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Job Description SOKOL GxP Services is seeking a QA Label Control Specialist (2nd Shift) to support our client’s Cell Therapy Manufacturing facility in Summit, NJ. In this role, you will execute label control, issuance, and printing activities to ensure compliance with FDA, cGMP, and internal quality standards for clinical and commercial cell therapy products. You will be responsible for preparing, verifying, and issuing in-process and final product labels, maintaining documentation accuracy, and supporting inspection readiness. This position collaborates closely with Manufacturing, Quality Assurance, Quality Control, and CTDO operations to ensure timely label delivery and error-free execution of GMP processes. This is an excellent opportunity for someone with hands-on labeling experience in a regulated biopharmaceutical environment, strong documentation discipline, and the ability to work independently on a fast-paced shift supporting patient-critical therapies. Requirements Education & Experience • Bachelor’s degree in a scientific discipline (Biology, Chemistry, or related field) – U.S. degree required, • 1+ years of labeling experience in a cGMP/FDA-regulated biopharma environment, • 1+ years of Quality experience, • 1+ years of U.S. biopharmaceutical manufacturing or QA operations experience, • 3+ years of experience using MS Office 365 (Excel, Teams, SharePoint in project/document control settings)Technical Skills, • Experience in label issuance, printing, verification, and reconciliation, • Familiarity with labeling systems; Crystal Reports or BarTender preferred, • Hands-on use of document management systems (e.g., Veeva, MasterControl, Documentum), • Understanding of change control, deviations, CAPA, investigations, and quality systems, • Ability to write, revise, and maintain SOPs, work instructions, and technical documentationCore Competencies, • Strong understanding of GMP, compliance, and data integrity, • High attention to detail and accuracy in all documentation, • Ability to recognize issues, escalate appropriately, and propose solutions, • Excellent communication and customer service mindset, • Ability to work independently on shift while collaborating with cross-functional teams, • Ability to support internal and health authority inspections through accurate documentation and retrieval, • Strong time-management skills with the ability to handle multiple priorities, • Advanced computer proficiency and comfort working within electronic systemsKey Responsibilities, • Issue and print clinical and commercial labels for manufacturing and packaging, • Ensure labels meet all regulatory and internal quality requirements, • Coordinate with production to support timely and accurate label availability, • Support document accuracy, label reconciliation, and tracking activities, • Maintain and update SOPs, label control procedures, and documentation, • Provide training for personnel on label issuance processes, • Support audits, inspections, and quality investigations as required Competitive hourly rate: $27.52 – $34.96/hr (W-2 only, no C2C). Working Hours: 2nd Shift , Wed-Sat - 4pm-2am. 6-month contract with possibility of extension or conversion for the right candidate depending on performance. Health insurance, holiday pay, 401(k) program, and other benefits. Employee referral bonus program.

Job Description ABOUT ORGANOX: OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally. Position Summary The Engineering Director – Product Engineering position oversees project management and addresses supply and design-related matters for the released portfolio of OrganOx Normothermic Machine Perfusion (NMP) products, currently the ‘metra’. The metra device is a medical system integrating multiple engineering disciplines, utilizing both capital equipment and disposable components to support liver transplants and improve organ availability. Responsibilities include developing new features within the lifecycle management of the current product range. This role involves leading cross-functional teams to identify issues, develop corrective action plans, and implement solutions related to both technical product matters and broader product development challenges. This position requires interaction with upper management for project reporting and phase reviews. The role encompasses experience with various therapies, products, and operational considerations connected to patient care and business objectives. This is a full-time role in Madison, NJ, with extensive collaboration with colleagues based in Oxford, UK. Major Responsibilities As the leader of a small multi-disciplinary Product Engineering team, and under the direction of the SVP, Product Engineering, the successful incumbent will drive activities in the following areas: • Lead cross-functional team members to ensure clear communication and coordination of project/program objectives, deliverables, and timing of key milestones., • Orient quickly to understand new quality issues based on field or factory performance, and to concurrently manage multiple projects with different teams and while balancing competing priorities., • May take direct responsibility for design-related CAPAs (Corrective and Preventive Action) within the Product Engineering department as well as process focused CAPAs., • Author investigation (i.e., root cause analysis) plans, reports, and supporting documents of high quality (i.e., submission and audit/inspection ready) that are technically sounds, critically reasoned, and use appropriate root cause tools/methodologies (e.g., 5-Whys/Cause Map, Contradiction Matrix, other DRM/Six Sigma problem-solving and statistical analyses)., • Provide clear and concise communication – both written and verbal. Author strong documentation with attention-to-detail that is audit-ready. Present team’s investigation findings and action recommendations to quality (e.g., CAPA Board) and other management/business stakeholders., • Plan schedule and resources (e.g., labor skills sets and duration, expenses) to achieve desired project outcomes., • Responsible for maintaining a focus on quality, while effectively partnering with Quality, R&D, Operations, and Regulatory stakeholders to facilitate consensus, resolve disagreements, and ensure sound decision-making., • Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies Requirements Skills & Experience • Experience in medical device or highly regulated industry., • Experience or technical education in software development, software or computer engineering, and/or software quality assurance, including knowledge of IEC 62304 (Medical device software – software life cycle processes)., • Experience with medical device systems that include software applications and/or embedded software (i.e., firmware)., • Experience leading a complex project/program including cross functional team leadership, risk-based decision making, financial accountability, and ability to manage change implementation., • Background with CAPA (Corrective and Preventive Action) process, and/or experience with the use of root cause investigation, problem-solving, or similar structured methodologies and tools (e.g., 5-Whys, Fishbone, etc.), • Experience participating in or supporting audits or external inspections (e.g., FDA, TUV, internal audit)., • Proven experience in achieving results through influence management and motivating teams., • Knowledge and/or experience with product development processes and/or QMS (Quality Management System) Design Control procedures., • Strong understanding of global regulatory requirements for medical devices, including FDA regulations (e.g., 21CFR Part 820), ISO 13485, Medical Device Directive, and European Medical Device Regulation., • Working knowledge of Project Management methodologies and tools, including Project Management Professional (PMP) trained or certified Qualifications • Requires a bachelor’s degree in engineering and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience., • Certified practitioner in Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), or Lean Sigma methodologies., • Ability to travel 15% A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate. Benefits We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Job Description OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 12 hours, significantly reducing organ discard rates and facilitating more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion in North America, we seek a motivated and strategic Supply Chain Operations Specialist to join our team. The Logistics Specialist is responsible for processing customer orders and returns, coordinating domestic and international shipments, creating shipping documentation, return requests, order acknowledgments, and sales quotations in SAP. This role also supports continuous process improvement initiatives to optimize logistics efficiency, compliance, and customer satisfaction. Key Responsibilities • Process customer orders in a timely and accurate manner to maintain an outstanding service level for all customers., • Maintain positive and professional relationships with all customers, third-party logistics (3PL) providers, and carrier partners., • Coordinate both domestic and international shipments, ensuring full compliance with shipping regulations, Incoterms, and customs documentation requirements., • Serve as a key point of contact for all logistics-related issues, resolving them promptly and efficiently., • Manage the Return Material Authorization (RMA) process for the return of products from customers to OrganOx Inc. (U.S.) and OrganOx Ltd. (U.K.)., • Create order acknowledgments, delivery notes, stock transfers, return requests, and sales quotations in SAP., • Collaborate with cross-functional teams and Operations leadership to ensure timely and accurate delivery of products and services., • Monitor logistics workflows and recommend process improvements to enhance efficiency and reduce cost., • Report customer sales, returns, and shipment data on a weekly and monthly basis using SAP and Excel reporting tools. Skills & Experience • Minimum of 3 years of experience in logistics and international shipments, including knowledge of:, • Incoterms and their application in international trade, • Customs clearance procedures and import/export documentation, • Commodity codes / Harmonized Tariff Schedule (HTS) classification, • Import/export regulatory compliance (e.g., FDA, CBP, as applicable), • Previous experience in the medical device or life sciences industry preferred., • Experience with SAP or a similar ERP system., • Strong attention to detail and organizational skills., • Excellent communication skills (written and verbal) for liaising with customers, carriers, and internal teams., • High level of problem-solving and analytical skills., • Proficiency in Microsoft Outlook, Excel, and Word., • Ability to work independently and manage multiple priorities in a fast-paced environment., • Adaptable and proactive in a continuously evolving global logistics landscape. Work Environment • Prolonged periods of sitting at a desk and working on a computer., • Standard 40-hour work week applies., • Weekend availability may be required for urgent orders (less than 10%). Qualifications • Minimum of 3 years’ experience in a similar logistics or supply chain role, with emphasis on international shipments., • Experience with SAP or equivalent ERP software., • Experience managing the RMA process., • Demonstrated attention to detail and strong organizational capabilities. A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate. We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview The Director, Commercial Finance will be responsible for driving financial performance and strategic decision-making across the commercial functions of the pharmaceutical business. This role involves leading financial planning, gross-to-net (GTN) analysis, inventory management, budgeting processes, and new system implementation. The successful candidate will work closely with cross-functional teams, including Sales, Marketing, Supply Chain, and Operations, to ensure financial health and sustainable growth. Essential Duties • Commercial Finance Leadership, • Provide financial leadership to commercial teams, ensuring alignment with business objectives., • Develop and implement financial strategies to support revenue growth, profitability, and cost efficiency., • Partner with commercial teams to analyze business performance, pricing strategies, and margin improvements., • Gross-to-Net (GTN) Analysis & Revenue Management, • Oversee GTN calculations, ensuring accurate revenue recognition and reporting., • Monitor and evaluate rebate programs, discounts, and other commercial deductions., • Provide insights into pricing and contract strategies to optimize net revenue., • Develop robust GTN forecasting models to improve accuracy and decision-making., • Inventory Management & Supply Chain Finance, • Oversee inventory valuation, ensuring compliance with financial reporting standards., • Optimize inventory levels to balance demand, working capital, and cost efficiency., • Work closely with Supply Chain and Operations to drive efficiency in inventory turnover., • Implement controls to mitigate inventory risks, obsolescence, and write-offs., • Financial Planning, Budgeting & Forecasting, • Lead annual budgeting and periodic forecasting processes for commercial functions., • Develop financial models to assess business scenarios, risks, and opportunities., • Track performance against budgets and forecasts, providing variance analysis and recommendations., • Collaborate with business leaders to ensure financial targets are met., • New System Implementation, • Lead the implementation of new financial and operational systems to enhance efficiency and reporting capabilities., • Work with IT and business stakeholders to ensure smooth transition and integration of new systems., • Provide training and support to commercial finance teams on new tools and processes., • Ensure data integrity and compliance throughout the implementation process., • Business Partnering & Stakeholder Management, • Act as a key financial advisor to the executive leadership team., • Work closely with Sales and Marketing teams to assess market opportunities and profitability., • Collaborate with external auditors, tax advisors, and regulatory bodies as required., • Strong understanding of GTN, inventory management, budgeting, and financial planning in a pharma setting., • Experience leading financial system implementations and process improvements., • Expertise in financial modeling, data analytics, and strategic financial planning., • Strong leadership skills with experience managing teams and cross-functional partnerships., • Excellent communication, stakeholder management, and problem-solving abilities., • Bachelor's degree in Finance, Accounting, Economics, or a related field (MBA or CPA preferred)., • CPA preferred Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $150,000 to $240,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

