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Job Description Job Description Date 10/2025 Location 22 Van Dyke Avenue, New Brunswick NJ 08901 / 1300 Airport Road, North Brunswick NJ 08902 Title Operator, Dispensing Department Dispensing Reports to Manager, Dispensing FLSA (Exempt or Non-Exempt) Non-Exempt Role Overview The Dispensing Operator will perform all functions related to dispensing of material, receipt of goods, put-away material into warehouse aisles, pull out material per Batch card/Pick ticket, put back to same location from where it was pulled for batches, manual order processing, order auditing, shipment preparation, pallet building, transferring material from wood to plastic pallets, and cycle counting inventory. All functions may require the use of powered industrial trucks, Syspro or RF as needed. Will need to work in temperature-controlled areas. Areas of Responsibility Level 1: Dispensing Operator Overview: This is a training-level role for individuals with limited or no prior experience in pharmaceutical dispensing. Works under close supervision while learning company SOPs, GMP standards, and equipment operations. Key Responsibilities: • Assist in pulling and weighing raw materials under supervision., • Learn to read and interpret batch cards and pick slips., • Calibrate scales before use., • Cleans room after batch is complete, • Ensures safety and quality standards are consistently followed., • Maintain basic cleanliness of work area and equipment., • Support warehouse duties such as material receipt and basic inventory handling., • Follow safety procedures and learn PPE protocols., • Operate pallet jacks or assist with forklift activities (if certified). Level 2: Dispensing Operator Overview: This level is for operators with hands-on experience in pharmaceutical or supplement dispensing. Operators are responsible for completing batch-related activities with minimal supervision and maintaining documentation compliance. Key Responsibilities: • Dispense raw materials independently per batch cards., • Reviews batch card. Determine material to be used in the batch. Pull out material per requirement and enter in logbooks., • Performs requests received from other departments such as R&D, Production, QA or Purchasing etc., • Cleans room after batch is complete, • Ensures safety and quality standards are consistently followed., • Weigh materials accurately and calibrate scales before use., • Use Syspro or RF systems for inventory control., • Handle, put-away, return, and transfer of goods between warehouse locations., • Perform manual order processing, auditing, and preparation for shipments., • Maintain gowning and hygiene protocols in controlled environments., • Ensure accurate documentation in logs and batch records. Level 3: Dispensing Operator Overview: A highly experienced operator who may act as a team lead or trainer. Oversees batch dispensing activities, ensures compliance, and supports continuous improvement initiatives. Key Responsibilities: • Lead batch dispensing operations; verify materials and documentation., • Train and mentor entry and intermediate-level operators., • Collaborate with cross-functional teams (QA, R&D, Production)., • Reviews batch card. Determine material to be used in the batch. Pull out material per requirement and enter in logbooks., • Performs requests received from other departments such as R&D, Production, QA or Purchasing etc., • Cleans room after batch is complete, • Ensures safety and quality standards are consistently followed., • Conduct cycle counts and helps manage inventory accuracy., • Troubleshoot equipment or material issues; escalate when necessary., • Lead compliance audits for dispensing areas., • Support continuous improvement, safety, and 5S initiatives. Physical & Environmental Requirements (All Levels): • Able to lift 55 lbs regularly; occasionally up to 75 lbs., • Stand/walk for 6+ hours per shift., • Work in temperature-controlled rooms with PPE (lab coat, gloves, face mask, respirator, etc.)., • Exposure to dust, noise, and cleaning agents. Bottom of Form Requirements Education & Qualification: Level 1: Dispensing Operator • High school diploma or GED., • 0–1 year of experience in manufacturing or warehouse setting., • Basic math and English reading skills., • Willingness to learn cGMP, OSHA, and SOPs. Level 2: Dispensing Operator • High school diploma or GED., • 2+ years of experience in a pharmaceutical production environment., • Forklift operation experience (certification preferred)., • Familiarity with cGMP and SOP documentation standards., • Attention to detail and ability to troubleshoot basic dispensing issues. Level 3: Dispensing Operator Requirements: • High school diploma or GED; technical certification a plus., • 4+ years of dispensing experience in a GMP-regulated and within a pharmaceutical production environment, • Strong understanding of regulatory compliance (FDA, GMP, OSHA)., • Proven ability to lead teams and communicate effectively., • Proficient in inventory software (Syspro or similar ERP systems)., • Additional experience in granulation, compression, or blending is a strong plus. Certifications, Licenses, Credentials: • Prior certification to operate a sit-down forklift is a plus. Skills & Ability • Demonstrates ability to work in a team and assist others., • Able to follow written instructions precisely and perform basic math calculations as required., • Understands and is knowledgeable of cGMP, OSHA standards, etc., • Mechanically inclined to understand the inner workings of the equipment., • Demonstrates the ability to read and write basic English to be able to understand the industry-regulated instruction sheets., • Must have attention to detail. Physical Requirements (lifting, etc.): • Ability to lift up to 55 lbs.; occasionally lift and move up to 75 pounds., • Must stand and walk on the production floor for a minimum of 6 hours per shift, • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances., • Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment., • Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment 1st shift - 7:00 am to 3:30 pm

Position Summary: The Packaging Operator is responsible for operating packaging line equipment, handling materials, and ensuring compliance with safety, quality, and regulatory standards. This role requires attention to detail, adherence to SOPs, and effective communication to maintain smooth and efficient packaging operations. Education Required High School Diploma or Equivalent Required Experience Required: 1-2 years’ experience in FDA regulated packaging environment desired. Specialized or Technical Knowledge, Licenses, Certifications required Proficient in navigating HMI screens for various packaging equipment, including Tablet/Capsule Filler, Cottoner, Capper, Desiccant Inserter, Checkweigher, Labeler, Case Former, and Pallet Jack. Ability to assist Packaging Technicians during line changeovers. Capable of working extended hours and maintaining focus under challenging conditions.

Job Summary: A hands-on scientific position evaluating, designing, and executing robust scaleable formulation development plans. The position will focus on enabling delivery and absorption of drugs and complex molecules via oral, transdermal, and topical routes. Also, the position will function as a key member of the team responsible for evaluation and execution of study plans to drive the development of new or alternative technologies and innovations. Responsibilities: Responsible for design, execution, and analysis of formulation strategies in support of product development, product characterization and process optimization relating to Aquestive’s pharmaceutical business. Designs and optimizes formulations to achieve drug product properties for controlled delivery of drugs (i.e. oral, transmucosal, and topical) . Designs, prepares, and characterizes laboratory prototype samples for in vitro, ex-vivo, and in vivo evaluation. Evaluates and vets new and emerging technologies to drive innovative drug delivery. Serves as an Aquestive SME for new product/technology opportunities, collaborating cross-functionally with internal and external stakeholders. Responsible for developing robust formulations and processing conditions for the successful scale up to commercial equipment. Authors and executes manufacturing batch records for GMP manufacture of Phase I clinical supplies. Authors technical reports and procedures for experimental studies and in support of regulatory activities. Provides technical support for technology transfer, CMC documentation, and manufacturing readiness. Mentors junior scientists in formulation techniques, experimental design, and data analysis. Maintains rigorous scientific practices, data integrity, and laboratory compliance within internal standards. Performs other duties as deemed necessary to support laboratory operations. Qualifications: MS or PhD (preferred) degree in a relevant scientific discipline with 5-10 years' experience in pharmaceutical development. Experience in alternate delivery of drugs (oral, transmucosal, topical) preferred Strong background in formulation design, optimization, and characterization Hands-on expertise with experimental design, data analysis, and statistical tools. Excellent technical writing skills for preparing reports and presentations. Good understanding of formulation development principles, DoE/QbD and FDA/CMC/ICH guidelines are required Regulatory document authoring experience is required Must have an ability to work on multidisciplinary teams to drive innovation that leads to commercially viable products/technologies. Proficiency in standard office software (MS Word, Excel, PowerPoint) and statistical analysis tools (i.e. JMP). Must be detail oriented, organized, and suited to work in a dynamic fast-paced environment. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $115,000.00 to $125,000.00 USD

Chemist II – FDA cGMP Analytical Lab | 100% Onsite | Growing Pharmaceutical Testing Laboratory This Jobot Job is hosted by: Andrew Kraig Are you a fit? Easy Apply now by clicking the "Quick Apply" buttonand sending us your resume. Salary: $70,000 - $80,000 per year A bit about us: Founded over 20 years ago and based in South Plainfield, NJ, we are an FDA-registered, cGMP-compliant analytical testing laboratory specializing in OTC drugs, pharmaceuticals, cosmetics, dietary supplements, and botanical products. We provide method development, validation, stability testing, and release testing services to support regulatory compliance and product quality. Our laboratory operates under strict FDA, DEA, ISO, and USP standards to ensure accurate, reliable analytical results for our clients. Why join us? Competitive Compensation: Market-aligned base salary (DOE) Stability & Growth: Established FDA-regulated analytical lab Hands-On Technical Role: Extensive instrumentation exposure (LC, GC, ICP-MS, UV, IR, dissolution, etc.) Regulatory Experience: Work directly in FDA cGMP-compliant operations Professional Development: Exposure to method development, validation & QA collaboration Team Environment: Work closely with Laboratory and QA associates 100% Onsite – Fully equipped laboratory setting Job Details Key Responsibilities and Duties Independently execute validated analytical methods using LC, GC, IR, UV, dissolution, viscosity, melting point, and related instrumentation Prepare samples of OTC drug, pharmaceutical, cosmetic, dietary supplement, and botanical products Process and review instrument data (LC, GC, ICP-MS, etc.) for QA-ready reporting Maintain detailed, compliant documentation in accordance with FDA cGMP requirements Support method development, verification, validation, and transfer activities Participate in investigations including deviations, OOS/OOT, and CAPA Maintain laboratory equipment including calibration and troubleshooting Adhere to OSHA, chemical safety, and waste disposal procedures Occasionally assist with microbiology-related activities (media prep, environmental monitoring, aseptic handling) You should have most of the following: Bachelor’s degree in Chemistry (required) Minimum 3–5 years of experience in an industry chemistry lab (FDA-regulated preferred) Strong hands-on experience with HPLC and GC methods Experience working in FDA cGMP environments Familiarity with USP, ICH, and related regulatory guidelines Experience participating in OOS/OOT investigations and CAPA Ability to work independently in a fast-paced lab setting Basic microbiology exposure (media prep, aseptic techniques, environmental monitoring) Must be legally authorized to work in the US Must be able to commute to South Plainfield, NJ (no relocation) This is a 100% onsite role Interested in hearing more? Easy Apply now by clicking the "Quick 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

