years of experience in a facility management/ maintenance environment., • Strong financial competency with budgeting, capital planning and maintenance., • Leadership and innovation. The ability to focus the organization on a common objective., • Extensive pharmaceutical facility operation experience., • Regulatory knowledge as related to pharmaceutical industry. Knowledge and understanding of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and other regulatory regulations regarding facility operations., • Strong knowledge of facility/ building/ utility operations and services, and the ability to understand corporate perspective, strategic and financial., • Competency in analytical and problem-solving skills., • Ability to develop and maintain partnerships with internal as well as external organizations to achieve goals. Ability to build relationships and manage key vendors., • Ability to be a champion for change and continuous improvement across REFS and the business. Flexibility and Adaptability., • Proven success in a collaborative environment, Ability to excel in cross-functional teams with multiple stake holders., • Strong communication skills, both written and verbal. Languages: * English Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $108,500 and $201,500/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $108,500.00 - $201,500.00 Skills Desired

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Manager, Veeva RIM will provide strategic and strategic leadership and oversight for Veeva RIM. The manager will manage the day-to-day management and operations of Veeva RIM, ensuring accurate, timely, and compliant uploads and maintenance of regulatory submissions and related documentation across US and ex-US regions. This role parents closely with Clinical, Nonclinical, and CMC regulatory teams to support all regulatory activities. This position will assist and direct staff in the use of Veeva RIM software to ensure that all regulatory content, submissions, and processes are managed efficiently, accurately, and in full compliance with global regulations. Essential Functions • Lead the Regulatory Affairs Veeva RIM Team by delegating projects, establishing and meeting timelines, and ensuring high quality work products., • Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees, and monitoring performance., • Manage dossier archiving and ensure regulatory data integrity, version control, and audit readiness., • Use Veeva RIM to upload and manage all regulatory submissions (e.g., BLA, IND, CTA), registrations, and archival of documents for both US and ex-US., • Upload, track, and maintain all correspondence with health authorities as well as ethic committees., • Partner with IT, Quality, and clinical on system support activities as needed., • Partner with IT, Quality, and clinical on system validation, upgrades, and testing, ensuring compliance with GxP and regulatory standards., • Ensure all regulatory questions, requests, and responses are accurately uploaded and linked properly in Veeva RIM., • Upload and maintain all Word and source documents in the Veeva Vault to enable version control, collaboration, and document updates., • Manage documents received but not limited to via regulatory gateways, emails, secure links., • Establish and maintain RIM-related SOPs, work instructions, and best practices., • Lead or support migration of regulatory and submission documents from legacy systems to Veeva., • Maintain full lifecycle document management: authoring, reviewing, approval, version control, metadata, retention., • Track regulatory submission, • Ensure all regulatory questions, requests, and responses are accurately uploaded and linked properly in Veeva RIM., • Upload and maintain all Word and source documents in the Veeva Vault to enable version control, collaboration, and document updates., • Manage documents received but not limited to via regulatory gateways, emails, secure links., • Establish and maintain RIM-related SOPs, work instructions, and best practices., • Lead or support migration of regulatory and submission documents from legacy systems to Veeva., • Maintain full lifecycle document management: authoring, reviewing, approval, version control, metadata, retention., • Track regulatory submission renewals, post-approval changes, and ensure timelines are met., • Monitor regulatory guidance and changes, perform impact assessment; communicate changes to cross-functional teams., • Ensure compliance with relevant regulatory requirements (FDA, EMA, ICH, local authorities), • Ensure that all working files and archives are organized and maintained in accordance with SOPs and Health Authority requirements, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications., • Provide user support/training for Veeva workflows; act as tool superuser., • Train and support cross-functional uses on Veeva RIM processes and document standards., • Prepare for internal/external audits, inspections, and data integrity assessments, address findings promptly., • Act as a point of contact for troubleshooting Veeva RIM issues and coordinating with system administrators., • Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 7+ years of regulatory operation experience in the biotech or pharmaceutical industry required; or, • High School diploma with 11+ years of regulatory operation experience in the biotech or pharmaceutical industry required., • Familiarity with global regulatory submissions (US and ex-US)., • 2 years of experience managing regulatory documentation using Veeva RIM required., • 2+ years of experience managing staff in support of Regulatory Affairs operations is preferred. Knowledge, Skills, & Abilities • Leadership skills with the ability to direct and develop professional staff, • Strong knowledge of Health Authority guidance documents and requirements., • Strong knowledge of Health Authority procedures and guidance regarding document management and electronic submission., • Strong knowledge of the use of Veeva RIM in document management., • Strong attention to detail and document management skills., • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities., • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $165,000 (entry-level qualifications) to $181,500 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Position: Manufacturing Associate Duration: 06 Months Location: Summit West, NJ, 07901 Breyanzi activation MO QUAD SCHEDULE: Quad 4 Alternating Wed & Thurs-Sat 5 pm - 5:30 am Training schedule: 4-6 weeks, ONSITE training (9 - 5, Mon - Fri) Description: Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. • Required Competencies: Knowledge/ Skills, and Abilities:, • Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique, • Knowledge of cGMP/FDA regulated industry, • Basic mathematical skills - General understanding of cGMPs, • Technical writing capability, • Proficient in MS Office applications, • Background to include an understanding of biology, chemistry, medical or clinical practices Pre-requisites: Entry- Level, • Duties and Responsibilities:, • Production of blood component lots through cell culture, harvest, and cryopreservation., • Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum., • Weighs and measures in-process materials to ensure proper quantities are added/removed., • Adheres to the production schedule ensuring on-time, internal production logistics., • Records production data and information in a clear, concise, format according to proper GDPs., • Works in a team based, cross-functional environment to complete production tasks required by shift schedule., • Motivated, team consciousness individuals are needed to fulfill job requirements., • Leads a team within a designated function of manufacturing, however, supervision will be managed by the shift Supervisor., • No direct reports will be assigned to this job role., • Performs other tasks as assigned., • Education and Experience: Bachelor's degree or Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience or High School diploma/GED and 4 years of Manufacturing or Operations experience Important Notes about working in the clean room: This position takes place in a GMP clean room environment, which includes being gowned for up to 6 hours. During the processing time in the clean room, no breaks may be taken Working Conditions: • Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. - Physical dexterity sufficient to use computers and documentation., • Sufficient vision and hearing capability to work in job environment., • Ability to lift up to 25 pounds., • Must have the ability to work around laboratories and controlled, enclosed, restricted areas., • Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet., • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas., • Flexibility to don clean room garments and personal protective equipment (PPE)., • Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected., • Routine exposure to human blood components.