Job Description WSA is a global leader in the hearing aid industry. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world. Our portfolio of technologies spans the full spectrum of hearing care, from distinct hearing brands and digital platforms to managed care, hearing centers and diagnostics locations. * Office location - Iselin, New Jersey (hybrid) * Base range - 70,000 - 90,000 ESSENTIAL DUTIES AND RESPONSIBILITIES: * Serve as part of the America’s DCU working in a Global and multicultural Team that ensures customer complaints are captured, assessed for reportability, processed and resolved in a timely manner as per applicable internal and regulatory requirements. * Perform initial screening of new complaints to determine potential reportability, investigator and appropriate investigation location. Process local device return logistics for complaint handling. * Perform follow-ups with investigators, LPOC’s and other partners to ensure complaints are processed in a timely manner. * Continuously review complaint files to ensure documentation is aligned according to requirements (internal/external) and good documentation practices. * Perform final review of complaint files to ensure all activities were completed and documented accordingly. * Provide input on Global Projects and process improvements related to complaint handling. * Provide support for stakeholders and ensure that Global complaint process inspections and audits (internal and external) are effectively managed. * Serve as a contact person to local Customer Service, Affiliates and LPOC’s to ensure all appropriate complaint information is received for day-to-day complaint handling. * Be available for early morning calls with global Team 1-2x per month. REQUIREMENTS: * Bachelor’s degree required * Experience or knowledge with Complaint Handling processes and associated standards and regulations (FDA, ISO 13485, CFR, GMP, etc.) preferred * Proficient with Microsoft Office tools (Excel, PowerPoint, Word). * Salesforce and/or Complaint Management System experience preferred * Possess leadership capabilities * Strong problem-solving and time management skills * Team player * Ability to work independently The Company provides equal opportunity to all employees and prospective employees without regard to race, color, creed, religion, national origin, ancestry, sex, age, physical or mental disability, marital status, pregnancy, genetic information, sexual orientation, gender identity, protected veteran or military status, or any other consideration not related to the person’s ability to do the job or otherwise made unlawful by federal, state, or local law.

Job Description Salary: 92500 to 108000 Other Forms of Compensation: What makes FLIK click What makes FLIK click? Our people. The decisions, actions and attitudes of our associates earn the trust and loyalty of our clients every day. We know how to pick them and we know how to grow them. It starts with hiring people who share our passion for food and hospitality. Once we find the right talent, we encourage, value and recognize their contributions. We keep our people renewed, excited and engaged by providing hands-on training and educating them about the latest trends. We give them a stake in successfully raising the bar. Our people love what they do and they love sharing their passion. Join our team and see the FLIK difference. Where a job isn’t merely a job but the start of a career where you can flourish. Job Summary Director of Operational Excellence – FLIK Hospitality Group (Merck Account) Position Summary The Director of Operational Excellence serves as the primary steward of food, service & quality standards across all FLIK-managed Merck locations. This role ensures full compliance with Merck, Compass Group, and requirements, maintaining a culture of excellence, accountability, and continuous improvement. The Director of Operational Excellence will oversee Service and food programs, manage internal audits, and partner closely with operations, culinary, and client representatives to ensure all dining and catering operations meet or exceed expectations. Key Responsibilities Food Safety, Compliance & Documentation • Develop, implement, and manage a comprehensive QA program across all Merck campuses (e.g., Rahway, West Point, Upper Gwynedd, Boston, Durham, Wilson, South San Francisco, Dakin House, Canada)., • Ensure strict compliance with FDA, USDA, Compass Group, and local Board of Health requirements., • Oversee HACCP documentation and verification through the Plumsense platform, ensuring all logs, temperature records, and corrective actions are completed accurately and on time., • Maintain and update QA documentation for client review, including site-specific compliance reports and inspection summaries., • Conduct scheduled and unannounced QA audits across all café, catering, and conference operations, including storage, prep, and service areas., • Partner with Merck EHS and Board of Health representatives during inspections to ensure prompt corrective actions and transparent communication., • Lead quarterly site-level verification reviews aligned with KPI reporting and SLA requirements. Training & Continuous Improvement • Develop and deliver ongoing training for management and hourly associates on ServSafe, HACCP, sanitation, allergen awareness, and proper food handling., • Reinforce daily operational standards through pre-shift huddles, spot checks, and one-on-one coaching., • Partner with site leadership to drive a proactive approach to safety and quality—reducing reactive incidents and improving audit scores. Product Quality & Vendor Assurance • Verify that all incoming food and beverage products meet approved vendor and Merck specifications., • Participate in menu reviews and new product introductions to ensure compliance with allergen, nutritional, and labeling requirements. Client Engagement & Reporting • Serve as the QA liaison between FLIK Hospitality and Merck client leadership, providing transparency and proactive updates., • Prepare monthly and quarterly QA performance summaries for internal and client review., • Partner with the FLIK leadership team to support KPI documentation, audit results, and compliance reports within the Service Level Agreement (SLA) framework. Qualifications • Education & Experience, • Bachelor’s degree in Food Science, Nutrition, Microbiology, Hospitality Management, or a related field., • Minimum of 5 years of experience in Quality Assurance or Food Safety management within a multi-site foodservice, healthcare, or corporate dining environment., • HACCP Certification recognized through the International HACCP Alliance – required., • ServSafe Manager Certification – required., • Experience with Compass Group QA systems (e.g., Plumsense, Eatec, iAuditor, SafetyCulture) preferred., • Skills & Competencies, • In-depth understanding of HACCP principles, FDA Food Code, GMPs, and SSOPs. Apply to Flik today! Flik is a member of Compass Group USA Click here to Learn More about the Compass Story Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law. Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act. Applications are accepted on an ongoing basis. Flik maintains a drug-free workplace. Associates at Flik Hospitality are offered many fantastic benefits. • Medical, • Dental, • Vision, • Life Insurance/ AD, • Disability Insurance, • Retirement Plan, • Paid Time Off, • Holiday Time Off (varies by site/state), • Associate Shopping Program, • Health and Wellness Programs, • Discount Marketplace, • Identity Theft Protection, • Pet Insurance, • Commuter Benefits, • Employee Assistance Program, • Flexible Spending Accounts (FSAs), • Paid Parental Leave Req ID: 1478823 Flik Hospitality Group Shane Tirpak [[req_classification]]

Job Description Hi, we're Nuts.com! Nuts.com is a self-funded, profitable, rapidly growing multi-channel DTC specialty food and wellness company with over 550 people on our team. We're changing the landscape of snacking on nuts, dried fruit, chocolate and more! We planted our roots in Newark, New Jersey during the Great Depression, selling premium nuts on Mulberry Street's open-air market. We've come quite a long way since then, taking our multi-generational family business online in 1999. Even after 96 years, we continue to pride ourselves in expertly sourcing the highest quality foods and treating our customers like family. What's our team like? We're driven, collaborative and entrepreneurial. Energy and passion power our business and we look for candidates who share in that excitement to help us continue to build something special. The role: The Quality Assurance Manager will be responsible for developing, implementing, and maintaining robust food safety and quality management systems that strictly comply with all regulatory requirements and company standards. Success in this role demands a professional who thrives in a fast-paced food manufacturing environment, spending the majority of your time directly on the production floor. The ideal candidate will have demonstrated experience with food quality and safety systems, including Good Manufacturing Practices (GMP) compliance, FDA Food Safety Modernization Act (FSMA), comprehensive record-keeping/documentation, employee training, problem-solving skills and change management within a food processing environment. This position reports directly to the Director of Food Safety and Quality Assurance. In the absence of the Quality Assurance Manager the Food Safety & Regulatory Compliance Manager will act as a back up. What you'll do: Food Quality Assurance & Compliance • Ensure all manufacturing processes, raw materials, packaging, work-in-process (WIP), and finished products consistently meet internal quality standards, regulatory requirements (e.g., FDA FSMA), and recognized food safety certifications (e.g., HACCP, GFSI, SQF, Gluten-free, Organic, Non-GMO, Kosher)., • Lead root cause analysis investigations for food safety and quality deviations, implementing effective Corrective and Preventive Actions (CAPAs)., • Manage internal and external food safety and quality audits, ensuring audit readiness and compliance., • Own and drive improvements in customer complaints metrics directly related to product quality and food safety., • Ensure the seamless integration and coherence of established Food Safety and Quality Assurance (FSQA) programs with on-floor operational processes., • Provide dedicated oversight for critical processes, including Allergen Control, Hygienic Zoning, Pest Control, GMP Audits, KPIs, Sanitation support, Pre-Operational Inspections, Line Changeovers, Line Clearances, Quality-focused Inventory Audits, Production Line Audits, and Fulfillment Audits., • Manage and drive improvements in Material Review Board (MRB) processes., • Create, maintain, and manage comprehensive food safety and quality documentation., • Develop and deliver comprehensive training programs for production staff and management on food safety, SQF system, quality assurance principles, GMPs, and revised procedures., • Actively participate in and lead continuous improvement initiatives focused on enhancing food safety, food safety culture, quality, and operational efficiency within quality assurance., • Analyze existing food safety and quality processes to identify opportunities for optimization and waste reduction., • Play a key role in food safety and quality improvement projects, ensuring timely completion., • Lead, mentor, and develop a team of Quality Assurance associates, championing their professional growth and fostering a highly engaged environment., • Step in and assist with other quality roles as necessary to ensure smooth operations. What you'll bring: • Bachelor's degree in Food Science, Engineering, or a related scientific discipline preferred., • 5+ years of progressive experience in food quality assurance or food safety management within a food manufacturing facility., • Demonstrated experience with internal and external audit compliance (e.g., GFSI standards, FDA, FSMA, Organic)., • Certifications in Internal Auditing, HACCP and PCQI are required; SQF Practitioner or BRC Lead Auditor certification is a significant plus., • Strong knowledge of FDA regulations (e.g., FSMA) and other relevant food safety guidelines., • Proficiency with Electronic Quality Management Systems (EQMS)., • Experience with Lean Six Sigma, 5 Whys, and Pareto analysis is highly desirable., • Self-motivated, proactive, and possessing a strong business acumen with the ability to navigate challenging situations independently., • Knowledge of OSHA protocols in a manufacturing environment., • Bilingual - Spanish is strongly preferred. What we offer • A high-growth and rewarding role in a foundationally strong and rapidly evolving business, • Annual Salary Range: $100,000 - $110,000 plus annual bonus, • Excellent benefits including a 401K Match, • Paid Maternity, Adoption and Paternity leave, • And all the Nuts.com snacks your heart desires + a 40% employee discount EEO STATEMENT Nuts.com is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, immigration status, age, sex or gender (including pregnancy), gender identity or expression (including transgender status), sexual orientation, marital status, veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Applicants with disabilities who require assistance or accommodation during the application or interview process should reach out to us at

Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview Tonix is looking for a full-time Senior Director of Program and Portfolio Management (PPM) to effectively shape and implement PPM strategies decision making for a complex portfolio of drug development programs and execution of decisions. The Senior Director of PPM will be a responsible for implementing portfolio management best practices, drafting strategic and operational plans, mentoring project managers (PM) and operational staff, and supporting effective communications across multiple departments at Tonix. The individual in this position will also be responsible for building out the team of PMs which would report into this role. This is a fast-paced, challenging position offering a competitive compensation and benefits package. This position will report directly to the Company’s Chief Operating Officer that will ideally be based at the Tonix Chatham, NJ office. Essential Duties • Lead and manage cross-functional teams interacting with clinical, nonclinical, regulatory, CMC, discovery, and others to set priorities, work toward goals and monitor progress of programs, • Develop portfolio tools and materials to support portfolio decision-making, • Create, implement, and refine PPM practices to support leadership, PPM staff, and delivery of program goals, • Lead regular portfolio operations committee meetings and portfolio strategy sessions, • Coordinate and manage due diligence teams and decision making on in licensing activities for the portfolio, • Help to buildout and lead PMs responsible for developing cross-functional program plans, timelines, and budgets in collaboration with functional area leads, • Facilitate effective, science-based business decisions including development of scenarios and strategic impact of decisions, • Ensure all decisions are assessed as to their risks and impacts as well as accountable for communication to team and stakeholders in a transparent and timely manner, • Function as an integrator within the project team and across the Company to ensure alignment, • Develop and coordinate resource and budget planning activities across functions to ensure adequate resources are applied to the programs and decisions are assessed for portfolio impact, • Provide leadership to teams and functional areas to proactively anticipate and identify project issues which pose a challenge to achieving strategic goals; propose and implement plans to resolve such issues, and execute corrective actions, • Effectively execute change management to implement strategies for effecting, controlling, and helping teams adapt to change, • Provide updated project information for the Board as well as for regular budget and portfolio reviews, • Enable high-performing teams by ensuring good team dynamics within the project team, • Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s), • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork, • Recruits, interviews, hires, and trains new team members, • Oversees the daily workflow of the department, • Provides constructive and timely performance evaluations, • If necessary, handles discipline and termination of employees in accordance with company policy, • Bachelor’s degree and fifteen (15) years of relevant project / program / portfolio management experience within the pharmaceutical / biotechnology industry; or a PhD in a scientific field or a PharmD, DVM or MD degree with ten (10) years of relevant experience preferred, • Scientific background and/or MBA preferred, • Ten (10) years of leading cross-functional program or portfolio management activities within the pharmaceutical industry with a deep understanding of practices and standards of pharmaceutical program and portfolio management preferred, • Experience managing PM professionals in the drug development industry, • Strong leadership presence with the ability to translate strategy into action, • Excellent analytical skills with an ability to summarize and present complex information in a clear and concise manner to support decision-making, • Ability to create an inclusive environment and lead empowered teams who operate with high standards of alignment, trust, accountability, expertise, transparency, and collaboration, • Outstanding verbal and written communications skills with the ability to effectively interact with and influence all levels within the company, • Ability for minimal travel, • Dedicated team player who is able to withstand the high demands of a fast-paced environment Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $200,000 to $300,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. About the Role: Staff Accountant that will play a key role in supporting the month end close process, maintaining accurate financial records Minimum Qualifications: • Bachelor’s degree in Accounting, Finance, or a related field., • CPA or progress toward CPA is a plus, • 2–5 years of accounting experience, preferably in a publicly traded pharmaceutical, biotech, or life sciences industry., • Strong understanding of US GAAP and internal control principles., • Advanced Excel skills (VLOOKUP, pivot tables, formulas)., • Experience with inventory accounting and cost of goods sold (COGS) is a plus., • Excellent analytical, organizational, and communication skills., • Ability to work independently in a fast-paced, evolving environment. Responsibilities: • Prepare and post journal entries in NetSuite related to prepaids, revenue, expenses, accruals, and general ledger accounts., • Reconcile balance sheet accounts, including cash, inventory, prepaid expenses, and accrued liabilities., • Assist in monthly, quarterly, and year-end close processes in compliance with GAAP and internal deadlines., • Support the accounting and finance team with audits, including preparation of schedules and documentation., • Collaborate with cross-functional teams, including R&D, manufacturing, and supply chain, to ensure accurate financial tracking of pharmaceutical operations., • Maintain fixed asset schedules and perform depreciation calculations., • Monitor and record intercompany transactions and reconcile intercompany balances., • Assist with the preparation of financial statements and management reports., • Ensure compliance with internal controls and help identify opportunities for process improvement. Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $60,000 to $90,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview The Regulatory Affairs Specialist – CMC is responsible for supporting global regulatory submissions and lifecycle management activities related to the chemistry, manufacturing, and controls (CMC) components of drug development. This role ensures that all CMC documentation complies with applicable regulatory requirements and company standards, enabling timely approvals and continued product compliance. Essential Duties and Responsibilities • Prepares and/or coordinate activities for investigation and new product registrations, post approval changes, renewals, annual reports, and extension applications ensuring on-time and high-quality global submissions., • Interface with external Contract Manufacturing Organizations (CMO) and relevant functional teams in obtaining the necessary CMC documentation in support of a regulatory submission., • Execute preparation of timely responses to CMC regulatory questions in coordination with Subject Matter Experts (SME) as needed., • Reviews and assesses change control requests pertaining to CMC aspects and coordinates filing strategies with minimal assistance; attend change control meetings as regulatory-CMC representative., • Maintain submission information according to the document management system, track regulatory commitments & timelines for specific projects/products/markets with minimal supervision., • Maintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements., • Familiarity with global CMC regulations, including ICH requirements and US/EU regulatory guidances., • Experience in authoring technical documents, CTD M2 and M3 sections., • Experience with post-approval CMC changes and lifecycle management., • Strong oral and written communication skills with superior attention to detail., • Demonstrates initiative and is proactive; ability to work independently and within a team setting., • Minimum of a bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, Chemistry)., • 4 + years of experience in Regulatory Affairs specifically with Small Molecules focused on Regulatory CMC. Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $70,000 to $120,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

Job Description We are seeking an Import Customs Broker to support our growing import operations based in Rahway, NJ (on-site). This role manages end-to-end customs clearance, classification, and compliance for U.S. imports, while also leveraging Python skills to automate reports, improve data accuracy, and streamline brokerage workflows. Experience is not the key filter. We are open to candidates who are newly licensed (or recently passed the CBP exam) and ready to grow fast. If you’re sharp in Excel, know the basics of Python, and have an “automate everything” mentality, we want to talk to you Key Responsibilities Customs Brokerage & Import Ops • Prepare and process import documentation including customs entries, bills of lading, commercial invoices, packing lists, permits, and ISF where applicable. • Ensure accurate and timely submission of entries to U.S. Customs & Border Protection (CBP) and relevant Partner Government Agencies (FDA, USDA, EPA, etc.). • Classify goods using the Harmonized Tariff Schedule (HTS); validate duty rates, special programs, and admissibility requirements. • Strong Excel skills (formulas, pivots, lookups; comfortable with large datasets)., • Basic Python knowledge (comfortable with simple scripts, working with CSV/Excel data, and learning new functions/libraries). • High attention to detail, willingness to ask questions, and ability to learn quickly., • Clear communication and customer-service mindset., • Strong initiative and enthusiasm for improving/automating workflows., • Coordinate with clients, carriers, and government agencies to resolve holds, exams, or post-entry issues quickly. • Maintain current knowledge of customs regulations, trade updates, and brokerage best practices. • Support compliance audits, recordkeeping, post-summary corrections, and reporting. • Deliver standout customer service: provide shipment status, explain clearance steps, and advise on documentation requirements. Automation / Data Focus • Use strong Excel skills to track, audit, and report import activity., • Apply basic Python scripting to automate tasks such as: o entry validation checks o exception/KPI reports o shipment status dashboards o data cleanup and file merges • Continuously identify repetitive processes and help streamline them through automation., • Collaborate with operations/management to identify processes suitable for automation and build lightweight scripts/tools. • Strong excel skills – if you don’t know how to use Vlookup/Xlookup please do not apply. Qualifications Required • Bachelor’s degree., • 1+ years in customs brokerage and/or freight forwarding imports., • Strong working knowledge of CBP regulations, entry filing, ISF, PGA processes, and HTS classification. • Excellent attention to detail and accuracy., • Strong Excel skills, • Python competency (automation, data cleaning, reporting)., • Active U.S. Customs Broker License., • Experience with ABI/ACE systems and brokerage platforms., • Familiarity with auditing frameworks and post-entry compliance.