Production - Supply Chain Planner Job Number: 26-00839 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Production - Supply Chain Planner for our client in New Brunswick, NJ. ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity! Position Overview: The Manager, Operations Supply Planner supports the supply planning process for both external manufacturing and internal sites. This role ensures alignment with customer and market demand while maintaining operational efficiency. The Operations Supply Planner will interact with internal and external supply sites, logistics, and other supply chain teams. Responsibilities include assisting in the development of supply strategies, helping to create and execute supply plans, and identifying and reporting any risks or constraints that may affect product availability. Reporting Relationship: This role reports to the Director SPU Lead; Senior Director, SPU Lead or Associate Director, NSP. This position may also be a designee for their peers. Responsibilities: Supply Planning and Execution: Develop and manage supply plans for materials related to product portfolios. Support coordination with internal and external manufacturing sites to help balance customer service with operational efficiency. Maintain accurate inventory levels, ensuring purchase orders are up to date for Drug Substance, Drug Product and Finished goods to meet demand. Customer and Stakeholder Engagement: Build and maintain relationships with global and local supply chain teams and market stakeholders, collaborating to ensure continuity of supply and identify potential risks. Attend supply chain meetings to ensure alignment on customer requirements and consumption plans. Demand & Supply Alignment: Use ERP systems (e.g., SAP) to manage demand propagation and supply requirements, ensuring the MRP planning process runs effectively. Monitor changes in demand, communicate with stakeholders to adjust production plans, and incorporate these changes into site production schedules. Risk Management & Problem Solving: Monitor and assess inventory risks, including shortages, excess stock, and obsolescence. Assist to identify and resolve supply constraints, working closely with necessary stakeholders. Support inventory risks related to regulatory or artwork changes. Metrics and Reporting: Track and report on key supply chain performance metrics such as backorders, inventory compliance, and PO accuracy. Provide input into inventory projections, budget processes, and root cause analysis for any supply issues. Contribute to monthly and quarterly stock overviews, identifying any inventory risks or supply disruptions. Projects & Continuous Improvement: Participate in supply chain improvement projects and other initiatives to optimize supply chain processes. Support new product introductions, government tender supply programs, and clinical supply requests when required. Ensure that master data is accurately maintained and continuously updated in collaboration with relevant teams. Digital Acumen, Analytics, and Learning: Leverages visualization and data contextualization tools including Excel and BI platforms (e.g., Tableau, Power BI), integrated Client capabilities, and Client platforms to monitor KPIs, perform root cause analysis, review best action analysis and provide data-driven decision support. Contributes to process improvements through digitization and automation of planning workflows, supporting improved speed and accuracy. Executes task-level work using available tools (e.g. WMS, SAP, Tableau, Riverlogic, Kinaxis), follows SOPs, fulfills orders, and maintains high level of performance across data and planning accuracy. Demonstrates curiosity and adaptability in learning new digital tools and platforms (e.g., SAP, Kinaxis, forecasting systems), quickly integrating them into daily operations. Strong Planning and financial acumen with understanding of ERP transaction codes, planning / operational software, physical and transactional flows, etc. Familiarity with AI and ML systems features including performance & expectation management, optimization, etc. Qualifications: Required B.S. or BA in supply chain management, science and / or engineering (biotechnology, engineering or related sciences). APICS or related professional qualification, preferred. Min. 4 years’ experience in supply chain management, preferably within global manufacturing or pharmaceutical environments. Knowledge of supply chain operations. Expertise in ERP systems (e.g., SAP, Rapid Response) and related data analysis tools is preferred. Excellent interpersonal, communication, and negotiation skills. Base understanding of regulatory requirements, particularly in the pharmaceutical industry (cGMP, FDA, EMA). Strong problem-solving, analytical, and organizational skills. Ability to manage multiple tasks and prioritize effectively under tight deadlines. Pay Rate: $35.05 - $37.17 / Hour If hired, you will enjoy the following ECLARO Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO If interested, you may contact: June Binuya junethel.binuya@eclaro.com 212-804-7476 June Binuya | LinkedIn Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

Design Space InPharmatics, a leading international pharmaceutical consulting organization, is seeking an experienced Regulatory Medical Writer to support NDA submission programs for our growing portfolio of drug development clients. We are looking for a consultant with demonstrated expertise authoring and compiling FDA New Drug Application (NDA) submissions, specifically NDA Module 2 and Module 5 content in CTD/eCTD format. The ideal candidate will bring strong experience in clinical regulatory writing, integrated summaries, clinical study report development, and NDA submission strategy across small molecule and/or biologic drug products. This is a high-impact consulting engagement offering flexibility, and meaningful work at the forefront of regulatory drug development. Role and Responsibilities In this high-impact consulting role, the Regulatory Medical Writer will provide expert-level authoring and regulatory documentation support across a range of FDA NDA submission programs. Working remotely within a collaborative consulting team, the successful candidate will: • Author, edit, and compile NDA Module 2 clinical summaries and overviews, including Clinical Overview (Section 2.5), Clinical Summary (Section 2.7), Benefit-risk assessments and Integrated summaries of safety and efficacy., • Prepare and/or manage NDA Module 5 clinical documentation, including Clinical study reports (CSRs), Protocols and protocol amendments, Statistical analysis plans (SAPs), Case report tabulations, and listings coordination., • Ensure all documents comply with FDA guidance requirements, ICH CTD/eCTD standards, Good Clinical Practice (GCP), and internal quality and style standards., • Participate in submission planning, document gap assessments, and submission readiness reviews., • Support the preparation of responses to FDA information requests and review comments., • Coordinate timelines and deliverables to support NDA submission milestones., • Collaborate cross-functionally with clinical development teams, biostatistics, data management, pharmacovigilance, regulatory affairs, and medical affairs., • Function as a trusted regulatory writing subject matter expert within client project teams and CMO relationships., • Proactively flag gaps or risks relative to FDA expectations or industry best practices. Qualifications and Education Requirements • Advanced degree preferred (PharmD, PhD, MD, MS, or equivalent scientific discipline), Minimum 8–10 years of pharmaceutical or biotechnology regulatory writing experience., • Direct, hands-on experience authoring FDA NDA Module 2 and Module 5 content., • Strong knowledge of FDA NDA submission requirements, ICH E3 and CTD/eCTD structure, clinical trial documentation standards, and drug development processes. Preferred Skills • Experience with small molecule drug development programs., • Demonstrated expertise preparing integrated summaries of safety (ISS) and integrated summaries of efficacy (ISE)., • Familiarity with publishing systems and eCTD submission platforms., • Prior interaction with FDA review teams or support during regulatory agency meetings., • Consulting experience supporting multiple sponsors or parallel drug development programs., • Excellent scientific writing, editing, and data interpretation skills., • Ability to work independently and manage multiple deliverables in a fast-paced consulting environment. Additional Notes • Candidates who bring experience across both small molecule and biologic programs, or who have supported multiple NDA submissions across different therapeutic areas, will be especially well regarded. The responsibilities outlined in this position represent a general summary of the consulting role and are not intended to be all-inclusive. DSI reserves the right to amend this description as client program needs to evolve., • This is an excellent opportunity for a seasoned regulatory writing professional seeking to apply their expertise within a dynamic, market-leading consulting organization at the forefront of pharmaceutical regulatory strategy and drug development services., • This is a fully remote, independent consultant role. Consultants are engaged on a project basis and may be assigned to one or multiple concurrent engagements. Hours are not fixed and will fluctuate based on project requirements, milestones, and client needs., • All applications are reviewed by our human hiring team. No automated screening or AI-based filtering is used to evaluate or eliminate candidates. Every candidate receives personal consideration.

