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Aquestive Therapeutics is hiring directly for several key positions, with Inizio Engage supporting the recruiting process. About Aquestive Therapeutics With more than 20 years of pioneering patient-centered innovation, we've transformed how millions access life-saving medications. Our track record speaks for itself: 6 FDA approvals, 2.5 billion doses delivered worldwide, and a presence across 6 continents. As we prepare to launch Anaphylm™, our latest breakthrough in overcoming patient barriers, we're building a sales team that shares our commitment to innovation that matters. The Role As a Therapeutic Specialty Representative (TSR), you’ll be on the front lines of a critical product launch, introducing Anaphylm to healthcare providers. Anaphylm has the potential to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis. If approved, people at risk for severe allergic reactions would have a device-free, needle-free epinephrine option. Similar in size to a postage stamp, Anaphylm is administered as a thin, dissolvable film placed under the tongue. As a Therapeutic Specialty Representative (TSR), you will educate healthcare providers on how Anaphylm is designed to address barriers that prevent patients from carrying and administering epinephrine, building trusted relationships to drive adoption of Anaphylm. This role is ideal for ambitious sales professionals who thrive in a launch environment and who want their work to have genuine clinical impact. Key Responsibilities Strategic Territory Development * Design and execute territory business plans that identify high-potential accounts and drive measurable market penetration * Analyze prescribing patterns, payer landscapes, and competitive dynamics to prioritize efforts and maximize ROI * Partner with Regional Sales Managers to align field execution with broader commercial strategy Clinical Education and Relationship Building * Deliver compelling, compliant clinical presentations that demonstrate Anaphylm's value in addressing unmet patient need * Build trust-based relationships with key prescribers, practice administrators, and healthcare stakeholders through consistent engagement and authentic dialogue * Navigate complex clinical objections with insight and empathy, positioning Anaphylm as the solution to real-world challenges Access and Pull-Through Excellence * Master payer coverage dynamics across your territory—national, regional, and local insurance landscapes * Collaborate with Market Access, to overcome prior authorization barriers and ensure seamless patient onboarding * Drive formulary wins and in-office pull-through by equipping providers with the tools and knowledge they need Flawless Execution * Orchestrate high-impact customer engagement programs including lunch-and-learns and speaker events * Maintain CRM excellence: capture detailed call notes, payer feedback, sampling activity, and strategic next steps with precision * Ensure 100% compliance with PDMA sampling requirements, AE/product complaint reporting, and promotional guidelines Field Intelligence * Serve as the eyes and ears of the organization, sharing customer insights, competitive intelligence, and best practices that inform strategy * Contribute to a culture of continuous learning and improvement across the sales organization Qualifications Required * Bachelor's degree * 3+ years of pharmaceutical, specialty, or B2B sales success with proven track record of exceeding targets * Deep understanding of payer coverage, prior authorization workflows, and access barrier navigation * Strong analytical skills with demonstrated ability to translate data into actionable territory strategies * Willingness to travel overnight 50% for customer meetings, conferences, and sales meetings Preferred * Launch experience in specialty or allergy markets. * Specialty pharmacy or hub services background * Experience selling products that address medication adherence or administration barriers Who Thrives Here * Mission-driven achievers motivated by outcomes results-oriented with passion for improving patient outcomes * Strategic hunters who combine creativity, persistence, and disciplined execution to drive market growth * Resilient and adaptable performers able to navigate obstacles, adapt quickly, and thrive in a competitive, fast-paced launch environment * Collaborative team players who elevate others while maintaining accountability for outcomes * Consultative and influential communicators who earn trust, educate customers, and drive conversion through insight and conveying value Compliance * Ensure field compliance with all company and industry standards, including: * Sampling and PDMA (if applicable) * Adverse Event (AE) and product complaint reporting * On-label and compliant promotional dialogue * CRM data quality and timely documentation * Maintain alignment with corporate policies, training, and legal/regulatory requirements. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected salary range: $125,000 - $150,000/per year. Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Job DescriptionProvides administrative and secretarial support for the vice president and department. RESPONSIBILITIES • Monitors and oversees facility operations for a large biotech site., • Troubleshoots and performs repairs on system issues involving electronic, electrical, pneumatic, hydraulic, and mechanical devices, Johnson Controls Metasys BMS, utility, and water systems., • Supervisor in charge of facility housekeeping staff for second shift., • Generates work orders in SAP, participates in site emergency response and Hazmat activities. Novartis Pharmaceuticals 01 Sep 2005 - 01 May 2014 ENGINEERING TECHNICIAN 1216 5th Avenue New York NY , 10029 OK to contact this employer? - No RESPONSIBILITIES • Repaired, maintained, and calibrated pharmaceutical manufacturing, production and packaging equipment.