Position: Manufacturing Associate Duration: 06 Months Location: Summit West, NJ, 07901 Breyanzi activation MO QUAD SCHEDULE: Manufacturing Associate Breyanzi - Shift 3 - Tue - Sat 9 PM - 5:30 AM Training schedule: 4-6 weeks, ONSITE training (9 - 5, Mon - Fri) Description: Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. • Required Competencies: Knowledge/ Skills, and Abilities:, • Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique, • Knowledge of cGMP/FDA regulated industry, • Basic mathematical skills - General understanding of cGMPs, • Technical writing capability, • Proficient in MS Office applications, • Background to include an understanding of biology, chemistry, medical or clinical practices Pre-requisites: Entry- Level, • Duties and Responsibilities:, • Production of blood component lots through cell culture, harvest, and cryopreservation., • Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum., • Weighs and measures in-process materials to ensure proper quantities are added/removed., • Adheres to the production schedule ensuring on-time, internal production logistics., • Records production data and information in a clear, concise, format according to proper GDPs., • Works in a team based, cross-functional environment to complete production tasks required by shift schedule., • Motivated, team consciousness individuals are needed to fulfill job requirements., • Leads a team within a designated function of manufacturing, however, supervision will be managed by the shift Supervisor., • No direct reports will be assigned to this job role., • Performs other tasks as assigned., • Education and Experience: Bachelor's degree or Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience or High School diploma/GED and 4 years of Manufacturing or Operations experience Important Notes about working in the clean room: This position takes place in a GMP clean room environment, which includes being gowned for up to 6 hours. During the processing time in the clean room, no breaks may be taken Working Conditions: • Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. - Physical dexterity sufficient to use computers and documentation., • Sufficient vision and hearing capability to work in job environment., • Ability to lift up to 25 pounds., • Must have the ability to work around laboratories and controlled, enclosed, restricted areas., • Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet., • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas., • Flexibility to don clean room garments and personal protective equipment (PPE)., • Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected., • Routine exposure to human blood components.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Support regulatory submission/publishing activities for eCTD global submission dossiers according to Agency and ICH Guidance requirements for major filings, (IND, NDA, sNDA, Amendments, DMFs, etc.) and regulatory maintenance activities. Support global submission timelines and coordination of publishing activities of work-related experience required for this position. Solid knowledge of submission requirements for regional markets may be required to ensure the overall submission and quality of the dossier meets regulatory compliance. Essential Functions Submission Management & Publishing Tasks: Manage assigned regulatory activity projects and closely collaborates with Senior Managers from GSM, Regulatory Affairs and other functional areas for the planning and publishing of regulatory submissions, monitoring submission forecast and ensuring timely high quality of regulatory submissions are submitted to health authority within required submission timelines. Publishing regulatory submissions (bookmarks, hypertext links, QC) scheduled to be submitted to regulatory agencies (e.g., FDA, EMA and Health Canada). Publishing Tasks: Assists with hands-on daily submission compilation and publishing activities associated with preparation of various dossier types Submission Specialist Tasks: • Responsible for publishing, review, submission compilation and archive for routine regulatory activities (e.g. Amendments) and complex eCTD submissions (e.g. IND, NDA)., • Uses internal and industry best practices in order to ensure quality submission deliverables., • Provide operational oversight to ensure timely, high quality regulatory submissions, • Participates in the development of optimal business processes (internal guides, SOPs, etc.) and practices within the department to ensure high levels of customer support and to achieve high quality submissions. Identifies and advises management with regards to opportunities for efficiencies, business process improvements, and cost reductions., • Position accountability/scope includes supervision of certain projects and assistance with priority setting required. Receives project assignments from manager, but has the responsibility for independently managing and executing own projects. Reviews project progress with manager on a regular basis with direction provided on follow-up., • Identifies opportunities and advises management for process improvements or cost savings. May participate on internal project teams in order to guide and update business processes., • Supports various document management assignments, including file transfer, archiving, tracking, and archival of Regulatory submission documentation (including SPL, FDA correspondence and submission)., • Demonstrates team leadership skills and ability to positively influence and work with others. Builds and maintains positive relationships internally and externally., • Participates in other key projects and activities as assigned by management to support the Regulatory Operations function including submission authoring and Regulatory Systems implementation projects. Publishing Tasks: Assist with hands-on daily submission compilation and publishing activities associated with preparation of various regulatory submission types. Applies good judgment and demonstrates initiative to resolve issues. • Expert understanding of Project Management tools and techniques., • Ensures publishing activities are processed in accordance with established SOPs., • Collaborate timeline with the regulatory affairs representatives, maintains the submission timelines, obtain status updates from the Publishing Manager and subteam members, RA Leads and reports submission status and activities to various stakeholders., • Update the regulatory submission calendar, and reports on key submission milestones to stakeholders, as applicable. Business Process Development & Problem Solving: • Participate and contribute to new and updated process and procedures. Review regulatory documents to ensure compliance with submission guidelines to drive efficient future state process including gaining buy in for key stakeholder and drive to standardization of processes., • Identifies risks and opportunities and addresses as needed with a focus on regulatory compliance requirements by supporting best practices, Working Procedures and SOPs., • Support process updates due to changing regulations that impact submission strategies and technologies, SEND, CDISC, Validator Software, etc. This includes not limited to identifying the validation checks needed to ensure compliance with eCTD Specifications for world-wide regulatory agencies., • May participate on internal project teams in order to guide and update business processes, as applicable. Regulatory Information Applications & Technology: • Support technology activities to ensure that regulatory information applications and systems are implemented, validated, and maintained in accordance with regulatory requirements compliance including but not limited to performing UAT scripts)., • Support Global System development and process development on a basic level, and process redesign., • Technical knowledge of the US and global regulatory requirements for electronic submissions Regulatory Training: Support and coordinate training to global submission management, regulatory publishing and other functional areas. Regulatory Submission Intelligence: Perform and collect regulatory information applicable to global electronic submissions guidance, publishing tasks, data standards, and technology and marketing trends in regulatory space. Ability to gather data, analyze research material information and communicate to management potential impact on regulatory operations strategies, and/or identify hot topic issues. Responsible for staying abreast of US, Harmonized (ICH) eCTD and Global guidances, and provide updates as required Requirements • Bachelor's Degree required, preferably in science or health related discipline, • Minimum 3-5 years pharma experience, including at least 1-2 years submission experience, • Experience regulatory professional that understands regulatory submission/ePublishing requirements for filing original applications, amendments, complex supplements/variations and line extensions, as well as routine submissions., • Excellent communication skills required to interact effectively with regulatory affairs members and regulatory colleagues in gathering the necessary information required for submissions, and to proactively address sensitive issues with diplomacy and tact., • Applies good judgment and demonstrates initiative to resolve issues., • Advance understanding of Submission Project Management tools and techniques., • Ensures submissions are processed in accordance with established SOPs., • Excellent analytical and problem solving skills: facilitating team(s) to identify issues and propose solutions with respect to regulatory eCTD submission issue, • Strong Communication Skills: Excellent verbal and written communication skills with demonstrated ability to present and articulate requirements with regulatory affairs members and regulatory colleagues proactively. Ability to foster and maintain relationships with strategic global regulatory organization and other functional partners to ensure understanding of current processes., • Project Management Skills: Strong project management skills with attention to detail, ability to work in a fast-paced environment while successfully prioritizing and working on multiple tasks while utilizing organizational skills., • Knowledge of Drug Development: Experience in regulatory operations or regulatory affairs with advanced knowledge of pharmaceutical