Job Title: Quality Control (QC) Manager Industry: Nutraceuticals / Dietary Supplements (CDMO) Location: New Brunswick, NJ Job Summary The Quality Control (QC) Manager is responsible for overseeing all laboratory and quality control functions within a dietary supplement CDMO environment. This role ensures that raw materials, in-process samples, and finished products meet established specifications and comply with regulatory requirements including FDA 21 CFR Part 111 and cGMP standards. The QC Manager will lead laboratory operations, manage a team of analysts, and support timely product release while maintaining the highest standards of quality, safety, and data integrity. Responsibilities • Oversee testing of raw materials , in – process samples and finished products ., • Ensure compliance with product specifications and release criteria, • Review and approve Certificates of Analysis (COAs), • Manage sampling plans, test schedules, and batch release timelines, • Supervise day-to-day QC laboratory operations (chemical and microbiological testing), • Ensure proper calibration, maintenance, and operation of analytical instruments (HPLC, GC,, • UV-Vis, etc.), • Maintain laboratory SOPs, test methods, and documentation, • Support internal, customer, and regulatory audits, • Maintain audit readiness and address observations, • Lead investigations for OOS (Out-of-Specification) and OOT (Out-of-Trend) results, • Lead, train, and mentor QC analysts and lab personnel, • Manage team performance, hiring, and development, • Promote a strong quality and compliance culture, • Partner with QA, Manufacturing, R&D, and Supply Chain teams, • Support product development, scale-up, and tech transfer activities, • Drive improvements in lab efficiency, turnaround time, and cost optimization Qualifications • Bachelor’s or Master’s degree in Chemistry, Biochemistry, Microbiology, Food Science, or, • related field, • 5+ years of experience in Quality Control within dietary supplements and nutraceuticals., • Experience in a CDMO or contract manufacturing environment preferred, • Hands-on experience with analytical techniques such as HPLC, GC, UV-Vis (ICP-MS is a plus), • Strong knowledge of microbiological testing methods, • Experience with method validation and stability studies, • Ability to work in a fast-paced, multi-client CDMO environment, • Effective communication and stakeholder management

Description: Job Summary The Senior Environmental Health & Safety (EHS) Manager is a full-time, exempt position at Kashiv BioSciences, LLC, responsible for leading and overseeing comprehensive EHS programs across two sites in New Jersey and Chicago. This role drives the development, implementation, and continuous improvement of initiatives that promote a safe and compliant work environment within a fast-paced biopharmaceutical production setting. The ideal candidate will ensure adherence to all applicable regulatory requirements while fostering a strong safety culture and proactively identifying opportunities to enhance workplace health and safety performance. Essential Duties & Responsibilities • Lead site safety programs and initiatives to promote a proactive safety culture and reduce workplace incidents, • Develop, implement, and maintain EHS policies, procedures, and training programs, • Conduct safety audits and hazard assessments within a manufacturing environment, • Ensure compliance with OSHA and other applicable regulatory requirements, • Lead incident and near-miss investigations and oversee corrective action implementation, • Track safety performance metrics and support continuous improvement initiatives, • Partner with operations leadership and HR on workers’ compensation and return-to-work processes, • Maintain required safety documentation and reporting, • Collaborate cross-functionally with operations, maintenance, and leadership to drive safety improvements and organizational change, • Employs EHS technical theories to solve practical problems., • Executes multiple, well defined EHS projects/assignments efficiently and documents the results expeditiously., • Becomes familiar with site processes, equipment, and EHS programs and works cross-functionally to complete EHS project work., • Support and maintain environmental and safety programs., • Oversees third party vendors while on site., • Applies established EHS standards and methods to identify, evaluate and control safety, health and environmental hazards present in the work operations and environment., • Evaluates operations to determine compliance with Kashiv BioSciences and governmental EHS standards and regulations., • Performs research and provides information on EHS matters., • Assists with developing and delivering EHS training and communications to persons internal to Kashiv BioSciences., • Assists with EHS program tasks and activities, including industrial hygiene, biosafety, ergonomics, process safety, environmental compliance, EHS inspections, fire protection, loss control, hazardous waste management and assistance with EHS committees., • Identifying latest innovations in EHS risk assessment and reduction, engineering design, operations, and pollution prevention or compliance strategies and making others aware of their potential application to assigned projects. Develop EHS strategies that identify and resolve potential EHS compliance problems before occurrence. Assist in resolving operational failures and inefficiencies that may manifest themselves as EHS deficiencies. Troubleshooting and solving problems relating to site operations systems and equipment., • Organizes daily activities, including technical components, to ensure timely completion of projects/assignments. Documents all work. Performs/supports planning of small EHS projects and interim goals for project completion and assists operational areas in plans to reach EHS compliance objectives. Participates in shutdown planning and scheduling, decontamination and decommissioning., • Works closely with site management and internal customers to assure compliance of ESH issues, equipment and documentation., • Complies with all company policies and standards. Requirements: Position Requirements and Qualifications Education: • Bachelor’s Degree in Safety, Environmental Health, Industrial Hygiene, or a related field (or equivalent experience) Experience: • 10+ years of EHS experience within a manufacturing environment in Pharma/Biopharma, • Strong knowledge of OSHA regulations and safety compliance programs, • OSHA industry training, • Experience leading safety training, audits, and incident investigations, • Experience working in regulated manufacturing environments (such as FDA or cGMP-regulated industries) preferred, • Experience supporting fast-paced production environments utilizing automated equipment or packaging systems preferred, • Ability to work cross-functionally and influence safety initiatives across departments, • Strong communication and collaboration skills with the ability to act as a change agent within operations, • Hazardous shipping guidelines, • Knowledge of MSDS, • Direct experience with regulated environments (e.g., cGMP, OSHA, EPA) preferred., • Experience of working in a highly regulated environment would be a significant advantage. Ideal characteristics: • Remains calm under pressure, displaying a positive, solution driven approach., • Displays key leadership skills, being visible, approachable, and accountable., • Understands Kashiv’s commitments and delivers with passion and urgency., • Act with honesty, integrity and respect for people and goals., • Can prioritize activities and own workload, ensuring vital tasks are recognized and acted upon. Special Skills: • Has Subject Matter Expertise in relevant EHS regulations, principles, pollution control technology, industrial hygiene and safety-related equipment & safeguards. Has basic technical knowledge and works on practical, worker health, safety and environmental problems., • Can effectively interact with team members. Can articulate the issues and solutions to teams upon which participates., • Can identify EHS technical problems, analyze effectively and solve in consultation with supervisor. Learns to develop investigation and problem-solving skills using standard safety engineering and technology techniques., • Can develop, analyze and interpret data., • Can collaborate with others to determine areas of potential risk to business success and generate gap analysis., • Skill to document technical assignments expeditiously., • Capable to work on multiple small projects simultaneously and meet deadlines., • Self-starter to manage workload and meet deadlines set by upper management. Gathers experience in planning work product deliverables to team projects to assure projects stays on track., • Learns application of basic safety engineering and science skills in product or process evaluation under supervisor., • Ability to work with contractors and provide support to others who review/approve and manage external EHS services in meeting business initiatives., • Maintains gowning certification for clean room activities. Work Environment & Physical Demands: General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel will be involved. Supervisory Responsibility, if any: No This position description is not a complete list of all responsibilities, duties or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization. PI661fcf2b660d-37820-40298567

Company Overview: Prinston Pharmaceutical, Inc. is a fully integrated, mid-sized pharmaceutical company focused on the development, manufacturing, and commercialization of high-quality, affordable generic medicines in the United States. Building on a strong foundation of cGMP-compliant operations, we combine the reliability of an established platform with the agility and ambition of a growing organization. Our expanding portfolio and pipeline—particularly in complex generics—reflect a commitment to bringing cost-effective therapies to market with speed, quality, and precision. As we continue to scale, we operate with a lean, execution-driven model where experienced professionals have the opportunity to influence strategy, drive decisions, and make a measurable impact. We are committed to maintaining the highest standards of quality, compliance, and integrity while advancing access to essential medicines. Position Overview: Prinston Pharmaceutical Inc. is seeking a high-caliber, strategic Regulatory Affairs Director to lead our complex portfolio, including Biosimilars (351(k)) and 505(b)(2) innovative products. The Director will serve as the primary architect of regulatory strategy, navigating the evolving FDA landscape to ensure successful product approvals and lifecycle management. Key Responsibilities: • Strategic Leadership: Lead the development of innovative regulatory strategies for biosimilars, aligning with corporate goals and navigating the 351(k) pathway requirements, as well as complex regulatory strategies for 505(b)(2) products., • Submission Oversight: Provide executive-level oversight and final review for all eCTD submissions, ensuring the technical and scientific integrity of Biosimilar and 505(b)(2) filings, amendments, and supplements., • FDA Liaison: Serve as the primary, high-level liaison with the FDA; lead formal negotiations and represent the company in all strategic meetings regarding development and filing pathways., • Quality & Compliance Leadership: Direct the critical review of complex source documents (clinical, analytical, and CMC) to ensure they exceed the highest standards of technical adequacy and align with current cGMP and Agency guidance., • Regulatory Intelligence: Proactively monitor, interpret, and communicate the impact of emerging regulations, guidance (including BPCI Act updates), and industry trends on the company's long-term portfolio., • Cross-Functional Partnership: Act as a key strategic partner to manufacturing, clinical, and operation teams, providing high-level regulatory guidance to drive project timelines. Qualifications: • Master’s degree or PhD/PharmD in a relevant scientific field, with extensive experience in the pharmaceutical industry., • Must have significant regulatory experience in biosimilars (351(k)); deep experience with 505(b)(2) or complex innovative products is required., • At least 10-12 years of progressive experience in pharmaceutical regulatory affairs; expert knowledge of cGMP is required., • Proven track record of successful FDA interactions and leadership of complex regulatory submissions., • Excellent executive-level communication, team leadership, and strategic decision-making skills. Compensation & Benefits: • Base salary: $150,000 – $200,000, • With bonus Location: NJ Benefits: • 401(k), • Health insurance, • Dental insurance, • Paid time off, • Vision insurance Job Type: Full-time