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director, Medical Affairs + Health Impact (MHI) is a key scientific expert within the Pipeline Psychiatry Therapeutic Area. The position supports the development and execution of the Pipeline Psychiatry medical strategy by leading execution of strategic, insight, and educational initiatives in psychiatry. The Director provides expert-level scientific, strategic and operational input into core MHI activities and cross-functional strategic teams including evidence, insight, thought leader engagement plans, and clinical trial site interactions; generation and dissemination of clinical and scientific data; provider and payer educational initiatives. This position can be based from our Mettawa, IL or Florham Park, NJ or Cambridge, MA location. Key Responsibilities • Collaborates with Pipeline Medical Strategy team to contribute to scientific strategy for pipeline psychiatry assets, including asset, education, and evidence strategies, • Develops and leads the execution of medical education tactics, advisory boards, and thought leader engagement plan in line with psychiatry pipeline strategic plan., • Leads conference planning and execution, • Oversee clinical trial site identification, engagement, and education initiatives, • Provides subject matter expertise for MSL, health outcomes and commercial teams including competitive assessments and regular scientific literature reviews., • Oversees development of early Scientific Communication Platforms and ensures alignment of all tactical initiatives, • Responsible for managing budget for assigned projects including consulting and vendor management.Qualifications, • Scientific degree (bachelor’s) required. MD, PhD, PharmD and/or other advanced scientific degree strongly preferred. Preferably 'board certified specialty qualification' or equivalent and pharmaceutical industry recognized qualification e.g. MSc, • 5-7+ years of prior biopharmaceutical/medical device industry experience, including substantial understanding of relevant therapeutic area required, • Should have a good understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals)., • Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations, • Good understanding of Medical Affairs principles, study design and publications., • Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred., • Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc., • Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc., • Ability to work effectively in a team/matrix environment Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionTerritory: Metro New Jersey/New York States Covered: Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut, New York, New Jersey, Pennsylvania, Delaware, Maryland, Virginia, West Virginia Department: Commercial Reports To: Vice President of Sales About AMDI Autonomous Medical Devices Incorporated (AMDI), headquartered in Santa Ana, California, brings together a world-class team of engineers, scientists, clinicians, and manufacturing experts dedicated to advancing point-of-care diagnostics. From its ISO 13485-certified, 110,000 sq ft facility, AMDI develops and manufactures innovative diagnostic systems leveraging breakthrough microfluidics, protein engineering, and cloud-connected data solutions. Our lead product, the Fast PCR System, delivers molecular respiratory results (Flu A, Flu B, RSV, and COVID-19) in under 10 minutes — purpose-built for urgent-care and office-lab settings. The pipeline includes future assays, designed for CLIA-waived environments, underscoring AMDI’s mission to deliver accurate results at the time of care. Role Summary The Territory Manager defines, develops, and executes the sales strategy within an assigned region and plays a critical role in AMDI’s transition from R&D to full-scale commercialization. The Territory Sales Manager is responsible for all aspects of sales execution, key account management, forecasting, customer engagement, and performance analytics. The role is accountable for instrument placements, adoption, market-share expansion, and customer satisfaction within the assigned geography. Essential Duties & Responsibilities Sales Strategy and Execution • Execute the commercial launch of AMDI’s Fast PCR System, consisting of the Fast PCR Base Station and one or more Fast PCR Operating Modules within territory., • Drive instrument placements across urgent-care and high-volume primary-care markets., • Develop strategies to identify, prioritize, and close large urgent-care and PCP network opportunities., • Manage a full sales cycle including contracting, installation, and post-install adoption., • Use Salesforce CRM to build and manage pipelines, forecast accurately, and drive data-driven decisions., • Partner with Marketing to execute lead-generation and conversion programs that support scalable territory growth., • Work with Sales Leadership to monitor, exceed, and accelerate placement targets., • Ensure timely completion of administrative tasks (CRM updates, expense reports, training modules).Customer Engagement and Account Ownership, • Build and sustain strong relationships with key decision makers across urgent-care chains, primary-care groups, and office labs., • Deliver compelling demos and workflow consultations that highlight speed, accuracy, and ROI., • Own the post-install adoption process for 90 days, coordinating training and utilization growth., • Ensure all communications reflect professionalism, integrity, and regulatory compliance.Cross-Functional Collaboration, • Partner cross-functional with Sales, Marketing, Product Management and Customer Service to optimize launch execution., • Provide timely market intelligence on customer likes and dislikes about the offering, competitor activity, and reimbursement trends., • Participate in regional and national trade shows; occasional weekend travel required.Operational Excellence, • Implement and maintain Salesforce CRM reporting for complete visibility into pipeline, forecast, and activity metrics., • Conduct regular funnel and performance reviews with Sales Leadership; present data-driven insights and recommendations for improvement., • Contribute suggestions for pricing, incentive structures, and commercial strategy adjustments in close collaboration with the executive team.Team Building and Leadership, • Model a culture of customer focus, accountability, and performance excellence., • Support peers through collaboration, knowledge sharing, and field best-practice exchange.Key Performance Indicators (KPIs), • Instrument Placements: Primary success metric; focus exclusively on the placement of Fast PCR Base Stations and Operating Modules., • Quarterly attainment of annual placement goal., • Commissions: Uncapped; incentives tied to Base Station and Operating Module placements., • Pipeline Health: Weekly CRM updates and forecast accuracy ≥ 95 %., • Activity Cadence: 20–30 qualified customer calls per week and 5–10 demos per week (targets may vary by territory). Qualifications • Minimum of high school diploma or equivalent. Bachelor’s degree preferred., • Minimum 3 years successful sales experience in medical devices, diagnostics, or molecular in vitro diagnostics., • Experience launching new products into the U.S. market strongly preferred., • Proven track record and deep, up-to-date knowledge about the urgent-care, primary-care, or CLIA-waived point-of-care markets., • Understanding of capital equipment sales models with recurring consumables (reagent-rental, subscription, service bundles)., • Familiarity with IDN/GPO structures and enterprise deal cycles., • Skilled in forecasting, territory planning, and account segmentation., • Strong presentation and communication skills for executive and clinical audiences., • Self-starter comfortable in a fast-moving environment., • Must possess valid driver’s license and clean MVR, • Ability to lift and transport a 30–40 lb demo unit., • Ability to travel 50–60% of the time (with overnights, weekends, and occasional holidays)., • Possessing relationships with key decision-maker contacts within large Urgent Care /Health System networks within respective territory is a plus., • Ability to read, analyze and interpret common scientific, technical journals, and legal documents, • Other responsibilities or projects assigned as the need arise. Work Environment • Field-based / remote within assigned territory., • Combination of remote work arrangement and customer site visits., • Travel to corporate HQ for training and company events, as needed., • Domestic travel required; occasional weekend conference support. Compensation & Benefits • Base Salary: $100K-$150K, • Commission: Uncapped, performance-based variable compensation with On-Target Earnings (base + commission) in the ~$180K–$230K range, depending on experience and performance., • Benefits Include:, • Eligible for Incentive Stock options, • Monthly vehicle stipend (sales territory role only), • 13 company-paid holidays plus generous vacation and sick days, • Daily on-site free lunch, snacks, and drinks (when at corporate HQ), • 100 % employer-paid medical insurance for employee coverage (base plan), • 401(k) with company match, • Education assistance program, • Monthly socials and employee events, • Employee discounts on theme parks, movie theaters, hotels, and rental cars Why Join AMDI At AMDI, you’ll join a mission-driven organization pioneering the future of molecular testing at the point of care. The Fast PCR System delivers true PCR accuracy in under 10 minutes — empowering providers to make faster, improved clinical decisions. You’ll work with an experienced leadership team that has launched and scaled global diagnostics platforms. This is a rare opportunity to be part of a growth-stage company that values speed, integrity, and positive clinical impact. Compliance and Quality Operate in full compliance with AMDI’s Quality Management System and applicable CLIA, FDA, HIPAA, and anti-kickback regulations. Maintain ethical standards in all business conduct. vfTI2qG5xW

Job Description About Lantheus Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands. This role will be based at Evergreen Theragnostic, a Lantheus company, located in New Jersey, requires a presence on-site four days per week, and is and open to applicants authorized to work for any employer within the United States. Responsibilities The Associate Director, Technology Development and Transfer, acts as a technology development and transfer lead in the Tech Ops organization. This position will lead and manage the Manufacturing Science and Technology (MSAT) team at Evergreen. This role will be accountable for the technical work between internal and external stakeholders to ensure design, development, and transfer of robust manufacturing processes for new products and key lifecycle injectable pharmaceutical finished products. This role will be the principal expert and process owner for the end-to-end manufacturing process for injectable pharmaceutical finished products. Ensures processes are designed and validated per applicable cGMPs, Evergreen Theragnostics’ procedures, and that processes are defined consistent with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be responsible for review and authoring of key CMC submissions, along with setting relevant standards and creating /maintaining associated tech development transfer business processes. Additionally, this role: • Leads technology development and transfer projects for key lifecycle injectable radiopharmaceutical products, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities., • Leads a team of engineers/scientists to execute the development, characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms., • Leads a team of engineers/scientists to Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies (PCS)., • Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental or authoring plans or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes with internal and external stakeholders., • Partners with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage., • Partners with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for business growth., • Partners with site operations to provide a parenteral manufacturing process that is sustainable for future product supply. Partners with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized manufacturing process., • Leads, motivates, mentors, and develops team members to exceed and meet company goals., • Develops and maintains effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities., • Leads a team of engineers/scientists to own QEs (i.e. Change controls, Investigations, CAPAs, Protocol & report writing), • Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders., • Requires approximately ~20% travel., • Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment., • Reports and takes initiative to correct safety and environmental hazards., • Requirements include a B.S. or M.S. in relevant scientific/technical disciplines, advanced degrees (e.g., PhD) or technological certificates preferred but not required., • 5+ years of experience in the radiopharmaceutical industry, including 3+ years focused on technology development and tech transfer activities., • If no prior radiopharmaceutical experience, 10+ years of work experience within pharmaceutical or medical device industry, 5+ years of technology development and transfer experience, within a matrixed pharmaceutical, medical device, or biotechnology organization., • Subject matter expert (SME) in parenteral operations: aseptic processing, sterilization, sterile filtration, isolator technology operations. Strong knowledge of global regulatory requirements related to the design and control of these processes., • Knowledge of SOPs, cGMPs and GLPs and the ability to work and manage within a regulatory environment., • Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product manufacturing processes., • Ability to work within and lead different technical teams., • Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing., • Excellent organizational skills and the ability to successfully manage a multitude of technical projects., • Ability to work in a prompt, complex and changing environment., • Excellent analytical, technical and experiences., • Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills., • Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired., • Experience working with external partners is highly desirable., • Ability to work independently in decision-making and resolution of program obstacles and conflicts., • Keen insight, independent judgment and tactful discretion are required., • Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”., • Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Evergreen Theragnostics’ to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism. The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone’s health is in our hands Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until January 10, 2025. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at .

Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. About the Role The Manager, Government Affairs plays a critical role in shaping and advancing the organization's public policy objectives by engaging with government officials, regulatory agencies, and key stakeholders. This position is responsible for monitoring legislative and regulatory developments, analyzing their potential impact, and developing strategic responses to influence policy outcomes favorably. The role requires building and maintaining strong relationships with policymakers and industry groups to advocate effectively on behalf of the organization. The Manager will lead efforts to communicate the organization's positions clearly and persuasively, ensuring alignment with overall business goals. Ultimately, this role drives the organization's ability to navigate complex political environments and secure a competitive advantage through proactive government engagement. Essential Duties • Monitor and analyze federal, state, and local legislative and regulatory activities relevant to the organization's interests., • Develop and implement government affairs strategies that support the organization's business objectives and compliance requirements., • Build and maintain relationships with elected officials, government agencies, industry associations, and other stakeholders., • Prepare briefing materials, position papers, and testimony to effectively communicate the organization's policy positions., • Coordinate with internal teams to align government affairs initiatives with corporate strategy and operational priorities., • Represent the organization at public hearings, industry forums, and coalition meetings to advocate for favorable policy outcomes., • Proficiency with Quality system applications (e.g., eDMS, QMS), • Dedicated team player who is able to withstand the high demands of a fast-paced environment., • Results driven, problem solver, and collaborator Excellent written and verbal communication skills, • Excellent planning and time management skills and the ability to handle several tasks simultaneously., • Comfortable working independently with minimal supervision, • Ability for travel up to 20% of the time, • Must be able to provide clear direction while motivating teams., • At least 5 years of experience in government affairs, public policy, or legislative advocacy., • Master’s degree in Public Administration, Public Policy, Law, or related discipline., • Experience working within or closely with the private sector in a regulated industry., • Familiarity with lobbying compliance and ethics regulations., • Established network of contacts within government agencies and legislative bodies. Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $100,000 to $150,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

Job Description Entry Writer – New Jersey ???? Salary: $50,000 – $75,000 (commensurate with experience) ???? On-site | Full-time | Substantial Global Freight Forwarder About the Opportunity: A well-established international freight forwarder is seeking an experienced Entry Writer to join its growing Customs Brokerage team in New Jersey. This is an excellent opportunity to build a long-term career with a stable, reputable company that values compliance, teamwork, and professional development. Requirements Key Responsibilities: • Prepare, review, and file customs entries for import shipments in compliance with U.S. Customs and Partner Government Agencies (PGA) regulations., • Classify merchandise using HTS codes; verify valuation, country of origin, and duty calculations., • Communicate with importers, carriers, and agencies to resolve holds, exams, or documentation issues., • Maintain complete and compliant entry documentation and audit records., • 1–3+ years of customs entry writing or import operations experience within a freight forwarding or customs brokerage environment., • Working knowledge of CBP regulations, HTS classification, and PGA filings (FDA, USDA, EPA, etc.)., • Experience using systems such as CargoWise, AS400, or similar., • Excellent attention to detail, accuracy, and written/verbal communication. Standard Benefits: • Medical, Dental, and Vision Insurance, • 401(k) Retirement Plan with Company Match, • Paid Time Off (Vacation, Sick, and Holidays), • Life and Disability Insurance, • Work for a substantial, well-established freight forwarder with strong industry presence., • Supportive and collaborative work culture focused on long-term growth., • Competitive compensation and benefits aligned with industry standards.

Job Description About Lantheus Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands. This role will be based at Evergreen Theragnostic, a Lantheus company, located in New Jersey. Summary of role We are seeking an Associate Director, Quality Control. The Associate Director, QC, acts as senior leadership for the Quality Control operation at Lantheus’ Evergreen site. This position will oversee and lead the QC department at Evergreen. This role will be accountable for governing the department in terms of function and responsibility as well as providing technical guidance/decisions (when needed) for the operational levels to ensure an efficient and structured operation that can cater to internal as well as external needs within the organization to deliver quality radiopharmaceutical products. This role will be the primary accountable person for the success of the QC department operations at Evergreen Theragnostics in terms of efficiency, skill retention and compliance. Ensures processes are designed and compliant per applicable cGMPs, procedures, and that processes are defined consistent with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be accountable for the review and authoring of key CMC submissions, along with setting relevant standards for analytical operations. This position is based in New Jersey and requires a presence on-site, three days per week, and open to applicants authorized to work for any employer within the United States. Responsibilities • Design, establish and maintain a standard QC operational structure with assigned roles and responsibilities that can be aligned with the needs of the organization., • Oversee the creation and maintenance of a QC training matrix and program to ensure consistency in execution and retention of capability & skill., • Define specific qualification standards for SMEs and the subsequent qualification processes., • Manage mid-management (supervisors, managers etc) direction to ensure alignment of objectives and completion of deliverables by the department., • Provide technical guidance and decisions to mid-management in order to be able to achieve the required objectives and deliverables., • Design, maintain and defend the internal departmental processes to ensure compliance to cGXP requirements., • Oversee and manage departmental efficiency and proficiency to enable a lean operation., • Review and approve department related protocols, procedures, test methods, and studies as appropriate. Responsible to create, maintain and harmonize key business processes with internal and external stakeholders., • Partner with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage., • Partner with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Lantheus’ business growth., • Partner with site operations to effectively deliver analytical services to meet product release timelines for future product supply. Partner with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized analytical process., • Leads, motivate, mentor, and develops team members to exceed and meet company goals., • Develop and maintain effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities., • Lead assigned operational personnel in owning Quality processes within the required responsibility of the department (i.e. Change controls, Investigations, CAPAs, Protocol & report writing), • Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders., • Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment., • Report and take initiative to correct safety and environmental hazards., • Actively demonstrate Lantheus’ values Basic Qualifications • Requirements include a B.S. in relevant scientific/technical disciplines, advanced degrees (e.g., MS) or technological certificates preferred but not required., • 2+ years of experience in the radiopharmaceutical industry preferred but not required, • Minimum 10+ years experience in a GMP Quality Control Environment., • Minimum 5+ years experience in people management and conflict resolution., • Minimum 3+ years experience in defending QC operations against FDA and EMEA regulatory inspections., • Previous experience with managing a microbiology department is preferred., • Subject matter expert (SME) in various analytical test methods and analytical technology. Strong knowledge of global regulatory requirements related to the design and control of these processes., • Knowledge of SOPs, cGMPs, GCPs and GLPs and the ability to work and manage within a regulatory environment., • Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product analytical processes., • Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing & testing., • Excellent organizational skills and the ability to successfully manage a multitude of technical projects., • Ability to work in a fast paced, complex and changing environment., • Excellent analytical, technical and experiences., • Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills., • Understanding of FDA and/or EMEA quality and regulatory processes. Prior experience with regulatory filings is highly desired., • Experience working with external partners is highly desirable., • Ability to work independently in decision-making and resolution of program obstacles and conflicts., • Keen insight, independent judgment and tactful discretion are required., • Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”., • Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Lantheus and the Evergreen site to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism. The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone’s health is in our hands Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until January 12, 2026. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at .

The (Senior/Executive) Medical Director (MD) - will provide strategic leadership to develop Clinical Development Plan (CDP), working closely with partners in Pre-Clinical, Regulatory, Safety, Stats, & Project Management. Core responsibilities will encompass developing & implementing the Clinical Development Plan and providing leadership to new product development from IND to submission. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within timelines & with high quality. Candidate must possess passion for science and patients, as well as entrepreneurial drive along with strong hands-on experience to help the organization succeed. MAJOR RESPONSIBILITIES AND DUTIES • Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program, • Design Comprehensive Development Plans (CDPs), clinical trials and protocols and execute in accordance with applicable Good Clinical Practice (GCP) regulations., • Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.), • Define project timelines & deliverable, working closely with cross functional team and assure that deliverable is completed on time, on budget and according to the highest quality, ethical and professional standards., • Identify project risks with input from the cross functional teams, and support resolving issues., • Provide therapeutic area medical and scientific expertise to study teams and key stakeholders., • Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and factors into planning., • Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision., • Lead & author relevant sections of INDs, Investigator Brochures, Protocols, CTAs, BLA, ISS, ISEs and clinical expert reports with high quality., • Interact with Regulatory authorities (FDA, EMA etc.) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums., • Performs all duties in keeping with the company’s core values, policies and all applicable regulations., • Ensure data review quality (e.g. patient eligibility, Protocol Deviation review, efficacy and safety review) and data accuracy., • Conduct safety review and safety follow up., • Interpret data and ensure CSR quality/Briefing book quality., • Interact with the HA and IRB/EC and Answers to medical questions raised by EC/IRBs and sites; identify the need of protocol amendment and maintain appropriate compliance with protocols., • Interact with the participant Principle Investigators on protocols., • Conduct literature research and competitive intelligence tracking for assigned projects. QUALIFICATIONS • MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area;, • 5 or more years of pharmaceutical experience in Clinical Development for (Senior) Medical Director., • Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required., • Knowledge of Oncology is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports, • Knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes, • Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies., • Experience in biotech is preferred., • Willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment., • Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement., • Ability to be flexible and adapt quickly to the changing needs of the organization., • Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams., • Highly collaborative & effective influencing skills and the ability to operate across multiple geographies.

Title: Manufacturing Associate Location: Summit West, NJ, 07901 Duration: 6 Months Assignment with potential to extend Training: 4–6 weeks | Onsite | Monday–Friday | 9 AM – 5 PM Shift: Thursday – Saturday, alternating Wednesdays | 12 hour rotational shift Quick Summary: Ideal for candidates with hands-on experience in biotech or pharmaceutical manufacturing, particularly in aseptic or cleanroom settings. Recent graduates with laboratory or manufacturing experience are also encouraged to apply. Join a cutting-edge cell therapy manufacturing team at the forefront of innovation! We’re looking for Manufacturing Associates to support production of blood-derived cell therapies in a controlled cGMP cleanroom setting. Key Responsibilities: ✔️ Execute cell culture, harvest, and cryopreservation procedures ✔️ Operate under strict aseptic techniques and cleanroom protocols ✔️ Follow SOPs and GDPs for documentation and compliance ✔️ Collaborate in a team-based environment, reporting deviations and supporting quality investigations Who We're Looking For: • Understanding of biology, chemistry, or clinical practices, • Familiarity with cGMP/FDA regulations, • Comfortable in a cleanroom for extended periods (up to 6 hrs), • Bachelor’s, Associate/Medical Technical degree with 2+ years of experience, or HS diploma/GED with 3+ years in manufacturing Important Notes: No makeup, nail polish, or electronic devices in restricted areas Expect exposure to human blood components and sanitization agents