development (e.g. CMC, Nonclinical, Clinical), • Technology & Software Skills: Advanced working knowledge of global eCTD publishing and Electronic Document Management technology, ISI Toolbox, Regulatory Tracking Systems (RTS) and related technology applications. Advanced user skill in MS Word, MS Sharepoint, Adobe Acrobat Professional, eCTD content templates and experience., • Teamwork Skills: Experience in working on teams and to establish effective relationships with team members., • Critical Thinking and Problem Solving Skills: Ability to track regulatory eCTD submission changes (e.g. regional DTD upgrade or system upgrades) and interpret potential implications for regulatory activities, training and/or timelines. Ability to identify the root cause of problems as well as the implications associated with potential solutions and communicate to management. Eisai Salary Transparency Language: The annual base salary range for the Senior Associate, Global Submission Management is from :$82,500-$108,300 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Job Summary: Reporting to the Director of Global Labeling, the Manager, Global Labeling is responsible for supporting Global Labeling Leads in daily operational labeling activities (US and global); managing and maintaining US SPL, drug listings, and establishment registrations; triaging, reviewing, and tracking Country Product Information (CPI); and performing operational activities that support Global Labeling deliverables and responsibilities. The primary responsibilities will be structured product labeling and maintaining drug listings. Essential Functions • Collaborate with key stakeholders to facilitate and lead cross-functional teams in the development, review, approval, and maintenance of the establishment registration and drug listing (bulk and finished) in the US., • Perform bi-annual review and submission of FDA-required drug listings and establishment registrations., • Act as a Subject Matter Expert (SME) on US Structured Product Labeling (SPL): Provide guidance and support for the U.S. drug listings and Structured Product Labeling (SPL), partner with an external service provider to deliver on SPL commitments., • Collaborate with global stakeholders and stay abreast of structured product labeling developments, requirements, and formats in rest of world, • Be familiar with National Drug Code (NDC), Dun and Bradstreet Number (DUNS), FDA Establishment Identification (FEI), and Global Trade Identification Number (GTIN) requirements, • Review and track requests for updates to Country Product Information (CPI) and CPI components. This includes QC, proofing, copy editing and formatting of documents, and coordinate review by Global Labeling Lead., • Attend necessary labeling team meetings to discuss decisions regarding any label and CPI updates, discuss any findings of meaningful differences among Source Reference Labels (SRLs) and CPIs., • Represent the Global Regulatory Services and Operations (GRSO), Global Labeling Group on project teams., • Support the use and development of current and new tools, technologies, and processes to support global label development, submission, approval, and dispatch of Source Reference Labels in and to respective countries in addition to global label support., • Track periodic CCDS reviews to ensure compliance with internal procedures and timelines., • Maintain labeling history documents and assist in responding to labeling-related queries from various functional areas., • Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained., • Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems., • Participate in and contribute to the continuous improvement efforts related to business practices and tools utilized within role., • Contribute and support the development and maintenance of job aids and guidance documents., • Support compliance activities including audits, inspections, and labeling-related escalations and non-conformances Requirements • BS degree (or higher) in life science, • A minimum of 4 years of experience in the pharmaceutical industry is required, • A minimum of 2 years of experience in product labeling/labeling regulations is required, • Can demonstrate strong project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral), attention to detail and ability to work under tight timelines, and across teams and regions, • Possess experience in both local and global regulatory labeling environments and work on multiple projects, • Must be a team-oriented individual with personal commitment to human relations, integrity, giving and receiving feedback, adaptability, and a diverse working environment, • Able to work under pressure and enforce company-wide standards, • Must possess a strong working knowledge of Microsoft Office applications, document management systems, labeling text verification systems as well as related labeling software and trackers Eisai Salary Transparency Language: The annual base salary range for the Manager, Global Labeling - Remote is from :$100,000-$131,300 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Director, Global Labeling is responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage labeling operations and actively contribute to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development. This job serves as an expert on regulations governing labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project teams to provide strategic input into the development and approval of Target Product Profile (TPP) for development products and all Eisai product Company Core Data Sheets (CCDSs), US Package Inserts (PIs), European Union (EU) Summary of Product Characteristics (SmPCs) and Emerging Market labels. This position manages a team of professionals located in the US and UK, and is responsible for employee-related activities, including resource management, performance management, coaching and mentoring on both operational and strategic aspects of labeling, and fostering a culture of proactive people development. Essential Functions • Lead cross-functional teams in the timely development of content for a new or revised CCDS, USPI, EU SmPC and Emerging Markets labels for assigned products, following internal procedures for review, approval and implementation of labels. Acts as liaison between co-promote partners and Eisai stakeholders in the labeling process., • Establish and maintain processes and standards for global labeling. Supervise direct reports to effectively operationalize labeling activities across all products. Develop and mentor direct reports on both operational and strategic aspects of labeling., • Responsible maintaining the Drug and Establishment Listings for all of Eisai's products., • Maintain centralized labeling repository within Eisai's electronic document management system for all global labels at various stages of development, review and approval. Manage labeling development, review and approval workflows within the electronic documents management system and track the timely and consistent implementation of safety changes in local labels., • Provide labeling support for Eisai US and EU Packaging Engineering functions for artwork control and approval., • Ensure consistency of labeling across product lines and compliance with Eisai policies and procedures and applicable regulatory authority directives and regulations. Analyze competitor labeling and ensure Eisai products have most competitive labeling., • Manage a team of professionals in the US and UK. Responsible for all employee-related activities throughout the year, including performance management and development., • Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities. Represent the Global Labeling group on Regulatory Sub-teams and other project teams to communicate key strategies. Requirements • Bachelors degree in life sciences required; higher degree preferred, • Minimum of 10 years of experience in Regulatory, R&D or related area, • Pharmaceutical experience required, • Solid working knowledge of drug development process, • Solid working knowledge and experience of global regulatory labeling environments and requirements, • Solid knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines., • Strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (written and oral), • Ability to work under tight timelines, • Attention to detail Eisai Salary Transparency Language: The annual base salary range for the Director, Global Labeling is from :$180,700-$237,200 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Job Locations US-NJ-Paramus ID 2026-1944 Category Regulatory Affairs Type Regular Full-Time A Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) Strategy is a leadership role within Regulatory Affairs responsible for the global regulatory strategy and execution related to the pharmaceutical quality and manufacturing of drug products. Strategic Leadership:Develop and execute global CMC regulatory strategies for products ranging from early-stage clinical development to post-approval lifecycle management. • Regulatory Submissions:Oversee the preparation and high-quality review of CMC components for major filings, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval supplements. Ensure CMC components in regulatory filings are scientifically sound, compliant, and aligned with ICH, FDA, EMA, and other global guidelines., • Health Authority Interactions:Serve as the primary point of contact for CMC-related negotiations with regulatory agencies, including leading formal meetings and responding to deficiency letters., • Cross-Functional Collaboration: Partner with Quality Assurance, CMC and Clinical Supply, R&D to ensure compliance with cGMP (current Good Manufacturing Practices) and assess the regulatory impact of CMC development plans and manufacturing changes., • Intelligence & Compliance:Monitor the evolving global regulatory landscape and communicate the impact of new guidelines (e.g., ICH guidelines) to senior leadership., • May be required to mentor and provide guidance to junior team members., • A bachelor's degree in a scientific field (Chemistry, Pharmacy, Biology, or Engineering) is required; an advanced degree (MS, PhD, or PharmD) is highly preferred., • Requires 10-15+ yearsin the pharmaceutical industry, with at least 8-10 years specifically focused on CMC regulatory affairs, • Deep expertise in eCTDsubmission formats, global regulatory requirements (US, EU, and Canada), and a proven track record of successful marketing application approvals., • Strong negotiation, conflict management, and the ability to influence cross-functional teams without direct authority., • Expertise with multiple dosage forms for small molecule drugs is preferred, • Experience with biologics is a plus., • Ability to travel up to 20% of the time domestically and internationally, • Experience working with Veeva