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: _ Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. We welcome applicants who are open to relocating to the area. The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. This position has a leadership role to proactively develop plans for the utilization of EDC system processes and other clinical data applications that allow for internal control of clinical databases. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC Documentation. She/He may have supervisory responsibilities for both internal staff and external consultants. They may also manage direct reports and work cross-functionally with various internal departments and external resources on Data Management related issues. The Associate Director, Clinical Data Management, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. . ESSENTIAL FUNCTIONS Primary duties/responsibilities: Ensure the data collected meets the requirements of the study objective and company quality standards. Assist in the development and implementation of strategic vision for data management (DM) group. Collaborate with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end. Work closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to design and develop data collection instruments (e.g., eCRF's) to ensure the required information is captured for statistical analysis. Oversee coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding Lead data management activities, clinical database cleaning in EDC, data reconciliation with external vendor data, SAE reconciliation and lock activities. Lead development of data management plans, data review plans, supervise database development, and reviewing and processing of clinical trial data to ensure completeness, accuracy, and consistency of clinical trials data. Prepare and distribute or facilitate distribution of periodic reports of study status including, case report form (CRF) completion status, missing pages, query aging, clean patient tracker (CPT), etc. Participate in cross functional team meetings, as requested, and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs. Lead interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data. Develop and update SOP's and other documents associated with the data collection, handling, and review processes, e.g., Working Instructions (WI), Best Practices Documents (BPD)to meet regulatory compliance and operational needs. Participate in clinical review and validation of statistical outputs used in the preparation of final reports. Mentor clinical team members by resolving problems and providing DM guidance. Manage multiple and varied tasks, prioritize workload with attention to detail. Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team. Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities. Lead the completion of data management activities to meet project timelines and communicate status to respective team members. Contribute to the development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement. May manage, coach, and mentor direct reports. Performs other tasks and assignments as needed and specified by management. KNOWLEDGE/SKILLS/ABILITIES REQUIRED • Minimum level of education and years of relevant work experience. Bachelor's degree in science or related field (such as healthcare) and a minimum of 8 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions. • Special knowledge or skills needed and/or licenses or certificates required. Experience in second-line management and functional leadership. Previous leadership of vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (PRO) and other database technologies. Highly detail oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages. Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines. Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g., data review, study reports, regulatory submissions, safety updates, etc.). Strong verbal and written communication, decision-making, influencing, negotiation, and project management skills. Technical skills and experience using Medidata or relational databases (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization tools (e.g., Spotfire, J-Review, Business Objects). Proficiency in the use of Microsoft Office Suite of tools (Word, Excel, etc.). Learning agility and 'scalability' to take on increasing responsibility Excellent time management, flexibility, ability to coordinate workload and meet established deadlines. Ability to influence without direct authority. Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. *Special knowledge or skills and/or licenses or certificates preferred. Minimum five (5) years' experience with Medidata RAVE(EDC, R2DS/RBS, Architect). Experience with Medidata RAVE. Strong understanding and application of regulatory requirements and relevant data standards; CDISC knowledge and experience. Experience in PL/SQL, SAS, Java, C++ relational database design and database programming skills preferred. • Travel requirements 5- 15% Expected Base Salary Range $163,800 - $206,200. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans. #LI-NM1 EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. _

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: _ Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. We welcome applicants who are open to relocating to the area. The Director, Clinical Data Management provides strategic and operational leadership and oversight of data management activities to ensure the quality, integrity, consistency and inspection readiness of clinical databases for subsequent analysis, reporting and regulatory submissions. This position has a leadership role to proactively develop plans for the utilization of EDC system processes and other clinical data applications that allow for internal control of clinical databases. This position will lead/contribute in defining Sponsor processes and procedures for maintaining clinical data and the associated Quality Assurance (QA) Quality Control (QC) documentation. She/He may have supervisory responsibilities for both internal staff and external consultants and may manage direct reports. The incumbent works cross-functionally with various internal departments and external resources on Data Management related issues. The Director, Clinical Data Management, ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. ESSENTIAL FUNCTIONS Primary duties/responsibilities: Ensure the data collected meets the requirements of the study objective and company quality standards. Drives the development and implementation of strategic vision for data management (DM) group. Provide functional oversight of CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end. Partners with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to design and develop data collection instruments (e.g., eCRF's) to ensure the required information is captured for statistical analysis. Oversee and as needed, directly support coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding Lead data management activities, clinical database cleaning in EDC, data reconciliation with external vendor data, SAE reconciliation and lock activities. Lead development of data management plans, data review plans, supervise database development, and reviewing and processing of clinical trial data to ensure completeness, accuracy, and consistency of clinical trials data. Prepare and distribute or facilitate distribution of periodic reports of study status including, case report form (CRF) completion status, missing pages, query aging, clean patient tracker (CPT), etc. Participate in cross functional team meetings, as requested, and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs. Lead interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data. Develop and update SOP's and other documents associated with the data collection, handling, and review processes, e.g., Working Instructions (WI), Best Practices Documents (BPD)to meet regulatory compliance and operational needs. Facilitates and contributes to regulatory submissions and audit/inspection activities. Gathers requirements related to existing clinical systems to identify opportunities to enhance, improve and streamline processes and systems use. Leads the assessment and selection of Data Management vendors and systems for clinical data collection and analysis. Participate in clinical review and validation of statistical outputs used in the preparation of final reports. Mentor clinical team members by resolving problems and providing DM guidance. Manage multiple and varied tasks, prioritize workload with attention to detail. Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team. Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities. Lead the completion of data management activities to meet project timelines and communicate status to respective team members. Contribute to the development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement. May manage, coach, and mentor direct reports. Performs other tasks and assignments as needed and specified by management. KNOWLEDGE/SKILLS/ABILITIES REQUIRED • Minimum level of education and years of relevant work experience. Bachelor's degree in science or related field (such as healthcare) and a minimum of 10 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions. • Special knowledge or skills needed and/or licenses or certificates required. A proven track record of successful leadership of data management team(s). Previous leadership of vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (ePRO/eCOA) and other database technologies. Highly detail oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages. Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines. Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g., data review, study reports, regulatory submissions, safety updates, etc.). Strong verbal and written communication, decision-making, influencing, negotiation, and project management skills. Technical skills and experience using Medidata or relational databases (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization tools (e.g., Spotfire, J-Review, Business Objects). Proficiency in the use of Microsoft Office Suite of tools (Word, Excel, etc.). Learning agility and 'scalability' to take on increasing responsibility Excellent time management, flexibility, ability to coordinate workload and meet established deadlines. Ability to influence without direct authority. Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Knowledge of different regulatory standards and requirements, including but not limited to FDA, EMEA, and PMDA. *Special knowledge or skills and/or licenses or certificates preferred. Minimum five (5) years' experience with Medidata RAVE (EDC, R2DS/RBS, Architect, Coder). Strong understanding and application of regulatory requirements and relevant data standards; CDISC knowledge and experience. Experience in PL/SQL, SAS, Java, C++ relational database design and database programming skills preferred. Understanding of Compliance and Regulations, such as ICH, GxP, Annex 11, GDPR and GAMP. Understanding of the use of risk-based approach for process efficiency and compliance. Clinical Data Interchange Standards Consortium (CDISC) experience. • Travel requirements 25% Expected Base Salary Range $200,700 - 252,600. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans. EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. _

Position Title: Supply Chain Planner Work Location: New Brunswick, NJ 08901 Assignment Duration: 12 Months Work Schedule: Mon-Fri (normal business hours) Work Arrangement: Hybrid The Manager, Operations Supply Planner supports the supply planning process for both external manufacturing and internal sites. This role ensures alignment with customer and market demand while maintaining operational efficiency. The Operations Supply Planner will interact with internal and external supply sites, logistics, and other supply chain teams. Responsibilities include assisting in the development of supply strategies, helping to create and execute supply plans, and identifying and reporting any risks or constraints that may affect product availability. • Supply Planning and Execution:, • Develop and manage supply plans for materials related to product portfolios, • Support coordination with internal and external manufacturing sites to help balance customer service with operational efficiency., • Maintain accurate inventory levels, ensuring purchase orders are up to date for Drug Substance, Drug Product and Finished goods to meet demand, • Customer and Stakeholder Engagement:, • Build and maintain relationships with global and local supply chain teams and market stakeholders, collaborating to ensure continuity of supply and identify potential risks, • Attend supply chain meetings to ensure alignment on customer requirements and consumption plans, • Demand & Supply Alignment:, • Use ERP systems (e.g., SAP) to manage demand propagation and supply requirements, ensuring the MRP planning process runs effectively, • Monitor changes in demand, communicate with stakeholders to adjust production plans, and incorporate these changes into site production schedules, • Risk Management & Problem Solving:, • Monitor and assess inventory risks, including shortages, excess stock, and obsolescence, • Assist to identify and resolve supply constraints, working closely with necessary stakeholders, • Support inventory risks related to regulatory or artwork changes, • Metrics and Reporting:, • Track and report on key supply chain performance metrics such as backorders, inventory compliance, and PO accuracy, • Provide input into inventory projections, budget processes, and root cause analysis for any supply issues, • Contribute to monthly and quarterly stock overviews, identifying any inventory risks or supply disruptions, • Projects & Continuous Improvement:, • Participate in supply chain improvement projects and other initiatives to optimize supply chain processes, • Support new product introductions, government tender supply programs, and clinical supply requests when required, • Ensure that master data is accurately maintained and continuously updated in collaboration with relevant teams, • Digital Acumen, Analytics, and Learning, • Leverages visualization and data contextualization tools including Excel and BI platforms (e.g., Tableau, Power BI), integrated APS capabilities, and platforms to monitor KPIs, perform root cause analysis, review best action analysis and provide data-driven decision support., • Contributes to process improvements through digitization and automation of planning workflows, supporting improved speed and accuracy., • Executes task-level work using available tools (e.g. WMS, SAP, Tableau, Riverlogic, Kinaxis), follows SOPs, fulfills orders, and maintains high level of performance across data and planning accuracy., • Demonstrates curiosity and adaptability in learning new digital tools and platforms (e.g., SAP, Kinaxis, forecasting systems), quickly integrating them into daily operations., • Strong Planning and financial acumen with understanding of ERP transaction codes, planning/operational software, physical and transactional flows, etc., • Familiarity with AI and ML systems features including performance & expectation management, optimization, etc., • Required B.S. or BA in supply chain management, science and/or engineering (biotechnology, engineering or related sciences)., • APICS or related professional qualification preferred., • Min. 4 year of experience in supply chain management, preferably within global manufacturing or pharmaceutical environments., • Knowledge of supply chain operations., • Expertise in ERP systems (e.g., SAP, Rapid Response) and related data analysis tools is preferred., • Excellent interpersonal, communication, and negotiation skills., • Base understanding of regulatory requirements, particularly in the pharmaceutical industry (cGMP, FDA, EMA)., • Strong problem-solving, analytical, and organizational skills., • Ability to manage multiple tasks and prioritize effectively under tight deadlines., • Travel Requirements: Ad hoc and with notice (up to 10%).