PRIMARY FUNCTION • Director/Senior Director plays a key role as clinical technical lead on global Phase I-III and other clinical pharmacology centric projects, • Serves as a team member supporting multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. This position is also the scientific and medical/clinical liaison between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, medical monitors, regulatory authorities, medical affairs, commercial, Key Opinion Leaders, Advisory Boards, • The candidate will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK/PD, drug metabolism, drug-drug interactions, PBPK, PopPK modeling and E-R analysis. Provides peer-reviewed interpretation of clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions MAJOR RESPONSIBILITIES AND DUTIES • Accountable and responsible for the Clinical Pharmacology support for the HUTCHMED global portfolio, • Provide scientific insights that drive global clinical development decisions and support global regulatory submissions, • Responsible for ensuring appropriate Clinical Pharmacology representation on drug/ dosage form development and clinical teams and provision of PK/PD expertise and leadership to a project, • The incumbent will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed, • Responsible for ensuring planning and direction of Clinical Pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including synopsis and protocol preparation; clinical phase oversight, reporting), • Responsible for ensuring leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensuring overall scientific accountability for the designated studies, • Responsible (with members of Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses in first in human studies and dosage regimens in patients, • Responsible for summarizing and interpreting results of pharmacokinetic, pharmacodynamic analyses with respect to their impact on development and clinical use of drugs, • During the pre-clinical stages of drug development, works with Drug Discovery team to ensure that sufficient preclinical PK/PD knowledge exists to support progression into first in man studies, • Accountable for ensuring that there are valid methods for measuring drug and metabolite concentrations (or any biochemical biomarkers) in human studies, • Coordinates with medical writers (and other team members) in the data review, analysis and reporting of the Clinical Pharmacology study, • Responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off. Assist with internal and external dissemination of results to Development Team, Investigators etc., • Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the Clinical and Development teams and in regulatory documentation such as labeling, • Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology and therapeutics knowledge in terms of both medical background and clinical trial design, • Participates in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management, • Acts as technical lead for specific development projects, Phase I/III and Clinical Pharmacology centric studies, • Manage and initiate external collaborations with leaders in clinical pharmacology and Key Opinion Leaders MINIMUM REQUIREMENTS • PhD in clinical pharmacology, quantitative pharmacology, pharmacokinetics, or related field / MD/ PharmD preferred, • Biologics including monoclonal antibody, bispecific antibody, and antibody-drug conjugate experience is preferred, • Experiences in Oncology/Autoimmune disease field is preferred, • Proven expertise in pharmaceutical/biotech industry (8-15 years) with adequate knowledge in ICH guidelines, Good Clinical Practice applicable to Clinical Pharmacology, • Direct experience with clinical pharmacology summary documents required for Regulatory submissions, • Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization, • Experience in clinical development and new drug registration, • Mastery of statistics applied to clinical research, • Ability to work with pharmacometrician for PopPK modeling, E-R analysis, PBPK, and PK-PD modeling, and interpret the data to support the clinical development, • Good ability to interpret complex clinical data and experimental results, • Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy, • Self-motivated and self-disciplined individual with superb problem-solving and leadership skills, • Excellent English (writing and speaking) and excellent mastery of English medical terminology PREFERRED SKILLS AND EXPERIENCE: • Knowledge of FDA, EMA and ICH guidelines and regulations, • Record of successful publications in the area of clinical pharmacology/pharmacometrics, • Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization. Prior direct interaction with regulatory agencies and advisory boards is required, • Candidate must demonstrate thorough understanding of principles of clinical pharmacology including clinical study design, analysis, and interpretation, and application of these approaches to drug development, guidelines in the design of clinical trials and development plans KEY COMPETENCIES: • Ability to organize and work simultaneously on multiple projects, • Ability to work in a matrix, project-oriented environment, • Excellent written and oral communication skills, interpersonal/influencing skills, and ability to work in a continually changing environment, • Supports the success of a group being led by providing clarity, support and tools needed to excel as things change, • Maintains a functional, perspective and acts on the belief that solutions and plans are stronger when appropriate collaboration occurs across and beyond the organization, • Actively builds relationships and networks with others across and beyond HUTCHMED working constructively across organizational boundaries despite differences in interests, perspectives and need

Our client is looking for a high-energy Project Manager for their Madison, NJ sales office. Experience in cosmetic packaging is required (ie. pumps, sprays, bottles and various other cosmetic packaging). As the Project Manager, you will keep the business moving with oversight and behind-the-scenes support, tracking schedules/tasks, building customer quotes, supporting new project timelines, and organizing manufacturing - with uncompromising attention to detail. This role collaborates daily with Packaging Managers, Program Managers, Client Management Specialists, Quality and existing vendors. Key Responsibilities • Project Info Liaison: Go-to source for status, risks, updates; push proactive communication; maintain real-time records., • Reporting: Deliver weekly updates, risks, milestones to leadership., • Partner with Packaging Managers on timing, samples, production timelines, and or Program Manager alignment., • Collaborate with Client Management Specialists and Sales Team on order tracking, customer needs, deliverables/specs, and client communication., • Customer Quotes: Build accurate, competitive quotes using existing cost data; include assumptions, lead times, MOQs; present professional packages; revise quickly., • New Project Timelines: Lead timeline creation—map critical path (design freeze, mold fab, range boards and color matching, printing, sampling, QA, trials); use established vendor data., • Sample Management: Coordinate receipt, inspect with Engineering for defects, functionality, color accuracy, and spec adherence; document, repackage, ship client-ready samples; escalate issues., • Schedule & Tasks: Maintain master schedules (MS Project/ERP) including current purchase orders of repeat items; assign/track tasks (mold approval, range boards and color matching, printing setup, QA, shipping); send reminders; escalate blockers., • Customer Requests: Capture, route, verify completion with uncompromising attention to detail., • Partner with Sales Team: Organize cost/timeline-accurate quotes + samples to win business., • Development Process Participation: Be part of the development process on customer calls to support needs/requests and keep projects on pace., • Project Oversight: Keep projects moving with oversight and behind-the-scenes support—lead full-cycle launches: custom molded components, range boards, color matching, and customer approvals. Qualifications: • Bachelor’s degree in Engineering (Packaging, Mechanical, Chemical, or Industrial) preferred., • 4+ years in cosmetics/personal care packaging project management., • Track record with CMs and brands: L’Oréal, Estée Lauder, Avon, Coty, Revlon, P&G, Unilever, Puig., • Success as info liaison, quoting (existing data), timeline creation, sample/engineering/QA/schedule management., • Hands-on with injection/blow/glass molding, range boards, color matching, and printing., • Supported sales via cost/timeline execution., • Worked with technical/client teams., • Highly skilled in MS Project, ERP, Jira, timeline development., • Familiar with molding processes, printing, FDA/EU, quality systems (CAPA/NCR), cost analysis (no sourcing)., • Uncompromising attention to detail in sample/quote handling, execution, and documentation., • Exceptional communication, follow-through, accountability. Submit your resume today!

About Wakefern Wakefern Food Corp. is the largest retailer-owned cooperative in the United States and supports its co-operative members' retail operations, trading under the ShopRite®, Price Rite®, The Fresh Grocer®, Dearborn Markets®, Fairway Markets, Gourmet Garage®, Di Bruno Bros®, and Morton Williams® banners. Employing an innovative approach to wholesale business services, Wakefern focuses on helping the independent retailer compete in a big business world. Providing the tools entrepreneurs need to stay a step ahead of the competition, Wakefern’s co-operative members benefit from the company’s extensive portfolio of services, including innovative technology, private label development, and best in class procurement practices. Your contribution The Product Inspector position is responsible for performing routine and thorough inspections of all inbound perishable foods to ensure the quality, wholesomeness, proper labeling, and fair packaging in adherence to the Wakefern standards. The Product Inspector will be expected to exhibit first-hand knowledge of Wakefern’s Food Safety and Quality Practices along with USDA and FDA Guidelines. Additional job functions noted below. The hours worked will be 12:00am-8:00am. What you will do • Inspects all inbound deliveries to ensure the purchased goods conform to all established product specifications, standards, and grade requirements. This applies the Drive for Results competency., • Performs random organoleptic inspections of inbound goods to assure the quality, grade, and wholesomeness of the product., • Inspects all inbound deliveries for cleanliness and soundness of the transportation vehicle and the absence of cross contamination., • Monitors product temperatures by means of physical probing of goods and observation of time and temperature recording devices., • Verifies the weights and counts of received goods., • Examines all packaging for proper labeling and enforces all packaging and labeling requirements of the FDA, USDA, and USDC., • Monitors products in inventory and storage for quality and safety., • Performs daily sanitation inspections of all applicable facilities and warehouses., • Gathers and organizes all records and documentation to comply with all regulatory requirements., • Monitors all control points, critical control points, and quality control points for each of the food safety and food quality plans for the applicable perishable food facilities., • Monitors store returns to determine if credit is warranted and direct operations as to the disposition of the returned goods. Core Competencies • Communicate Effectively: Communicates thoughts and ideas in a well-organized manner, encouraging two way communication., • Build Relationships: Creates cross functional partnerships through the development and maintenance of constructive and cooperative relationships., • Stay Competitive: Demonstrates a mindset of continuous improvement while exhibiting passion and enthusiasm for their work., • Embrace Change: Looks for new ways of working by supporting advancements in processes and technology., • Develop You: Identifies and capitalizes on opportunities for personal and professional career growth., • Drive for Results: Supports divisional and strategic objectives through achievement of work goals. What we're looking for • Four year College degree preferred, or presently enrolled with a minimum of 60 credits, or a minimum of 3 years equivalent work related experience., • Knowledge of USDA, AMS Grade Standards and inspection procedures, impacting the Drive for Results competency., • Knowledge and understanding of FDA Preventive Controls for Human Food requirements, applying the Stay Competitive competency., • Understanding and ability to monitor Sanitation Standard Operating Procedures., • Must be able to maintain accurate records and reports., • Ability to interact well with Supervision as well as Affiliated Warehouse Associates, applying the Build Relationships competency., • Ability to communicate effectively with all levels of management and vendor representatives., • Well-developed written and oral communication skills., • Skilled in WMS, Rapid, Outlook, Microsoft Word, and Excel., • Flexibility with regards to work schedule including days of the week, shifts, holidays, and locations. (Hours/Shifts 12:00am-8:00am). How you'll work • Ability to perform heavy lifting (up to 70 lbs.)., • Ability to walk the length of the warehouse multiple times throughout the day (back and forth from the docks)., • Physical demands include the ability to bend, stretch, extend, tug and pull based on inspection of various products, • Ability to work in cold temperatures as low as 33 degrees. Company Perks • Vibrant Food Centric Culture, • Comprehensive medical, dental and vision package, • Competitive Salary and Paid Time Off, • Fitness Reimbursement and Well-Being Program, • Corporate Training and Development University, • Collaborative team environment, • Paid Parental Leave, • 401K, • Matching Gifts and Community Volunteer Involvement Compensation and Benefits The salary for this position is $61,984.00. Placement in the salary depends on several factors, including experience, skills, education, geography, and budget considerations. Wakefern is proud to offer a comprehensive benefits package designed to support the health, well-being, and professional development of our Associates. Benefits include medical, dental, and vision coverage, life and disability insurance, a 401(k) retirement plan with company match & annual company contribution, paid time off, holidays, and parental leave. Associates also enjoy access to wellness and family support programs, fitness reimbursement, educational and training opportunities through our corporate university, and a collaborative, team-oriented work environment. Many of these benefits are fully or partially funded by the company, with some subject to eligibility requirements. More information can be found on our Count Me In website.