Principal/Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA/Canada Remote Based Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities *Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. *Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed. *Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk. *Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards. Provides training to members of the global medical writing team in aspects relative to their roles. *Serves as project lead for deliverables of assigned complex and/or large medical writing projects, including, but not limited to, scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring all information is distributed to the editorial team and implemented within the deliverable. *Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of editorial process. *Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices. *Performs quality review of assigned documents to ensure accuracy. *Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work. *Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget. *May compile medical writing deliverables. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $62,000.00 - $108,600.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with KOLs/HCPs, researchers, pharmacists, and decision makers in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of Alzheimer's disease (AD), including the needs, issues and priorities as they relate to Eisai's strategic medical plan. MSLs will be trained and certified on AD and Eisai's dementia pipeline data in order to fulfill educational gaps with KOLs/HCPs and gather medical insights to refine medical strategy and continue to close the gap on unmet educational needs for AD HCPs. MSLs also assume responsibility for special internal/external projects as they arise. The impact that a MSL will have on the organization includes the following: a) as a representative of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research, and c) provide corporate value through demonstrated leadership, teamwork, participation in strategic thinking, and special projects ESSENTIAL FUNCTIONS: Product/Therapeutic Area Support to Stakeholders • Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs in AD and dementia in which Eisai has current and future interests., • Present clinical and scientific data on Eisai's products and relevant therapeutic areas, as requested., • Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL activities., • Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs. Training/Education Resource • Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data, • Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives, • Serve as technical/scientific subject matter resource to Eisai cross functional partners, • Teach, coach and mentor new or less experienced MSLs; assist with supervision/performance evaluation; assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning., • Ability to lead and motivate team members without a direct reporting relationship Research Support • Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials., • The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies. REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (e.g MD/DO, PhD, PharmD) Experience: • 2-3 years MSL experience in neurology or complex disease states; prior dementia or AD research experience strongly preferred, 3 yrs+ required for Sr MSL title., • Established relationships with KOLs in neurology, and knowledge of institutions focused on AD preferred., • 3-5 years industry/ clinical research/ related experience in a scientific or clinical setting., • Strong broad-based scientific and pharmaceutical knowledge., • Clinical trial development and drug launch experience is strongly preferred, • Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are required., • Knowledge and experience within AD and ability to communicate with confidence and accuracy across multiple dementia disease states. Other Skills and Abilities: • Interested and skilled in communicating complex data sets and the ability to be seen as a scientific peer while educating top KOLs., • Committed to the concept of team and working within the framework of the Medical Affairs., • Strong overall written and verbal communication skills. Keen understanding of your audience and ability to tailor information appropriately., • Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt appropriately., • Demonstrated ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company and KOLs., • Has an ability to work independently and not require close supervision while adhering to compliance/regulatory policies., • Interest in leading and participating in projects while effectively balancing field work., • Demonstrated ability to proactively identify opportunities/challenges, willingness to communicate these challenges to leadership while working together to overcome them., • Seamlessly adapts to field situations and effectively problem solves within your territory., • Experience working in matrix environment including cross-functional commercial partners, with an understanding of the pharmaceutical corporate environment and appreciation for Commercial Operations, including Marketing and Sales strategies, • Sound computer/technology skills including applications for word processing, producing slide materials, working with spreadsheets, and video conferencing, • Possesses and maintains a valid driver's license and clean driving record., • Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends., • This is a field-based position. The employee is required to set up a home-based office within their defined territory. Salary range for MSL is $144,300.00 - $189,400 USD Annual Salary range for Sr. MSL is $160,100.00 - $210,100 USD Annual #LI-MI1 As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the MSL/Senior Medical Science Liaison, Neurology (Alzheimer's Disease) - Field Based, Northern and Central Florida - Field Based is from :$165,300-$216,900 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with KOLs/HCPs, researchers, pharmacists, and decision makers in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of Alzheimer's disease (AD), including the needs, issues and priorities as they relate to Eisai's strategic medical plan. MSLs will be trained and certified on AD and Eisai's dementia pipeline data in order to fulfill educational gaps with KOLs/HCPs and gather medical insights to refine medical strategy and continue to close the gap on unmet educational needs for AD HCPs. MSLs also assume responsibility for special internal/external projects as they arise. The impact that a MSL will have on the organization includes the following: a) as a representative of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research, and c) provide corporate value through demonstrated leadership, teamwork, participation in strategic thinking, and special projects ESSENTIAL FUNCTIONS: Product/Therapeutic Area Support to Stakeholders • Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs in AD and dementia in which Eisai has current and future interests., • Present clinical and scientific data on Eisai's products and relevant therapeutic areas, as requested., • Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL activities., • Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs. Training/Education Resource • Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data, • Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives, • Serve as technical/scientific subject matter resource to Eisai cross functional partners, • Teach, coach and mentor new or less experienced MSLs; assist with supervision/performance evaluation; assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning., • Ability to lead and motivate team members without a direct reporting relationship Research Support • Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials., • The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies. REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (e.g MD/DO, PhD, PharmD) Experience: • 2-3 years MSL experience in neurology or complex disease states; prior dementia or AD research experience strongly preferred, 3 yrs+ required for Sr MSL title., • Established relationships with KOLs in neurology, and knowledge of institutions focused on AD preferred., • 3-5 years industry/ clinical research/ related experience in a scientific or clinical setting., • Strong broad-based scientific and pharmaceutical knowledge., • Clinical trial development and drug launch experience is strongly preferred, • Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are required., • Knowledge and experience within AD and ability to communicate with confidence and accuracy across multiple dementia disease states. Other Skills and Abilities: • Interested and skilled in communicating complex data sets and the ability to be seen as a scientific peer while educating top KOLs., • Committed to the concept of team and working within the framework of the Medical Affairs., • Strong overall written and verbal communication skills. Keen understanding of your audience and ability to tailor information appropriately., • Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt appropriately., • Demonstrated ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company and KOLs., • Has an ability to work independently and not require close supervision while adhering to compliance/regulatory policies., • Interest in leading and participating in projects while effectively balancing field work., • Demonstrated ability to proactively identify opportunities/challenges, willingness to communicate these challenges to leadership while working together to overcome them., • Seamlessly adapts to field situations and effectively problem solves within your territory., • Experience working in matrix environment including cross-functional commercial partners, with an understanding of the pharmaceutical corporate