IPR analysis, FTO opinions; regulatory filings, AML/BSA, OFAC, FCPA, HIPAA, FDA, GDPR/CCPA, export controls) - Review and grade AI responses for legal accuracy, sound reasoning, and adherence to professional standards - Produce model "golden answer" responses and detailed rationale to improve mode

AML/BSA program evaluation) - Provide structured feedback on AI accuracy in areas such as regulatory standards (FINRA, OCC, FFIEC, FDA, SEC, GDPR, HIPAA), risk frameworks (COSO, ISO 31000), and industry-specific compliance terminology - Collaborate asynchronously with research teams to refine evalua

Job Summary Are you ready to take your skills to the next level and make a real impact? IFF is a global leader in flavors, fragrances, food ingredients and health & biosciences. We deliver sustainable innovations that elevate everyday products. Taste:Crafting unique, technology-enabled flavor designs that define the identity of food and beverage brands, shapetrends in flavor building and fuel market success. The role is based in South Brunswick, NJ (onsite). Be part of a detail-oriented, compliance-driven, collaborative team where together we can achieve greatness and make a real impact. Your potential is our inspiration. Where You'll Make a Difference Support daily quality and food safety operations on the plant floor Assist the Supervisor Product Safety Site Leader in maintaining site compliance Maintain and update Food Safety Plans in accordance with FSMA Support development and implementation of HACCP, SOPs, and SSOPs Participate in food safety and quality committees, including allergen control, sanitation, and traceability Partner with Production and Maintenance to troubleshoot quality issues Support equipment commissioning and process improvement initiatives Maintain accurate records for FDA and regulatory compliance Interact cross-functionally to support audits and inspections as needed Bachelor's Degree in food science, food microbiology, food safety or related field Experience supporting quality and food safety programs in a manufacturing environment Excellent organizational, written and verbal communication skills with the ability to effectively communicate within all levels of the company and with suppliers Proficient in Microsoft Office applications and other software tools required for data entry and reporting Working knowledge of FSMA, HACCP, GMPs, SOPs, and SSOPs Strong documentation and record-keeping skills Ability to work hands-on and interface directly with plant floor teams Experience training employees and contractors on food safety practices Ability to support investigations and corrective actions Effective communication skills across multiple functions How Would You Stand Out? Certified in HACCP PCQI certificate in Preventive Controls for Human and Animal Foods Experience in FDA-regulated food or ingredient manufacturing Audit experience using GFSI schemes; FSSC 22000 preferred Active participation in food safety or quality committees Involvement in equipment commissioning or process validation Why Choose Us? Be part of a global organization committed to food safety excellence Work in a highly visible, operationally critical role Training opportunities Learning and development programs from day one Our benefit package includes medical, dental, vision, 401k, vacation, holidays, 16 weeks paid parental leave (maternity and paternity) and an annual bonus plan Salary Range: $65,000 - $75,000 We are a global leader in taste, scent, and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy. At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex, or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability. Visit _ to learn more Salary Ranges: $70352- $87940

Job DescriptionObjective The Process Engineer will provide technical support for GMP drug product manufacturing operations. This role will provide technical support and conduct investigations into product/process quality events and customer complaints; identify, assess, and execute projects to optimize existing processes, raw materials, components, and packaging in manufacturing and final product packaging; work with multi-functional teams to execute and deliver assigned projects, including specification, conceptual development, protocol writing, selection, testing, and qualification. This is a hybrid role, based part-time in the office and part-time remote, with the office located in Somerset, NJ. Travel will be required to our Iowa facility. Ability to support travel 25%. Essential Functions • Identify opportunities to improve quality, efficiency, and customer service through changes to product components, component processing, and component inspection. Evaluate those opportunities and present projects to management for approval to implement changes., • Work with multi-functional teams to execute product and packaging projects to improve and optimize manufacturing and packaging processes. Support complex projects to meet established timelines without impacting manufacturing. Proactively adjust schedules to meet changing priorities., • Provide technical support for the transfer of new or improved manufacturing processes between functional groups or sites, ensuring knowledge capture and compliance with quality and regulatory standards., • Write and execute validation protocols either acting as the study director/validation engineer or working with the Validation department., • Lead and participate in investigations to drive technically and scientifically sound corrective and preventative actions. Apply creative problem-solving techniques using knowledge base and historical experience to address immediate, short-term, and future needs. Lead root-cause analysis investigations as a technical resource., • Investigate product complaints and write reports of investigations. Assist as required to support conclusion and possible corrective actions., • Provide support in the development, review, and maintenance of various radiopharmaceutical and cGMP documents, including Standard Operating Procedures (SOPs), Batch Records, Work Instructions and technical documents., • Assist in the development of training materials and conduct training sessions for target audience on document updates, providing clarity and guidance, ensuring full compliance., • Present data and information as a technical subject matter expert to regulatory agencies., • Actively promote safety. Always demonstrate good safety practices including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards, • Write and manage actions for change controls in Quality Management System (QMS) as applicable for tech transfers., • Stay up to date with industry regulations and guidelines (e.g., FDA, EMA) to ensure that all documentation meets regulatory requirements and contributes to regulatory submissions.Education/Experience, • Bachelor’s Degree in Engineering or related scientific discipline., • Minimum 2 years of experience in pharmaceutical or medical device manufacturing or other related regulated industry., • Expert knowledge of MS Office suite., • Previous experience working with radiopharmaceuticals and CMOs strongly preferred.Knowledge/Skill/Ability, • Must possess excellent written, verbal and presentation skills. Must be able to communicate effectively with all levels of management, both internal and external., • This individual should be a self-starter with the ability to work well both independently and in a team environment., • Demonstrated technical problem-solving skills with root cause analysis tools., • Direct experience with project management skills., • Excellent organizational and time management skills., • Establishes strong inter-departmental relationships and is viewed as a valuable technical resource to others., • Direct experience with technical transfer and aseptic/parenteral pharmaceutical process validation methodologies, • Familiar with Code of Federal Regulations (CFR) parts 210 and 211 and supporting regulatory inspections, • Experience in drafting and reviewing Chemistry, Manufacturing and Controls (CMC) regulatory filing sections, • Ability to support travel 25%.Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. During this job, the employee may encounter exposure to radiation hazards. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com. Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Powered by JazzHR tzuk0kNJ02