Program Dates May 19th, 2026 – August 7th, 2026 About Wakefern Wakefern Food Corp. is the largest retailer-owned cooperative in the United States and supports its co-operative members' retail operations, trading under the ShopRite®, Price Rite®, The Fresh Grocer®, Dearborn Markets®, Fairway Markets®, Gourmet Garage®, and Morton Williams® banners. Employing an innovative approach to wholesale business services, Wakefern focuses on helping the independent retailer compete in a big business world. Providing the tools entrepreneurs need to stay a step ahead of the competition, Wakefern’s co-operative members benefit from the company’s extensive portfolio of services, including innovative technology, private label development, and best in class procurement practices. Your contribution If you are a student who is pursuing an education in Supply Chain Management, Food Engineering, Quality Assurance, Quality Control Management, or other related fields, these internship opportunities may be a great fit for you! Wakefern prides itself in being the industry leader in Logistics and Distribution. Our organization currently services over 400+ retail stores throughout the northeast. The Logistics Infrastructure includes 9 warehouses in New Jersey and Pennsylvania, housing 4 million square feet of warehouse space. Wakefern’s fleet of over 2000 trailers ship approximately 1.4 million cases daily while traveling 52,000,000 miles per year! This sophisticated operation utilizes state of the art technology to meet the needs of our more than 8 million customers. Quality Assurance Product Inspector (Produce) track: This internship goes beyond a typical desk job, you’ll be immersed in the core of our supply chain operations. The QA (Produce) Intern plays a hands-on role in inspecting fresh produce and other perishable items to ensure quality, safety, and compliance with Wakefern standards. This position involves physically examining inbound deliveries for grade, freshness, proper labeling, and packaging integrity, as well as monitoring temperatures and verifying weights and counts. Interns will gain first-hand experience with Wakefern’s Food Safety and Quality Practices, USDA and FDA guidelines. Interns will be learning leadership skills mentored by supervisors to understand all skills required in a Quality Assurance Product Inspection department. What you will do • Work in a refrigerated warehouse environment., • Inspects all inbound deliveries to ensure the purchased goods conform to all established product specifications, standards, and grade requirements., • Performs random organoleptic inspections of inbound goods to assure the quality, grade, and wholesomeness of the product., • Inspects all inbound deliveries for cleanliness and soundness of the transportation vehicle and the absence of cross contamination., • Monitors product temperatures by means of physical probing of goods and observation of time and temperature recording devices., • Verifies the weights and counts of received goods., • Examines all packaging for proper labeling and enforces all packaging and labeling requirements of the FDA, USDA, and USDC., • Monitors products in inventory and storage for quality and safety., • Performs daily sanitation inspections of all applicable facilities and warehouses., • Gathers and organizes all records and documentation to comply with all regulatory requirements., • Monitors all control points, critical control points, and quality control points for each of the food safety and food quality plans for the applicable perishable food facilities., • Physical demands include the ability to bend, stretch, extend, tug and pull based on inspection of various products, Ability to work in cold temperatures as low as 33 °F., • 5 days on site - no remote work., • Wear OSHA-Compliant Steel Toe or Composite Safety Boots when in the warehouse is required., • Bilingual Spanish / English is a plus, but not required., • Provide coverage for the Shift Supervisors, working any 5 of the 7-days, including weekends, holidays, vacations, and peak volume periods. Interns work 40 hours per week., • Various projects as assigned., • Interns will be based out of one of the following warehouse locations and may work one of the following shifts: Locations/Shifts Northern Perishables – Elizabeth, NJ 5:00am-1:30pm or 6:00am-2:30pm (shift times may be later on certain days to reflect events interns are required to attend) Produce Facility – Newark, NJ 5:00am-1:30pm or 6:00am-2:30pm (shift times may be later on certain days to reflect events interns are required to attend) What we are looking for • Must be at least 18 years old, • Must have completed 24 college credits with a 3.0 cumulative GPA or better, • Will be enrolled in an undergraduate or graduate school for fall, • Successful completion of a substance abuse test is required, • Successful completion of a background check is required, • Reliable transportation is required, • Strong interpersonal, analytical, and customer service skills with the ability to multitask and manage time effectively, • Excellent communication skills (written, oral, and presentation), • Strong MS Office skills (Excel, Word, and PowerPoint required), • Ability to exhibit proper business etiquette when dealing with all levels of the organization, • Previous work experience in a retail environment is beneficial, • Must have flexibility with regard to schedule which can include coverage for a 7-day work week, weekends, holidays, vacations and peak volume weeks (interns will work 40 hours per week) Company Perks • Vibrant Food Centric Culture, • Corporate Training and Development University, • Collaborative Team Environment, • Educational Workshops, • Networking Opportunities, • Volunteer Opportunities Compensation and Benefits: First year Wakefern Supply Chain/Logistic Interns will be paid at $18.00 per hour. Master Students and Returning Wakefern Supply Chain/Logistic Interns will be paid at $19.00 per hour. Interns are not eligible for company benefits including medical, dental, and vision coverage, life and disability insurance, a 401(k) retirement plan with company match & annual company contribution, paid time off and holidays.

Year Long Contract 2 Hire *** Regulatory Site Quality Specialist JOB DESCRIPTION A large CPG client of ours is looking for a regulatory site quality specialist to help with their products OTC drug listing portfolio. This role is responsible for managing the drug listing process, including the listing and delisting of products (skincare, cosmetics). The position supports regulatory tasks and regulatory operations as needed, while collaborating with cross-functional teams on the initiation, review, and approval of change requests, deviations, and CAPAs. Key responsibilities include reviewing and approving incoming raw material documentation, LIMS specifications, and Certificates of Analysis, as well as GMP batch records, packaging protocols, clinical labeling records, and analytical laboratory documentation such as test methods, protocols, and reports. The role also involves participating in internal audits as a scribe and document reviewer, providing GMP consultation to project teams and departments, and serving as a backup for the QA Manager. REQUIRED SKILLS AND EXPERIENCE -BS degree in science or engineering -5 years' experience in Regulatory, Quality, R&D or Analytical in a GMP facility -Experience and understanding of FDA OTC Drug Listing Process -Experience and understanding GMP Procedures -Experience with SOPs, deviations, change controls, CAPAs -Detail Oriented, Organized -OTC Drug or Cosmetics Experience NICE TO HAVE SKILLS AND EXPERIENCE -LIMS experience -Cosmetics or skincare experience

PRIMARY FUNCTION • Associate Director/Director plays a key role as clinical technical lead on global Phase I-III and other clinical pharmacology centric projects, • Serves as a team member supporting multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. This position is also the scientific and medical/clinical liaison between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, medical monitors, regulatory authorities, medical affairs, commercial, Key Opinion Leaders, Advisory Boards, • The candidate will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK/PD, drug metabolism, drug-drug interactions, PBPK, PopPK modeling and E-R analysis. Provides peer-reviewed interpretation of clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions MAJOR RESPONSIBILITIES AND DUTIES • Accountable and responsible for the Clinical Pharmacology support for the HUTCHMED global portfolio, • Provide scientific insights that drive global clinical development decisions and support global regulatory submissions, • Responsible for ensuring appropriate Clinical Pharmacology representation on drug/ dosage form development and clinical teams and provision of PK/PD expertise and leadership to a project, • The incumbent will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed, • Responsible for ensuring planning and direction of Clinical Pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including synopsis and protocol preparation; clinical phase oversight, reporting), • Responsible for ensuring leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensuring overall scientific accountability for the designated studies, • Responsible (with members of Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses in first in human studies and dosage regimens in patients, • Responsible for summarizing and interpreting results of pharmacokinetic, pharmacodynamic analyses with respect to their impact on development and clinical use of drugs, • During the pre-clinical stages of drug development, works with Drug Discovery team to ensure that sufficient preclinical PK/PD knowledge exists to support progression into first in man studies, • Accountable for ensuring that there are valid methods for measuring drug and metabolite concentrations (or any biochemical biomarkers) in human studies, • Coordinates with medical writers (and other team members) in the data review, analysis and reporting of the Clinical Pharmacology study, • Responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off. Assist with internal and external dissemination of results to Development Team, Investigators etc., • Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the Clinical and Development teams and in regulatory documentation such as labeling, • Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology and therapeutics knowledge in terms of both medical background and clinical trial design, • Participates in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management, • Acts as technical lead for specific development projects, Phase I/III and Clinical Pharmacology centric studies, • Manage and initiate external collaborations with leaders in clinical pharmacology and Key Opinion Leaders MINIMUM REQUIREMENTS • PhD in clinical pharmacology, quantitative pharmacology, pharmacokinetics, or related field / MD/ PharmD preferred, • Biologics including monoclonal antibody, bispecific antibody, and antibody-drug conjugate experience is preferred, • Experiences in Oncology/Autoimmune disease field is preferred, • Proven expertise in pharmaceutical/biotech industry (8-15 years) with adequate knowledge in ICH guidelines, Good Clinical Practice applicable to Clinical Pharmacology, • Direct experience with clinical pharmacology summary documents required for Regulatory submissions, • Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization, • Experience in clinical development and new drug registration, • Mastery of statistics applied to clinical research, • Ability to work with pharmacometrician for PopPK modeling, E-R analysis, PBPK, and PK-PD modeling, and interpret the data to support the clinical development, • Good ability to interpret complex clinical data and experimental results, • Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy, • Self-motivated and self-disciplined individual with superb problem-solving and leadership skills, • Excellent English (writing and speaking) and excellent mastery of English medical terminology PREFERRED SKILLS AND EXPERIENCE: • Knowledge of FDA, EMA and ICH guidelines and regulations, • Record of successful publications in the area of clinical pharmacology/pharmacometrics, • Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization. Prior direct interaction with regulatory agencies and advisory boards is required, • Candidate must demonstrate thorough understanding of principles of clinical pharmacology including clinical study design, analysis, and interpretation, and application of these approaches to drug development, guidelines in the design of clinical trials and development plans KEY COMPETENCIES: • Ability to organize and work simultaneously on multiple projects, • Ability to work in a matrix, project-oriented environment, • Excellent written and oral communication skills, interpersonal/influencing skills, and ability to work in a continually changing environment, • Supports the success of a group being led by providing clarity, support and tools needed to excel as things change, • Maintains a functional, perspective and acts on the belief that solutions and plans are stronger when appropriate collaboration occurs across and beyond the organization, • Actively builds relationships and networks with others across and beyond HUTCHMED working constructively across organizational boundaries despite differences in interests, perspectives and need