environment and appreciation for Commercial Operations, including Marketing and Sales strategies, • Sound computer/technology skills including applications for word processing, producing slide materials, working with spreadsheets, and video conferencing, • Possesses and maintains a valid driver's license and clean driving record., • Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends., • This is a field-based position. The employee is required to set up a home-based office within their defined territory. Salary range for MSL is $144,300.00 - $189,400 USD Annual Salary range for Sr. MSL is $160,100.00 - $210,100 USD Annual #LI-MI1 As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL), Alzheimer's Disease (Northern CA) - Field Based is from :$160,100-$210,100 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Job Locations US ID 2026-1934 Category Medical Affairs Type Regular Full-Time Working closely with the Early Development Lead, the Senior/Executive Director of Clinical Development Oncology will lead clinical execution of targeted protein degradation (TPD) projects for SK Life Science Labs (SKLSL) with a dotted line into its sister company, SK Life Science Inc. (SKLSI). This role will provide strategic leadership across both preclinical and clinical development, ensuring seamless translation of discovery and preclinical findings into early- and late-stage clinical programs, with a particular focus on oncology. The incumbent will provide therapeutic and translational expertise to the development of the current TPD asset(s), while also contributing to portfolio and pipeline strategy. The role includes close partnership with discovery, preclinical, translational, CMC, regulatory, and clinical operations teams to enable efficient progression from IND-enabling activities through clinical proof-of-concept. The position reports to the Chief Scientific Officer of SK Life Science Labs with a dotted line to the Chief Medical Officer of SK Life Science Inc. Preclinical and Translational Development Provide clinical and translational leadership to preclinical oncology programs • Partner closely with discovery and preclinical teams to ensure alignment between biological rationale, nonclinical data packages, and clinical development plans, • Contribute to the design, interpretation, and integration of:, • In vitro and in vivo efficacy models, • PK/PD and biomarker strategies, • Translational endpoints to support dose selection and first-in-human studies, • Provide medical and scientific input into IND-enabling studies, including toxicology, safety pharmacology, and reproductive toxicology, • Support development of translational and biomarker strategies to enable early signal detection and patient selection in oncology trials, • Participate in the development of integrated product development plans and clinical trial strategies informed by preclinical and translational data, • Lead the design and conduct of clinical trials and, as a member of the internal SK Life Science Inc. Clinical Development/Medical Affairs team, provide operational oversight by collaborating with internal and external operations personnel, • Provide medical expertise regarding product development or other scientific issues for drug discovery, development, and senior management decision-making, • Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials, • Participate in pharmacovigilance activities, including SAE evaluation, safety signal assessment, and ongoing analysis of safety data, • Participate in preparation and review of protocols, Investigator Brochures, clinical study reports, safety reports, and clinical sections of Annual Reports, INDs/IMPDs, NDAs/MAAs, SOPs, pediatric investigation plans, as well as abstracts and manuscripts, • Interface with regulatory agencies for clinical development programs and regulatory submissions as needed, • Oversee scientific interactions with medical consultants, advisors, and clinical investigators, • Training in and adherence to Good Clinical Practices (GCP); working knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) as they relate to preclinical and clinical development, • Knowledge of relevant global regulatory guidance impacting preclinical, translational, and clinical development, • Experience interacting with FDA and other global health authorities preferred, • Evidence of ability to work with opinion leaders, • Must be able to work effectively in a team setting, • Communication skills necessary to:, • Represent the Company externally in scientific presentations, conferences and industry groups;, • Present to internal stakeholders; Interact with industry, • M.D. degree with specialized training in oncology preferred, • Practice experience preferable but not required, • Minimum of 10 years of experience in clinical development in the pharmaceutical industry, preferably with oncology compounds or relevant academic research experience, • Ability to multitask, • Adapts to change, • Maintain composure under pressure, • Ability to follow verbal or written instructions and use of effective verbal communications, • Adapts change, adjust change and grasps information quickly, • Examine and observe details

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Job Profile Summary The Associate Director, Medical Information Oncology, is responsible for leading and driving Global & US Medical Information activities for assigned therapeutic area(s) to meet the Eisai product information needs of external customers and internal business partners. This role is seen and sought after for their subject matter expertise in Oncology and assigned therapeutic area(s) and serves as medical reviewer of Eisai's advertising, promotional, and scientific exchange materials as part of Copy Review Committee and Medical Review Committee. Beyond traditional responsibilities, this position offers a unique opportunity to optimize and communicate medical information insights as part of a broad, cross-functional strategic team, ensuring these insights inform decision-making and drive innovation across the organization. The Associate Director will also leverage and implement AI-driven tools and capabilities in new and transformative ways, enhancing efficiency, personalization, and scalability of medical information services. The AD, Medical Information contributes to the development and implementation of medical plans, including the creation of standard medical responses, development of AMCP dossiers, compendia submissions, and other medical information deliverables. This role is also responsible for oversight or management of Medical Information Specialists/Managers, budget management of assigned activities, contributing to performance improvement activities, conducting quality monitoring, tracking and reporting of medical information insights and metrics, ensuring regulatory compliance, inspection readiness, and appropriate documentation and reporting of product incident reports. Responsibilities (Expanded) * Develop and manage tactical execution of the Medical Information component of Global & US Medical Affairs strategic plans for assigned therapeutic area(s). * Develop and ensure high-quality, balanced, and scientifically accurate documents in response to medical inquiries from external customers and internal stakeholders; conduct quality assurance measures and handle escalated inquiries as needed. * Lead and drive the development of Medical Information deliverables, including research and analysis of the scientific literature, standard medical responses (SMRs), verbal responses to FAQs, AMCP dossiers, compendium and pathways submissions, etc. * Serve as medical reviewer, ensuring medical accuracy and provision of feedback for Eisai's advertising, promotional, and medical materials as part of Copy Review Committee and Medical Review Committee. * Lead and provide oversight of department reporting processes, KPIs, insights analytics, digital analytics, and other trend reports that are shared with internal stakeholders; proactively identify opportunities to optimize insights for strategic decision-making. * Explore and implement AI-driven tools and technologies to enhance medical information processes, improve efficiency, and deliver innovative solutions for internal and external stakeholders. * Liaise with global and regional medical affairs colleagues as appropriate. * Provide strong scientific support for conference and booth coverage. * Implement and participate in department training, process and performance improvement activities, quality monitoring, metrics tracking, regulatory compliance, inspection readiness, and product incident response. * Serve as a business partner to internal and external collaborators as needed to support scientific exchange activities and address critical escalations as warranted. * Provide mentoring, guidance, and training to new hires/less experienced colleagues. * May provide direct supervision of Medical Information Sr Managers, Specialists, and contractors, as appropriate. * Travel required up to 30% of time. * Hybrid based in Nutley, NJ (in office Tuesday, Wednesday and Thursday) Qualifications: * Advanced degree in sciences or related field with 10+ years of experience in the pharma/biotech industry OR a combination of equivalent education and experience. * Strong scientific knowledge and expertise in Oncology, including evaluating and communicating clinical trial and disease state information to a wide range of audiences. * Demonstrated experience in conducting scientific literature review, and management of medical inquiries, including the development and review of medical information deliverables (e.g., standard medical response documents, FAQs, dossier, compendium submissions, etc.) * Practical experience and knowledge of FDA guidance on appropriate scientific exchange practices. * Previous experience of managing/leading teams directly/indirectly or coaching and mentoring new hires/less experienced colleagues. * Proficiency with Microsoft Office Suite software, SharePoint, Veeva, customer relationship management software, and other technology and telephony systems. Additional Preferred Qualifications: * Experience with AI tools, digital innovation, and data analytics to enhance medical information processes and insights. * Ability to identify and implement emerging technologies to optimize workflows and deliver innovative solutions. * Strong understanding of data visualization and insights reporting to support strategic decision-making. Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Healthcare Environment Dynamics, Inquiry Resolution, Literature Evaluation, Medical Information Writing Skills, Medical Review, Mentoring/ People Development, Resource Planning & Management Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Medical Information, Oncology is from :$164,600-$216,100 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Experienced Clinical Research Associate - Full-Service - Ophthalmology Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution., • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills, • Ability to manage required travel of up to 75% on a regular basis, • US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Job Summary: The Manager, Graphics Design is a self-directed contributor responsible for design and development of pharmaceutical product labeling artwork for primary and secondary packaging of pharmaceutical products, package inserts, and trade labeling. These activities support proposed, new, and existing commercial products. This position demonstrates high level performance and delivers high quality labeling artwork design for product packaging on schedule to meet patient, company, and regulatory needs. This position is responsible for development of, and company adherence to, cGMP compliant prescription pharmaceutical labeling artwork control and approval systems and procedures. This position requires continuous collaboration with multiple internal Eisai departments, Global Regulatory Affiliates, and Corporate Alliance Partners to assess labeling artwork needs and provide quality, compliant product labeling artwork for global product distribution. This position is responsible for security and control of Eisai Raleigh managed product labeling artwork files and electronic labeling artwork file systems. This position manages the graphic design contract service providers as needed to support high volume, critical path projects. The Manager, Graphic Design is a self-directed SME for labeling artwork management and control systems. This position determines how best to manage multiple projects and tasks to meet challenging, shifting timelines to support Eisai products packaged and/ or launched at external sites. Extensive industry experience and independent decision making is necessary to define, facilitate and/or customize cGMP compliant pharmaceutical labeling artwork procedures and systems to manage ethical drug product labeling requirements for US and ROW country specific product packaging within project specific labeling formats that involve multiple levels of complexity. Responsible for management of contract service providers (proofreaders and back-up graphic designer ) any additional graphics service providers that may be needed to support trade labeling. The Manager, Graphic Design stays abreast of and conversant in current pharmaceutical labeling artwork trends, requirements, best practices, and new technology relevant to product labeling. Collaborates with other functional groups within the company and maintains membership in industry-related packaging organizations such as IOPP/PmDLC to understand industry trends and best practices. May participate in industry group meetings, forums and cross-company benchmarking efforts. Essential Functions: • Creation, development and control of pharmaceutical labeling artwork for contractor-packaged prescription drug products. Collaborates directly with Supply Operations, Contract Manufacturing Operations (CMOs), multiple external contract packaging sites, country specific Global Regulatory Affiliates, Marketing, Technical Operations, Quality Assurance, and Corporate Alliance Partners to provide high quality, regulatory compliant labeling artwork for commercial products managed by Eisai Raleigh site., • Facilitates communication between cross-functional teams to support end-to-end labeling and timely implementation of regulatory updates., • Provides pharmaceutical product labeling artwork to meet critical path deadlines for new US and ROW product launches and / or submissions to the FDA and other country specific regulatory authorities, to facilitate global product launch initiatives., • Collaborates with Technical Operations during development of new packaging components for launch or line changes and develops test component artwork to support package line initiatives., • Strengthens and maintains cGMP compliant procedures for prescription pharmaceutical labeling artwork control and approval. Collaborates with management of affected departments to ensure cohesive working relationships and to meet shared objectives., • Management of contract service providers for support of labeling artwork procedures & systems to maintain and control current and retired FDA approved labeling artwork files., • Management of contract design services as needed to support high volume critical path projects. Requirements: • Bachelor's degree in graphic design, • 1-year related work experience in the pharmaceutical industry., • High skill level and understanding of design programs on Macintosh platform. Direct experience with Adobe Creative Cloud required., • Knowledge and experience with labeling security and serialization features., • Understanding of and direct experience with cGMP and FDA Regulatory prescription pharmaceutical labeling requirements., • Understanding of and direct experience with ROW, Canada, and emerging market country-specific labeling artwork requirements., • Ability to work independently and effectively, prioritizing assignments without supervision., • Highly developed interpersonal skills are required to effectively deal with all levels of personnel from executives to non-exempt and outside vendors., • Ability to exercise independent judgment and initiative on labeling matters., • Demonstrated initiative, results oriented, willingness and ability to institute change., • Process oriented with a strong interest in continuous improvement. #LI-MI1 Eisai Salary Transparency Language: The annual base salary range for the Manager, Graphics Design - Remote is from :$102,300-$134,300 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

About Us United Premium Foods is an equal opportunity employer who wishes to hire highly motivated individuals to join our team working in our food production and cold storage facility. We are a manufacturer of superior quality food (protein-based) products dedicated to delivering exceptional food processing solutions that prioritize safety, quality, and superior customer service. Our commitment to excellence is reflected in our rigorous processes we maintain to meet the highest safety and food safety standards, and in our New Jersey facility, which is USDA and FDA Level 2 certified. About the Role We are seeking an experienced, detail-oriented and results driven Supply Chain Manager to drive and optimize end-to-end supply chain operations at our fast-growing food manufacturing company. The ideal candidate should have strong leadership capabilities, meticulous organizational skills, excellent communication and collaboration prowess, deep expertise in supply chain processes, and a proven track record in the food industry. Roles & Responsibilities A Supply Chain Manager (SCM) oversees and optimizes the flow of production materials, information, and finished products from suppliers to customers. The SCM is responsible for balancing quality, costs, and delivery while also effectively managing end-to-end movement of goods throughout the entire production process. Key duties include ensuring timely procurement and delivery of raw materials, collaborating production schedules, maintaining accurate inventory, securing cost-effective logistics, and enforcing strict compliance with food safety regulations. The SCM must also ensure products are delivered on-time and in-full while monitoring various KPIs and adhering to the highest standards of quality. Additionally, SCM needs to anticipate and manage risks while balancing competing priorities to keep the supply chain resilient and effective. • Strategic Planning & Execution, • Develop and implement supply chain strategies aligned with business goals., • Forecast demand and plan inventory to meet production and customer needs., • Establish and monitor KPIs, • Manage and utilize ERP / MRP system, • Procurement & Vendor Management, • Source and negotiate with suppliers for raw materials, packaging, and services., • Build and maintain strong relationships with vendors to ensure quality and reliability., • Production & Inventory Control, • Collaborate with production teams to align supply with manufacturing schedules., • Monitor inventory levels, reduce waste, and ensure optimal stock management., • Logistics & Distribution, • Oversee transportation, warehousing, and distribution of finished goods., • Ensure timely delivery to customers while minimizing costs., • Compliance & Quality Assurance of materials, • Ensure adherence to food safety standards (FDA, USDA, HACCP, GMP)., • Maintain compliance with regulatory requirements and company policies., • Team Leadership - lead, mentor, and develop supply chain team., • Foster a culture of continuous improvement and operational excellence. Qualifications • Bachelor’s degree in Supply Chain Management, Business Administration, or related field (Master’s preferred)., • 5+ years of experience in supply chain management, preferably in food manufacturing., • Strong knowledge of ERP systems and supply chain software., • Excellent negotiation, communication, and leadership skills., • Deep understanding of food safety regulations and compliance standards., • Excellent leadership, communication, and negotiation abilities. Soft Skills • Lean manufacturing and Six Sigma certification., • Experience with sustainability initiatives in food supply chains., • Ability to thrive in a fast-paced, dynamic environment., • Strong analytical and problem-solving skills with a detail-oriented approach., • Adaptability and resilience in a fast-paced environment with potential disruptions., • Bi-lingual in English & Spanish is a plus. Working Conditions • Food manufacturing environment and cold storage warehouse. Ability to commute/relocate: • Woodbridge, NJ 07095: Reliably commute or relocate before starting work (Required).