Job DescriptionSalary: The START Center for Cancer Research (START) is the worlds largestearly phasesite network, fully dedicated tooncologyclinical research.Throughout ourhistory, START has provided hope to cancer patients inglobalcommunity practices by offering access tocutting edgetrials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, STARTs mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapiesconductedat STARTlocationshave obtained FDA/EMA approval.Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population leavingthe majority ofpatients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world.As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda the most effective cancer drug in medical history. We are seeking a Clinical Principal Investigator. The Clinical Principal Investigator (PI) is a physician-scientist responsible for the overall preparation, conduct, and management of sponsored projects, ensuring compliance with all regulatory requirements and institutional policies. This role will manage the development and execution of clinical trial protocols, contribute to data analysis, and maintain strong communication and alignment with sponsors. Essential Responsibilities • Manage early phase clinical trials by providing overarching medical direction and comprehensive medical reviews of protocols in conformance with the investigational plan and good clinical practice., • Provide medical and scientific feasibility of all new sponsor inquiries driving growth through strategic partnerships., • Lead and manage a matrix team of responsible for responsible for the conduct of early phase oncology trials., • Ensure the safety and well-being of all participants in the study at the trial site are protected., • Ensure data collected at the study site is credible and accurate., • Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected., • Develop close personal working relationships with Sponsors and Clinical Research Organizations involved in study conduct., • Provide expert guidance and support to clinical operations research staff and sponsor client., • Lead continuous quality improvement efforts for clinical research services, integrating best practices and fostering a culture of research excellence., • Develop and implement strategies to enhance patient recruitment and retention in clinical trials. Required Education and Experience: • M.D. or equivalent., • Board Certified in Hematology and/or Medical Oncology., • Clinical trials experience with a strong interest in drug development., • Ability to critically analyze clinical scientific data and literature., • Understanding of GCP principles, safety and adverse event reporting, FDA regulations, and biomedical research ethics., • A passion for providing excellent clinical care and for working in a collaborative / team-oriented environment. Preferred Education and Experience: • Previous experience with industry sponsored clinical trials., • Excellent communication skills, with experience in publishing and presenting at scientific meetings., • Translational research experience and familiarity with pharmacokinetics and pharmacodynamics. More aboutTheSTART Center for Cancer Research Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials,including for43 therapies that were approved by the FDA. STARTrepresentsthe worlds largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more atSTARTresearch.com. Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Yourexpertiseand dedication can help us bring hope and healing to patients worldwide.Pleasesubmityour application online. We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Job Description Company Overview: We are a dynamic and innovative small biotechnology company dedicated to advancing oncology research through cutting-edge translational science. Our mission is to translate scientific discoveries into tangible therapeutic solutions that make a meaningful impact on cancer patients' lives. We are seeking a talented and motivated Translational Scientist to join our team and contribute to our mission-driven work. Position Overview: As a manager of clinical pharmacology you will be responsible for providing clinical pharmacology input in early (up to proof-of-concept stage) and late-stage clinical development. You will be responsible for representing clinical pharmacology function on drug development teams, providing input on the dose and the design of early and late-stage clinical trials, and for interacting with the clinicians and the clinical operations group for the execution of the clinical pharmacology components (PK, PD, biomarkers, etc) of the trials. In addition, you will be responsible for performing clinical PK/PD analyses, for providing subject matter leadership related to clinical ADME, pre-clinical to clinical extrapolation and selection of dose/regimen during early development. Additionally, you will be responsible for providing input on study design and leading the selection of doses for late-stage clinical studies. You will contribute to the preparation of the regulatory documents such as briefing books for pre-agency meetings, IBs, INDs, and IMPD dossiers, protocols, and clinical study reports. You will closely collaborate with other development-functions (Toxicology, Bioanalytical, Non-clinical PK/PD, Pharmacometrics and Physiological PK/PD Modeling and Simulation, Biomarkers, Biostatistics and Data Management, Clinical Operations, and Clinical Development) to bring drug candidates from IND stage to NDA. You will be responsible for working within the department level budget and resources. Support technical due diligence efforts for business development. Responsibilities: • Responsible for providing support for the preparation of the clinical pharmacology (PK, biomarkers, bioanalytical) sections of early and late-stage clinical protocols, Clin Pharm development plans, modeling & simulation plans, • Contribute to the preparation of the pre-IND, IND, IB and NDA/BLA documents, • Responsible for the pharmacokinetic and PK/PD data analyses using standard industry data analysis software, • Contribute to the design of early phase clinical trials (FIH to POC) and support project goals, • Responsible for recommending the starting dose in FIH trials based on allometric scaling or physiologically based PK modeling, • Conduct assessments of relevant exposure vs. response data for supporting dose selection during and post POC, • Contribute to the design of late-stage clinical trials (POC-NDA/BLA) and support project goals, • Responsible for leading the dose selection for Phase II and III clinical trials based on PK, PD biomarker and efficacy data analysis from previous studies., • Responsible for the preparation of the PK/PD reports and clinical study reports, • Represent Clin Pharm function for the project team at the regulatory agencies during regulatory meetings., • Provide clinical pharmacology input and collaborate across all areas of drug development, along with research, preclinical, bioanalytical and clinical development functions., • Provide oversight to vendors and ensure high quality deliverables that meet study/project timelines, • Develop standard working procedures for operation and data analysis Experience: • 3+ years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics and other clinical pharmacology components of early clinical trials within the pharmaceutical or biotech industry., • Exposure to biologics drug development. Knowledge of basic and clinical immunology is plus., • Hands on knowledge of PK/PD and statistical analyses methods used in analyzing early clinical phase data., • Knowledge of general regulatory process and experience in contributing to IND, EOP1, EOP2, and pre-BLA/NDA meetings with the FDA , EMA and other health authorities., • Excellent written and oral communication skills including good presentation skills. Qualifications: • Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacokinetics, pharmacology, or relevant life science discipline such as biology, immunology., • Hands-on experience with pharmacokinetic/pharmacodynamic data analyses using standard industry data analysis software., • Familiar with PK/PD concepts. principles and applications to support prospective dose/regimen recommendations for planned Phase 1, 2 and 3 trials., • Experience in preparing clinical pharmacology components of clinical study protocols and clinical study reports., • Knowledge of current practices and issues in the bioanalytical and drug metabolism areas., • Proficient in the use of Microsoft Word, Excel and PowerPoint. Travel: • Ability to travel domestic and internationally ≤ 20%. Benefits: Competitive salary commensurate with experience Comprehensive benefits package, including medical, dental, and vision coverage Opportunities for career growth and professional development Collaborative and dynamic work environment with a diverse team of scientists and clinicians Opportunity to make a meaningful impact on cancer patients' lives through innovative translational research

Job Description SOKOL GxP Services is seeking a Production – Supply Chain Planner to support supply planning operations within a pharmaceutical manufacturing environment. This role supports both internal and external manufacturing sites and helps ensure alignment between customer demand, inventory strategy, and operational efficiency. The Supply Chain Planner will collaborate with supply sites, logistics teams, and cross-functional stakeholders to support supply continuity, manage inventory risks, and maintain accurate planning data within ERP systems. Requirements • Develop and manage supply plans for materials and product portfolios, • Coordinate with internal and external manufacturing sites to support customer demand and operational efficiency, • Maintain inventory accuracy and support purchase order management for drug substance, drug product, and finished goods, • Monitor demand changes and adjust planning activities and production schedules accordingly, • Identify and communicate supply risks, shortages, excess inventory, and operational constraints, • Support inventory investigations related to regulatory or artwork changes, • Participate in supply chain meetings and collaborate with global and local stakeholders, • Track and report key supply chain metrics including inventory compliance, PO accuracy, and backorders, • Support monthly and quarterly stock reviews, forecasting activities, and root cause analysis, • Participate in process improvement initiatives and support new product introductions and clinical supply requests, • Ensure master data is accurately maintained and continuously updated, • Utilize ERP and planning systems including SAP and related supply planning tools, • Support data analysis and reporting activities using Excel and BI platforms such as Tableau or Power BI Qualifications • Bachelor’s degree in Supply Chain Management, Engineering, Biotechnology, Science, or related field required, • Minimum 4 years of supply chain management experience, preferably within pharmaceutical or global manufacturing environments, • Strong understanding of supply chain operations, inventory management, and planning workflows, • Experience with ERP systems such as SAP; Rapid Response experience preferred, • Familiarity with pharmaceutical regulatory requirements including cGMP, FDA, and EMA environments preferred, • Strong analytical, organizational, communication, and problem-solving skills, • Ability to manage multiple priorities and work effectively under tight deadlines, • APICS or related certification preferred Benefits Competitive hourly rate: $31.50 – $34.30/hr (W-2 only, no C2C) Hybrid position - 50 % on site Working Hours: Monday - Friday, regular business hours 12-month contract with possible extension Health insurance, holiday pay, 401(k) program, and other benefits Employee referral bonus program

Job Description This Notice is provided as a result of the filing of applications for permanent alien labor certification for the positions noted below. Any person may provide documentary evidence bearing on an application to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue NW, Room N–5311, Washington, DC 20210. Employer: Bentley Laboratories, LLC Job Title: Product Development and Innovation Lead Job Requisition: A279.50.4 Job Location: Edison, New Jersey Job Type: Full Time Rate of Pay: $99,000 to $109,000 per Year Duties: · Conduct white gap analysis for existing brands and create concepts that fit our customer brand ethos; · Research ingredients for each category: skincare, haircare and suncare, and maintain an Innovation Ingredient Database; · Write formulas based on these concepts, make samples, and ensure stability to showcase new and existing brands; · Work on building an Innovation Library with potential shelf-ready formulas and concepts; · Create aesthetic presentations to present to top brands in the business’ portfolio; · Help business development by pitching new concepts and ingredients to potential customers; · Actively work with raw material vendors and act as a liaison with R&D to help with new ingredients to aid existing PDRs; · Conduct in-depth market analysis and keep up with beauty industry trends, attend tradeshows, and maintain vendor relationships. Telecommuting permitted up to 10% Requirements: Employer will have a Master’s degree in Chemistry, Cosmetic Science, or related field plus 2 years of experience in job offered or in a Product Development and Innovation Lead-related occupation. Position requires demonstrable experience in the following: · Formulating personal care products with at least two years of experience in skin care and hair care. · Utilizing the principles of organic chemistry, physical chemistry, and cosmetic chemistry (including skin and hair processing) to understand how ingredients interact with each other and create stable formulations. · Working within the regulatory requirements of US, EU and China to create globally compliant formulations. · Utilizing Over the Counter (OTC) experience including knowledge of Food and Drug Administration (FDA) monograph as well as global rules and regulations with respect to artwork and labeling. · Utilizing bulk manufacturing, filling, packing and kettle configuration knowledge to develop manufacturing process from scale up to commercial size with consistent quality. · Working within FDA regulations and Good Manufacturing Practice (GMP) requirements to create OTC formulations; and · Utilizing expert knowledge of Chemistry and Polymer Science to interact efficiently with suppliers around the globe and select ingredients that are stable, efficacious, natural, and meet the customer’s cost. Telecommuting permitted up to 10% Contact: To apply, please email your resume to Hr@bentleylabs.com referencing job code A279.50.4.