We are looking for an experienced RA professional to join a large and growing pharmaceutical company. Interested candidates MUST HAVE the following experience (candidates without will not be considered): • Recent experience authoring original ANDA submissions (including relevant eCTD sections) for complex generics and/or combination products., • Must have submission experience with products with a Bio study component., • Must be open to working on site at least 2 days a week. Responsibilities: • Compile and submit ANDAs, supplements (CBE/PAS), annual reports, and labeling supplements in compliance with FDA requirements., • Author relevant eCTD sections using company templates and ensure files are properly formatted with bookmarks, hyperlinks, and metadata., • Evaluate proposed product and process changes against current FDA guidance and industry standards. Recommend appropriate filing strategies, timelines, and risk-based approaches for submission planning and execution., • Support regulatory strategy and submissions for complex generics and combination products (e.g., transdermal systems, injectables, drug-device combinations)., • Create and maintain internal templates, trackers, and tools to manage regulatory planning and combination product submissions., • Provide regulatory support for Design History Files (DHFs), ensuring consistency and alignment with FDA expectations for device related documentation., • Prepare formal meeting packages and briefing documents under GDUFA III, including pre-submission and mid-cycle meetings., • Coordinate with internal departments and external partners for documentation collection, timeline management, and regulatory compliance., • Lead regulatory activities for post-approval changes including site transfers, analytical method updates, container/closure system changes, and alternative sourcing of materials., • Participate in product development from early-stage formulation to final submission, incorporating FDA feedback and seeking regulatory guidance when appropriate., • Draft, review, and maintain product labeling and promotional labeling, ensuring alignment with current regulations and internal policies., • Review technical documentation and provide regulatory guidance to internal and external stakeholders. Ensure all submissions meet FDA standards, cGMP requirements, and Quality-by-Design (QbD) principles., • 5+ years’ experience in pharmaceutical regulatory affairs., • Experience with complex and combination products and knowledge of FDA expectations., • Experience with eCTD software, MSWord, Excel, Adobe Acrobat and other document processing software., • Independently compiled and filed ANDAs

Job Description Make the Road States (MRstates) is the national home for the second-generation Make the Road family of organizations in Connecticut, New Jersey, Pennsylvania and Nevada, this in addition to New York, that serves to uplift the voices of working-class, immigrants, women, LGBTQIA people, and people of color across the Make the Roads umbrella. From an operational spectrum it serves as the Finance and Human Resources Compliance Officers for the umbrella at large. Make the Road New Jersey (MRNJ) builds the power of immigrant and working class communities to achieve dignity and respect through community organizing, the provision of high quality legal and support services, transformative education and policy innovation. MRNJ is a project of Make the Road States. Founded in 2014, MRNJ operates centers and organizing hubs in Elizabeth, Passaic, Perth Amboy and Newark, NJ that reach thousands of immigrant and working class people of color each year. Our member-led organizing committees -- which work on the issues named above-- implement strategies to combat shared problems, and develop leadership and the capacity for civic participation. In the past four years, MRNJ has won more than 10 pro-immigrant and pro-worker policies, including the nation's first guaranteed severance law, landmark anti-wage theft legislation, occupational and drivers’ license for undocumented immigrants and a $15 minimum wage. We also provide an array of high-quality bilingual services including ESOL, legal services in the areas of immigration and workplace rights, workplace safety training and college access. This provision is included in a Union-represented collective bargaining unit, and specific employment terms and conditions are subject to collective bargaining. Current Opening: Since opening in 2014, Make the Road NJ has led some of the most dynamic and impactful worker organizing campaigns in the state. NJ workers have won landmark protections against wage theft, have passed laws guaranteeing paid sick leave, pushed for the establishment of an excluded workers fund during the COVID-19 pandemic, and in 2023 pushed for the passage of the historic Temporary Workers’ Bill of Rights. We now seek a Worker Organizer to strengthen our base and prepare groups of workers to take on the biggest challenges and campaign aggressively to win tangible victories in key industries. This role reports to the Director of Worker Organizing and Policy. The role will require in person work in one of our offices in Elizabeth, Passaic and/or Perth Amboy and travel throughout the state. The position would be ideal for an energetic, flexible organizer with a commitment to social justice, worker justice, and grassroots organizing. The candidate will work with MRNJ’s team of Worker Committee organizers, as well as with the broader organizing team, our lawyers and our communications specialists. Additionally, the Organizer will represent Make the Road New Jersey at coalition partner tables and help lead campaigns and coalitions. We are looking for a passionate, creative thinker with outstanding leadership skills who has the ability to develop member leadership and implement a variety of strategies to advance our campaigns. This is an excellent opportunity to sharpen your skills as an organizer and make lasting change alongside workers on the frontlines. Key Responsibilities but not limited to: • Execute campaign plans designed to mobilize workers around the most urgent issues in our state., • Lead teams of member-organizers through community outreach and actions, including door-knocking, rallies, protests, engagement with elected officials, etc., • Conduct outreach at warehouses, temp agencies and other workplaces, • Hold frequent one-on-one meetings with both current and prospective Worker Committee members, • Co-design and co-organize leadership development opportunities for members, • Engage the broader community and expand the Worker Committee’s base with popular education, • Build and hold organizing relationships with key partners, allies and elected leaders while representing MRNJ at key coalition partner tables, • Contribute to creating impactful and culturally-relevant messaging and aesthetics that elevate our campaigns, • Support the implementation and recruitment efforts to grow our membership based throughout the state., • Eligible to work in the U.S, • Required to be fully vaccinated with an FDA approved COVID-19 vaccine prior first day of employment., • Spanish/English fluency preferred;, • Have 2 years demonstrated experience in community or workplace organizing;, • Must be open to working some evenings and weekends, • Required travel across all our community centers and statewide, with some travel to Washington, DC and other geographies in the United States., • Must have a commitment to social justice and building leadership of immigrant and working class people of color, • Must have passion/knowledge of worker justice issues, • Must have experience working on organizing campaigns, • Self-starter with strong organizational skills and strong attention to detail, • Be highly professional and team oriented with a passion for excellence and eagerness to help the department meet our goals., • Ability to multi-task, prioritize, and complete assignments under strict deadlines with minimal supervision in a fast paced environment., • Ability to work under pressure required., • Have a working knowledge of spreadsheets, Microsoft Office suite, and using a database (ideally Salesforce) to run reports., • Flexible work schedule, some evenings or weekends required, • Strong verbal and written communication skills MRStates offers an excellent benefit package including health insurance, 401K, and generous paid vacation, sick, personal days. The salary range for this position is from $50,591 to $78,652 How to Apply: Please attach cover letter/resume and submit all documents to the Make the Road New States career center. Make the Road believes that social change is best achieved through grassroots community-based organizing that flows directly from and engages the community demanding the change. As a membership-based organization, we are committed to providing equal employment opportunities regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, criminal history, or Veteran status. We strongly encourage those from historically excluded groups to apply.

Job Description What makes Stephen Gould Exceptional. Founded through a passion for entrepreneurship, our success is due to the ingenuity and tenacity of our extraordinary teams, bringing people and ideas together. With Stephen Gould, everything is within reach including an exciting career opportunity. We want you to join our team and build on our incredible 80-years of excellence. Stephen Gould looks for people that want to design and develop exciting solutions for a variety of engaged and passionate clients across the global. With headquarters in Whippany, New Jersey, 40 locations throughout the U.S and operations in six countries outside the U.S, we have grown tremendously while maintaining staying true to our 5 Principles: Stephen Gould - 5 Principals Values and behaviors we look for: • Be committed to delivering the best results as a team, recognize that decisions may differ from individual opinion, succeed as a group., • Integrity and reliability show up every day in my work. Key Responsibilities • Project Info Liaison: Go-to source for status, risks, updates; push proactive communication; maintain real-time records., • Reporting: Deliver weekly updates, risks, milestones to leadership., • Collaboration:, • Partner with Packaging Managers on timing, samples, production timelines, and or Program Manager alignment., • Collaborate with Client Management Specialists and Sales Team on order tracking, customer needs, deliverables/specs, and client communication., • Customer Quotes: Build accurate, competitive quotes using existing cost data; include assumptions, lead times, MOQs; present professional packages; revise quickly., • New Project Timelines: Lead timeline creation—map critical path (design freeze, mold fab, range boards and color matching, printing, sampling, QA, trials); use established vendor data., • Sample Management: Coordinate receipt, inspect with Engineering for defects, functionality, color accuracy, and spec adherence; document, repackage, ship client-ready samples; escalate issues., • Schedule & Tasks: Maintain master schedules (MS Project/ERP) including current purchase orders of repeat items; assign/track tasks (mold approval, range boards and color matching, printing setup, QA, shipping); send reminders; escalate blockers., • Customer Requests: Capture, route, verify completion with uncompromising attention to detail., • Partner with Sales Team: Organize cost/timeline-accurate quotes + samples to win business., • Development Process Participation: Be part of the development process on customer calls to support needs/requests and keep projects on pace., • Project Oversight: Keep projects moving with oversight and behind-the-scenes support—lead full-cycle launches: custom molded components, range boards, color matching, and customer approvals. Qualifications • Education: Bachelor’s in Engineering (Packaging, Mechanical, Chemical, or Industrial preferred)., • Experience:, • 6+ years in cosmetics/personal care packaging PM., • Track record with CMs and brands: L’Oréal, Estée Lauder, Avon, Coty, Revlon, P&G, Unilever, Puig., • Success as info liaison, quoting (existing data), timeline creation, sample/engineering/QA/schedule management., • Hands-on with injection/blow/glass molding, range boards, color matching, and printing., • Supported sales via cost/timeline execution., • Worked with technical/client teams., • Skills:, • Experience with MS Project or similar PM softtware- ERP and timeline development., • Familiar with: molding processes, printing, FDA/EU, quality systems (CAPA/NCR), cost analysis (no sourcing) is highly desired., • Uncompromising attention to detail in sample/quote handling, execution, and documentation. Stephen Gould is an equal opportunity employer

Job Description Experience Candidates should possess the following skills: • 3+ years experience driving a forklift and Electric Pallet Jack single pallet., • Bilingual (English/Spanish / Chinese) preferred., • Strong knowledge of working in a Warehouse environment Dry and Cold., • Highly organized, with the ability to manage multiple task., • Forklift Operator is responsible for operating an electric powered industrial forklift to move, locate, relocate, stack, push, pull, tier, and count product and materials. The operator is accountable for the safe and efficient operations of the vehicle in a manner that meets UBL standards for quality, productivity, and accuracy., • Receive all inbound raw materials and packaging, • Checks delivered items against the delivery invoice/ P.O.s, • Inspect all received materials for defects, damage, and overall quality, • Ensure compliance with all shipping SOPS, communicating to Warehouse Manager any deviations, • Ensure all shipping paperwork is completed and processed in line with Standard Operating Procedures, • Transfer all raw materials and frozen goods to and from racks and freezer to correct locations, • Assist in periodic inventory counts and adjustments, • Use manual and powered pallet jacks, • Multiple types of powered forklifts are safely operated., • Follow quality, safety and good manufacturing processes (GMPs) are followed, • Comply with FDA, USDA, and HACCP standards, • Communicate with (or to) individuals or groups verbally and/or in writing, • Pull requisitions for Production., • Receive and unload trucks., • Stack and down stack pallets neatly and evenly to ensure safe transport. Equal Opportunity Employer: ATC Healthcare Services is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, age, sex, sexual orientation, gender identity, national origin, veteran or disability status or any other category protected by Federal, State or local law. M/F/D/V EOE