The Overnight Assistant Distribution Center Director at John F. Kennedy Distribution Center is responsible for supporting the Distribution Center Director with managing overall distribution center activities for offsite operations with $400+ million in revenue accountability serving multiple airport locations. This role involves assisting with distribution center personnel leadership, vendor relationships, inventory management across multiple locations, regulatory compliance support, and coordinating operations across multiple lines of business including retail, restaurants, and duty-free shops while ensuring operational efficiency and accuracy. Essential Functions • Assist in managing inventory accuracy, including transportation of orders and returns to multiple locations, product rotation, temperature control procedures, and reverse logistics using SAP, CrunchTime, and distribution management systems., • Supervise day-to-day distribution center activities, including staff scheduling, shift coverage, and operational continuity while providing service to multiple airport locations for receiving, processing, and distributing merchandise for retail and food & beverage operations., • Support vendor relationship management to ensure proper stock levels that support sales objectives across served locations. Assist with coordinating distribution operations across retail, restaurants, and duty-free shops while helping resolve delivery issues, shortages, and quality concerns., • Assist with monitoring and reporting key performance indicators (KPIs) including inbound throughput, labor efficiency, and operational metrics across multiple locations. Support the implementation of contingency plans for distribution center operations., • Support compliance with U.S. Customs, FDA, and other regulatory bodies, and assist with maintaining accurate records, particularly for bonded merchandise., • Assist with enforcing food safety protocols, including FIFO stock rotation, expiration date monitoring, and overall food safety compliance. Participate in Quality Assurance activities and maintain security of food storage areas., • Support the training, coaching, and development of distribution center staff while assisting with performance management in accordance with company policies and union agreements where applicable., • Maintain distribution center organization, including fixtures, equipment storage, bin locations, and physical inventory processes. Review incoming orders from multiple locations and ensure accurate data entry into systems., • Assist with communication and collaboration with airport management teams across served locations to support operational goals while coordinating between associates and management teams., • Operate company vehicles safely and maintain compliance with all transportation and safety requirements for multi-location distribution operations. Reporting Relationship & Role Information • This position typically reports to the Distribution Center Director within the assigned distribution center location., • The Assistant Distribution Center Director position falls under the Fair Labor Standards Act (FLSA) as an Exempt position., • Requires scheduling flexibility to work various shifts including days, evenings, nights, weekends, and holidays as operational needs require., • Must be able to pass government background checks where required for working in a Customs Bonded Warehouse. Physical Requirements • Ability to walk extensively throughout distribution centers and coordinate with multiple airport locations for extended periods., • Lift, carry, and move inventory items up to 50 pounds regularly., • Visual acuity to review inventory records, conduct physical counts, and analyze data reports., • Ability to work in varying warehouse and retail environments with different temperature and noise levels. Minimum Qualifications, Knowledge, Skills, and Work Environment Education & Experience The combination of education and professional experience must exceed 5 years: • Minimum 2 years of supervisory experience leading distribution center, supply chain, and/or logistics teams serving multiple locations. Experience managing in a unionized environment (CBA) preferred., • In a technical role: 5 years of experience in distribution operations, inventory management, or supply chain coordination with multi-location responsibility., • High school diploma or GED required. A Bachelor’s degree in Business Administration, Supply Chain Management, Operations Management, or a related program may count toward 2 years of the experience requirement., • Minimum 2 years of driving experience with a valid state driver's license. Specialized Training • Basic understanding of food safety protocols and HACCP principles preferred., • Training that leads to an understanding of U.S. Customs and FDA regulatory compliance requirements preferred., • Experience with distribution and warehouse management systems (SAP, CrunchTime preferred)., • OSHA safety and hazardous material handling awareness. Specialized Skills, Competencies & Traits • Excellent time management and prioritization skills, with the ability to support multiple concurrent distribution operations across locations while maintaining accuracy in inventory tracking and data entry., • Valid driver’s license with a clean driving record and the ability to operate commercial vehicles and heavy distribution equipment safely. CDL or commercial truck driving experience preferred but not required, particularly in urban locations., • Proficiency in Microsoft Office Suite, including intermediate Excel for reporting, and the ability to quickly learn distribution management systems such as SAP and CrunchTime., • Strong verbal and written communication skills, with the ability to effectively communicate with multiple airport locations, vendors, team members, and management while reading and comprehending technical instructions and policy documents., • Strong problem-solving abilities to resolve operational issues across multiple locations and escalate complex matters appropriately., • Demonstrated ability to understand the needs of multiple business locations, stakeholders, and employee populations, including individual circumstances., • Proven history of creating and maintaining positive work environments. Disclaimer: All job requirements are subject to change to reflect the evolving position requirements or to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a threat or risk to the health and safety of themselves or other employees. This job description in no way states or implies that these are the only duties to which will be required in this position. Employees will be required to follow other job-related duties as requested by their supervisor/manager (within guidelines and compliance with Federal and State Laws). Continued employment remains on an "at-will" basis. Dufry, Hudson, and HMSHost are equal opportunity employers and do not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factors.