Job DescriptionBenefits/Perks • Highly enriched & healthy work environment, • Excellent growth opportunities, • Competitive Pay, • Career AdvancementJob SummaryWe are seeking an experienced Quality Assurance Specialist to join our team. In this role, you will be responsible for overseeing the quality of goods and services our company provides. You will perform routine inspections, implement quality assurance policies and procedures, and identify any workflow issues. The ideal candidate is an excellent verbal and written communicator with strong attention to detail. Position Summary The Quality Assurance Specialist – Clinical Trial Supply plays a critical role in ensuring the quality, safety, integrity, and compliance of clinical trial materials throughout their lifecycle—from receipt and storage to packaging, labeling, distribution, and returns. This role supports GxP operations, oversees Quality System activities, and collaborates cross-functionally with Operations, Warehouse, Packaging, Project Management, and external suppliers/CROs to maintain compliance with FDA, EU-GMP, GDP, ICH-GCP, DSCSA, and internal JRS standards. The QA Specialist ensures that all products and processes meet regulatory and customer expectations while supporting JRS’s mission to deliver reliable, resilient, and high-quality clinical supply solutions worldwide. Key Responsibilities 1. Quality Systems & Compliance • Ensure compliance with GMP, GDP, GCP, ICH, FDA, EMA, MHRA, TGA, CDSCO and JRS internal SOPs., • Review, approve, and maintain controlled documents including SOPs, Work Instructions, Forms, Batch Records, Labeling Specs, and Packaging Records., • Support implementation and continuous improvement of Quality Management Systems (QMS) including Deviation Management, CAPA, Change Control, Training, and Document Control., • Participate in internal audits, customer audits, vendor qualifications, and regulatory inspections. 1. Clinical Supply Chain Quality Oversight • Perform QA review and approval of:, • Incoming clinical supplies (comparator drugs, IMPs, ancillary supplies), • Packaging and labeling activities, • Storage and temperature monitoring records, • Distribution documentation including shipping records, AWBs, and temperature logger data, • Verify completion and accuracy of Line Clearance, Batch Packaging Records (BPR), and Label Control Logs., • Review and approve EPCIS/DSCSA traceability files, CoA/CoC, pedigrees, and other regulatory documentation. 1. Investigations & Deviation Management • Lead or support investigations for:, • Temperature excursions, • Packaging or labeling discrepancies, • Shipment issues, • Supplier or customer complaints, • Perform root cause analysis (RCA), risk evaluation, and implement effective CAPAs. 1. Vendor & Customer Quality Support • Support supplier qualification by reviewing:, • GMP/GDP licenses, • ISO certifications, • Quality Agreements (QTA), • Questionnaires and risk assessments, • Collaborate with customers to ensure project-specific quality requirements are met. 1. Documentation & Regulatory Support • Ensure accurate completion of QA documentation related to:, • Clinical supply release, • Temperature-controlled shipping, • Storage of controlled and non-controlled materials, • Destruction, return, and reconciliation, • Maintain updated Quality and Technical Agreements (QTA) with clients and suppliers. 1. Training & Continuous Improvement • Deliver and maintain training programs for QA and Operations teams on:, • GDP/GMP compliance, • SOP revisions, • Packaging and labeling quality requirements, • Temperature control best practices, • Participate in continuous improvement initiatives to enhance operational efficiency and compliance. Required Qualifications • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or related field., • 2–5 years of experience in Quality Assurance within Clinical Trial Supply, Pharmaceutical, Biotech, CRO, CDMO, or GMP/GDP warehouse environment., • Strong understanding of GMP, GDP, GCP, DSCSA/EPCIS, ICH guidelines, and clinical supply chain processes., • Experience with deviations, CAPA, change control, labeling review, packaging operations, and QA release. Preferred Qualifications • Experience working with temperature-controlled logistics (2–8°ree;C, -20°ree;C, CRT)., • Knowledge of comparator sourcing workflows and global distribution practices., • Familiarity with Quality Agreements, Supplier Qualification, and Vendor Audits., • Experience with Power BI, SharePoint QMS, and ERP/WMS systems., • Certification in GMP/GDP/GCP (optional but advantageous). Core Competencies • Strong attention to detail and documentation accuracy., • Excellent communication and problem-solving skills., • Ability to work cross-functionally and manage multiple priorities., • Proactive, organized, and committed to quality and compliance., • Ability to make decisions based on risk, data analysis, and regulatory expectations. Why Join Jupiter Research Services? • Work in a rapidly growing organization focused on resilient clinical supply chain solutions., • Gain exposure to global clinical trials, high-impact projects, and innovative supply models., • Contribute to a compliance-driven organization with strong customer and patient-centric values., • Opportunities for growth in Quality, Operations, Regulatory, and Project Management.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. Job Title: Customs Trade Compliance Expert This position is based fully fully remote. The salary range is approximately $85,000 - $105,000 based on experience. Responsibilities: • Ensure adherence to all applicable import/export and PGA requirement and regulations, including CFR, HTSUS, U.S. Export Administration Regulations (EAR), International Traffic in Arms Regulations (ITAR), and other international trade laws., • Act as the primary point of contact for customs clearance processes., • File entries through the Automated Broker Interface (ABI) in compliance with CBP regulations., • Supervise classification processes for Harmonized Tariff Schedule (HTS), Schedule B, ECCN, and Harmonized System Codes (HSC) to ensure compliant imports/exports and maximize duty savings., • Establish and lead Duty Drawback Program., • Apply and maintain company Import and Export Licenses and Permits., • Interpret import/export regulations, rulings, and trade documentation., • Conduct compliance audits to ensure full regulatory compliant with accurate filings and duties, and lead corrective action plans resulting from audits and compliance issues., • Coordinate release and delivery of shipments with customs, freight forwarders, carriers, and warehouses., • Address any customs-related issues such as holds, inspections, and compliance reviews., • Maintain required documentation for audit readiness and CBP recordkeeping requirements (19 CFR)., • Collaborate with internal and external teams to provide customs guidance and operational support., • Stay current with regulatory changes from CBP and Partner Government Agencies (PGA) such as FDA, USDA, EPA, FWS, CDC and more., • Train and support team members in customs procedures, filing practices, and import/export compliance., • Stay updated on changes to import/export laws and regulations in countries where the company operates., • Identify and address risks related to trade compliance, including restricted-party transactions and violations of trade law., • Investigate and report trade compliance incidents, and implement corrective actions. Requirements: • U.S. Customs Broker License or CCS or CES certified with Duty Drawback program setup experience, • Minimum 5+ years of experience in trade compliance with special focus in duty drawback, • Solid knowledge of Import/Export Regulations and Product Classification., • Proven expertise in U.S. import/export procedures and regulatory environments., • Strong working knowledge of ACE, ABI systems, and classification tools., • Excellent attention to detail, accuracy, and time management., • Ability to communicate professionally with clients, vendors, and government agencies., • Proficiency in MS Office Suite and customs brokerage software (e.g., Mercury/ITS, CargoWise, Descartes, etc.). Preferred Qualifications: • Ability and success tracking records of establishing and maintaining a successful Duty Drawback program, • Experience of filing import entries using ABI-approved vendor portal., • Background in customs audits or post-entry corrections (e.g., PSC, protests). #LI-EB1 #GS GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job Description About Spectrum Vascular Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset. Role Description: The Director, Regulatory Affairs is responsible for leading and executing regulatory activities to support global product registrations and lifecycle compliance for the company's medical device portfolio. This role combines strategic oversight with hands-on regulatory execution, including direct authorship of complex submissions (e.g., 510(k)s), regulatory assessments, and agency interactions. This individual serves as a key regulatory lead within cross-functional teams and is accountable for ensuring that regulatory requirements are effectively translated into actionable plans and deliverables across the product lifecycle. Key Responsibilities • Serve as the regulatory lead for product development and lifecycle management, providing both strategic direction and hands-on execution of regulatory deliverables., • Author, review, and finalize regulatory submissions (e.g., 510(k), PMA, international dossiers), ensuring high-quality, technically sound, and compliant submissions., • Lead preparation and management of U.S. FDA and global regulatory submissions, including direct interaction with regulatory authorities and notified bodies., • Drive regulatory strategy development for new products, product changes, and global market expansion, while ensuring alignment with business objectives., • Act as the primary regulatory representative on cross-functional teams, influencing decisions related to product design, claims, testing, and labeling., • Evaluate and interpret regulatory requirements, guidance documents, and regulatory intelligence, translating them into actionable plans., • Provide expert regulatory input into design control, risk management (ISO 14971), clinical, and preclinical activities to support submissions and compliance., • Assess the regulatory impact of product and process changes, and define appropriate submission strategies or justification for non-submission., • Lead and support regulatory agency interactions, including pre-submissions, deficiency responses, and meeting preparation., • Ensure timely responses to regulatory inquiries and manage commitments to regulatory bodies., • Oversee and contribute to labeling and promotional material review to ensure compliance with applicable regulations and approved claims., • Provide regulatory leadership in quality system activities, including CAPAs, nonconformances, field actions, and change control., • Support and participate in audits and inspections (FDA, Notified Bodies), including preparation and response activities., • Mentor and provide guidance to junior regulatory staff, while remaining actively engaged in execution., • Contribute to the development and continuous improvement of regulatory processes, SOPs, and internal best practices. Competencies • Demonstrated ability to operate at both strategic and tactical levels, with strong execution focus, • Deep technical expertise with the ability to independently author complex regulatory submissions, • Strong analytical and problem-solving skills, with the ability to navigate ambiguous regulatory pathways, • Effective communicator with the ability to influence cross-functional stakeholders and senior leadership, • High attention to detail with a consistent focus on quality and compliance, • Ability to manage multiple priorities and adapt in a fast-paced, evolving regulatory environment, • Proven leadership capability, including mentoring and guiding team members Qualifications • Bachelor's degree (B.S. or B.A.) in Engineering, Life Sciences, or related field required, • 8–10+ years of regulatory affairs experience in an FDA-regulated industry (medical device preferred), • Demonstrated hands-on experience authoring and leading 510(k) submissions, • Strong knowledge of FDA regulations, global regulatory frameworks, and medical device requirements, • Experience interacting directly with FDA and Notified Bodies, • Solid understanding of design controls, product development, and lifecycle management, • Advanced degree preferred Work Environment: · Dynamic, interactive, fast-paced, and entrepreneurial environment · Travel – up to 25%??, additional may be required during execution of validation activities Spectrum Vascular is an Equal Opportunity Employer and committed to creating a diverse and inclusive company culture. Spectrum Vascular does not discriminate against candidates and employees because of their disability, sex, race, gender identity, sexual orientation, religion, national origin, age, veteran status, or any other protected status under the law.

Job DescriptionJob Description We are seeking an experienced Import Customs Clearance Specialist to file customs entries in full compliance with U.S. Customs and Partner Government Agency regulations. The ideal candidate will have strong attention to detail, excellent communication skills, and hands-on experience handling customs entries and import documentation in a fast-paced environment. Key Responsibilities · Prepare, review, and submit import customs entries to U.S. Customs and Border Protection (CBP) · Coordinate filings with Partner Government Agencies (FDA, USDA, EPA, Fish & Wildlife Service, etc.) · Transmit customs entries accurately and within regulatory deadlines · Review commercial invoices, packing lists, bills of lading, and related documents for accuracy and compliance · File Importer Security Filings (ISF) and monitor compliance timelines · Receive, review, and process import documentation for assigned accounts · Track and trace shipment documentation (HBLs, invoices, supporting records) · Communicate with customers, overseas agents, freight forwarders, carriers, steamship lines, airlines, trucking companies, and government officials · Resolve customs-related issues including documentation discrepancies, customs exams, FDA holds, and clearance delays · Provide timely updates to internal teams and external customers · Deliver excellent customer service while maintaining compliance with all applicable laws and regulations. Qualifications & Experience · 2–5 years of experience in import customs clearance or international trade operations · Strong knowledge of U.S. Customs regulations and the Harmonized Tariff Schedule (HTS) · Familiarity with Partner Government Agencies (FDA, USDA, EPA, FWS) is a plus · Ability to work independently, multitask, and thrive in a fast-paced environment · Strong problem-solving skills and attention to detail · Excellent written and verbal communication skills · Proficiency in Microsoft Outlook, Excel, Word, and Cargowise (CW1) · Team-oriented, customer-focused mindset. Compensation & Benefits Competitive salary of $55,000–$65,000 annually, based on experience. Opportunities for professional growth and development

Job Description Job Description Date 2026 Location 1200 Airport Road, North Brunswick NJ Title Senior Manager, R&D Department Research & Development Reports to VP, Research & Development FLSA (Exempt or Non-Exempt Exempt Role Overview The Senior Manager, R&D will lead multiple product development programs through the research, scale-up, and commercialization process while ensuring adherence to cGMPs, SOPs, FDA requirements, and customer expectations. This individual will provide technical and managerial leadership to the R&D team, oversee development priorities, manage complex projects, and partner closely with Production, Quality, Regulatory, Procurement, and Commercial teams. The Senior Manager, R&D will play a critical role in building and executing integrated development plans, improving department capabilities, mentoring team members, and supporting the company’s strategic growth and innovation initiatives. The duties and responsibilities described are not limited to those outlined and are not intended to be a comprehensive list of all activities, functions, or responsibilities required of the position. Additional duties and responsibilities may be assigned as required. This position requires travel for customer visits and trade shows, both within the United States and internationally, as needed to support business objectives. Areas of Responsibility Leadership & Strategy • Lead and manage the R&D function for new product development, reformulations, and line extensions., • Supervise, coach, and develop a team of formulation scientists, chemists, and R&D associates., • Establish department priorities, allocate resources, and ensure project timelines are achieved., • Collaborate with senior leadership to define product strategy, innovation pipeline, and technical direction., • Drive continuous improvement initiatives related to product development, manufacturing processes, and departmental efficiency., • Serve as the technical lead and subject matter expert for formulation and process development activities. Product Development & Commercialization • Oversee development and commercialization of nutraceutical products including capsules, tablets (monolayer, bilayer, trilayer), beadlets, powders, stick packs, and other specialty dosage forms., • Develop robust formulations and scalable manufacturing processes for dietary supplements and nutraceutical products., • Research and evaluate new ingredients, technologies, excipients, delivery systems, and product claims., • Lead feasibility assessments, prototype development, and technical evaluations for new business opportunities., • Design and direct laboratory experiments, pilot studies, and process optimization activities., • Recommend alternative ingredients and/or process improvements to enhance product quality, manufacturability, cost, and efficiency., • Scale up pre-exhibit and exhibit batches to commercial manufacturing and lead technology transfer from R&D to Production., • Coordinate manufacturing start-up activities and provide floor support during scale-up and initial production runs. Regulatory, Compliance & Documentation • Ensure all product development activities comply with applicable SOPs, FDA regulations, dietary supplement regulations, and Current Good Manufacturing Practices (cGMPs)., • Create, review, and approve SOPs, technical documents, formulas, specifications, validation protocols, and product development reports., • Review batch records, process characterization studies, validation reports, deviations, CAPAs, and investigation reports., • Prepare and review technical briefs, ingredient specifications, risk assessments, and customer-facing development summaries., • Support internal and external audits, customer visits, and regulatory inspections., • Maintain accurate and complete project documentation in accordance with company standards. Cross-Functional Collaboration • Partner closely with Production, Quality Assurance, Quality Control, Regulatory Affairs, Procurement, Supply Chain, Sales, and Marketing teams., • Present technical findings, risks, recommendations, and project status updates to cross-functional teams and leadership., • Identify and proactively communicate development risks, technical issues, and timeline impacts., • Work with vendors and suppliers to identify and qualify new raw materials and technologies., • Support business development and customer meetings by providing technical expertise and formulation recommendations. Additional Responsibilities • Monitor industry trends, emerging ingredients, formulation technologies, and competitive products., • Develop and manage project timelines, budgets, and department metrics., • Assist with annual planning, capital requests, and staffing needs for the R&D department., • Perform other duties and special projects as assigned. Other Responsibilities Including Safety: • Comply with all job-related safety and other training requirements. Requirements Education & Qualification: • Master’s degree in Pharmaceutical Sciences, Chemistry, Food Science, Chemical Engineering, or a related scientific discipline required., • OR a combination of education and experience equivalent to the above requirements., • 8–12+ years of progressive experience in product development, formulation, and commercialization within the nutraceutical, dietary supplement, pharmaceutical, or CDMO industry., • Minimum 3–5 years of leadership or people management experience., • Strong experience with tablets, capsules, powders, beadlets, and related dosage forms., • Proven experience in scaling products from laboratory through commercial manufacturing., • Experience working in a fast-paced contract manufacturing or CDMO environment strongly preferred. Certifications, Licenses, Credentials: • N/A Skills & Ability • Thorough understanding of cGMPs, FDA regulations, dietary supplement regulations, and product development processes., • Strong technical knowledge of formulation science, process development, scale-up, and manufacturing., • Excellent leadership, coaching, and project management skills., • Strong analytical and problem-solving abilities with the ability to interpret complex technical data., • Excellent written and verbal communication skills., • Ability to manage multiple projects simultaneously and meet aggressive timelines., • Strong organizational and cross-functional collaboration skills., • High level of ethics, integrity, professionalism, and confidentiality., • Proficient in Microsoft Office and ERP/document management systems.Able to maintain a professional and positive attitude., • Able to maintain confidentiality and possess a high level of ethics and integrity. Physical Requirements (lifting, etc.): • The employee is frequently required to sit (50%), stand, and walk (50%). Uses hands to finger, handle or feel writing tools and computer keyboard. May reach with hands and arms and infrequently may lift up to 30lbs. Use desk telephone/cell phone to talk and hear or converse with other employees. Work Environment (Office, Warehouse, temperature extremes, etc.): • Primarily located in an office environment where temperatures are controlled for heat and air conditioning. Occasionally walks through warehouse or manufacturing workplace and will be required to wear appropriate PPE for each work area including safety shoes, hair net, safety glasses, face mask, gloves, or disposable jumpsuit. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including medical, dental, vision, short- and long-term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation in the first year, which grows to 12 days starting the second year of employment. Job Description Acknowledgement I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodation.

In this high-impact consulting role, the Regulatory Medical Writer will provide expert-level authoring and regulatory documentation support across a range of FDA NDA submission programs. Collaborate cross-functionally with clinical development teams, biostatistics, data management, pharmacovigilance

Experience in Animal Health or Pharmaceutical supply chain management. Knowledge of supply chain tools and business processes. Animal Health/Pharmaceutical industry and supply chain experience in direct operations, and familiarity with FDA and other regulatory requirements.

Novo Nordisk in Plainsboro Township, NJ, is searching for a Head of Regulatory Affairs to lead and define the strategic agenda for the Regulatory Affairs team. The role entails managing product submissions and approvals, engaging with the FDA, and developing innovative regulatory strategies.