Job Title: Customs Entry Writer Job Summary: We are seeking a detail-oriented Customs Entry Writer to join our logistics team. This role is responsible for preparing and submitting import documentation to U.S. Customs and Border Protection (CBP) to ensure timely clearance of international shipments. The ideal candidate will have experience in customs brokerage or freight forwarding, strong knowledge of import regulations, and the ability to manage multiple shipments in a fast-paced environment. Key Responsibilities: • Prepare and submit customs entries through ABI in accordance with CBP regulations, • Review commercial invoices, packing lists, bills of lading, and other import documents for accuracy and compliance, • Classify imported goods using the Harmonized Tariff Schedule (HTS) and determine applicable duties, taxes, and fees, • Communicate with importers, freight forwarders, carriers, and government agencies to obtain required documentation and resolve entry issues, • Monitor shipment status and coordinate cargo release with CBP and other regulatory agencies (FDA, USDA, EPA, etc. when applicable), • Maintain accurate records of import transactions and ensure compliance with company and government regulations, • Research and resolve customs holds, exams, and documentation discrepancies, • 2+ years of experience in customs brokerage, freight forwarding, or import operations, • Knowledge of U.S. Customs regulations and the Harmonized Tariff Schedule (HTS), • Experience filing entries through ABI and working with customs brokerage software, • Strong attention to detail and ability to manage high-volume entry processing, • Excellent communication and organizational skills, • Proficiency in Microsoft Office, especially Excel

Position: Manufacturing Associate Duration: 06 Months Location: Summit West, NJ, 07901 Breyanzi MO Associate Quad 2 (Sun - Tue & alternating Wed 5 pm - 5:30 am) Training schedule: 4-6 weeks, ONSITE training (9 - 5, Mon - Fri) Description: Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. • Required Competencies: Knowledge/ Skills, and Abilities:, • Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique, • Knowledge of cGMP/FDA regulated industry, • Basic mathematical skills - General understanding of cGMPs, • Technical writing capability, • Proficient in MS Office applications, • Background to include an understanding of biology, chemistry, medical or clinical practices Pre-requisites: Entry- Level, • Duties and Responsibilities:, • Production of blood component lots through cell culture, harvest, and cryopreservation., • Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum., • Weighs and measures in-process materials to ensure proper quantities are added/removed., • Adheres to the production schedule ensuring on-time, internal production logistics., • Records production data and information in a clear, concise, format according to proper GDPs., • Works in a team based, cross-functional environment to complete production tasks required by shift schedule., • Motivated, team consciousness individuals are needed to fulfill job requirements., • Leads a team within a designated function of manufacturing, however, supervision will be managed by the shift Supervisor., • No direct reports will be assigned to this job role., • Performs other tasks as assigned., • Education and Experience: Bachelor's degree or Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience or High School diploma/GED and 4 years of Manufacturing or Operations experience Important Notes about working in the clean room: This position takes place in a GMP clean room environment, which includes being gowned for up to 6 hours. During the processing time in the clean room, no breaks may be taken Working Conditions: • Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. - Physical dexterity sufficient to use computers and documentation., • Sufficient vision and hearing capability to work in job environment., • Ability to lift up to 25 pounds., • Must have the ability to work around laboratories and controlled, enclosed, restricted areas., • Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet., • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas., • Flexibility to don clean room garments and personal protective equipment (PPE)., • Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected., • Routine exposure to human blood components.

We are seeking a detail-oriented Account Representative - Customs Brokerage (Entry Writer) to support daily international logistics operations in Franklin Square. This role is responsible for coordinating and executing shipments while ensuring compliance with U.S. Customs and other government agencies. You will serve as a key liaison between customers, internal teams, and regulatory bodies to ensure timely and accurate clearance of goods into the United States. • Act as the primary customer service liaison between the company and clients, • Process U.S. Customs entries and Other Government Agency (OGA) filings, • Open and manage shipment files in CargoWise and/or AS400 systems, • Classify commercial invoices using HTS (Harmonized Tariff Schedule), • Ensure compliance with U.S. regulatory agencies (FDA, EPA, FCC, Fish & Wildlife, etc.), • Communicate with internal departments, carriers, vendors, and government agencies, • Coordinate shipments with airlines, ocean carriers, forwarders, and agents, • Track and trace shipments, providing updates and resolving issues, • Convert and verify shipment weights, volumes, and foreign currencies, • Maintain accurate documentation and filing systems, • Assist customers with inquiries, complaints, and shipment updates, • Handle accounting-related processes accurately and on time, • Review and prepare documentation to meet regulatory and carrier requirements, • Minimum 3 years of customs brokerage experience (or equivalent combination of education and experience), • Strong knowledge of U.S. Customs regulations and OGA requirements, • Experience with freight clearance processes Ready to make an immediate impact? Apply now! What We Offer: Hunter Hamilton offers comprehensive benefits packages (medical, dental, vision, long and short-term disability, 401k, etc.). We strive to deliver genuine support throughout the duration of the recruiting process, through the length of the assignment, and beyond! The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs. Hunter Hamilton is a high-performance professional search firm specializing connecting finance, HR, operations, and legal talent with leading employers. Hunter Hamilton is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Hunter Hamilton offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Hunter Hamilton is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at . By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Regulatory Affairs Program Manager leads crossfunctional regulatory projects from strategy through execution, ensuring that all products meet global regulatory requirements and are launched on schedule. This role partners closely with R&D, Clinical, Quality, Manufacturing, and Commercial teams to develop and implement regulatory strategies, manage submission timelines, and drive successful product approvals worldwide. Essential Functions • Design, plan, and manage cross-functional and ongoing regulatory programs, defining schedules, milestones, deliverables, resources, and risk-mitigation strategies., • Function as a Regulatory Affairs point of contact for internal teams, translating regulatory requirements into clear and actionable objectives., • Coordinate crossfunctional project teams, ensuring alignment with regulatory objectives and strategy. Track and report program status to senior leadership and external partners., • Conduct regulatory intelligence to anticipate changes in laws, guidance, and standards. Assess impact on products/processes and communicate findings., • Identify risks early, develop mitigation plans, and resolve issues that could impact timelines or approvals., • Foster a culture of continuous improvement and regulatory excellence., • Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates., • Performs ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's degree in sciences, business, project management or a related field with 7+ years of relevant progressive experience is required., • 5+years of regulatory affairs experience in the pharmaceutical, biologics, or medical device industry is preferred., • 3+years managing complex, multiregional regulatory programs is preferred. Knowledge, Skills, & Abilities • Understanding and knowledge of FDA and other major healthauthority requirements, a plus., • Proven ability to work with crossfunctional teams, manage budgets, and deliver on schedule., • Excellent written and oral communication skills., • Strong analytical and problemsolving abilities., • Proficiency with MS Office suites and project management tools. Working Environment / Physical Environment • This position works on-site, • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer., • Lift and carry materials weighing up to 30 pounds. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $141,300 (entry-level qualifications) to $157,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.