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 Unit Pack is a family-owned and operated company with over 50 years of experience in packaging liquids, creams, gels, serums, oils, and pastes in single-use packages catering to your packaging needs. Our packaging solutions include customized designs, classic sachets, and affordable and high-quality pouches showcasing your brand. At our Certified Organic and FDA-registered facility, we maintain rapid changeover ability and consistent on-time delivery, ensuring that your needs are always met. Our long-standing partnerships in cosmetics, pharmaceuticals, and industrial industries have made us a trusted name in the business for over three generations. Job Summary: As a Machine Operator, you will be responsible for operating and maintaining the machines to ensure efficient production of high-quality goods. Your primary focus will be on inspecting packages, monitoring machine performance, and maintaining a clean and organized workstation. Attention to detail, physical strength, and technical skills are essential for this role. Requirements: ● The job requires the ability to lift up to thirty pounds without assistance. ● You should be able to stand for prolonged periods of time. ● Climbing tall equipment to replace parts is a frequent task, so it is essential to do so safely. ● You will be working in a loud production floor environment, and proper hearing protection is mandatory. ● You must have a keen eye for detail to continuously inspect and focus on small details of produced goods. ● Inspect 100% of packages during production, including checks on print quality, seams, welds, and fill volume. ● Maintain the correct position at all times while operating the machine. ● Keep the workstation clean and organized, properly arranging tool trays, scale tables, and roll tables. ● Keep the work station stocked with necessary supplies: alcohol, wipes, gloves… ● Assemble boxes and fill them with the correct number of packages while adhering to designated weight requirements. ● Replenish raw materials on printers and tube makers, while also disposing if waste properly ● Replace wear parts to maintain a high level of quality in production ● Line boxes with paper to check for leaks and perform leak tests on boxes containing paper. ● Clean the production line at required times following work instructions to prevent downtime, interruptions, and defective packages ● Identify and replace defective jaws on the machine. ● Empty the butt trim chip bucket and water collect bucket at the machine as needed. ● Perform visual inspection to ensure proper functioning of pumps and prevent air entrapment unless the order is complete. ● Clean pumps following standard operating procedures (SOPs) for pump cleaning at designated cleaning stations. ● Accurately complete all quality control paperwork, following instructions and performing necessary checks. ● Report any issues with paperwork to the quality control team promptly. ● Record all machine stoppages using the Down Time Log, communicating with mechanics to accurately document stations and actions performed. ● Complete all tasks outlined in the Machine Operators Work Instructions on a daily basis. ● Attend weekly Machine Operator meetings to stay updated on any changes or improvements. ● By diligently executing these responsibilities, you will contribute to the overall efficiency and productivity of the production process and ensure the delivery of high-quality goods to customers. *Please note that this job description is subject to change as needed based on the evolving requirements of the role and the production environment. Company DescriptionUnit Pack is a family-owned and operated company with over 60 years of experience in packaging liquids, creams, gels, serums, oils, and greases in single-use packages. Our packaging solutions include customized designs, classic sachets, and affordable and high-quality pouches showcasing brands. At our Certified Organic and FDA-registered facility, we maintain rapid changeover ability and consistent on-time delivery, ensuring that customer needs are always met. Our long-standing partnerships in cosmetics, pharmaceuticals, and industrial industries have made us a trusted name in the business for over three generations.Unit Pack is a family-owned and operated company with over 60 years of experience in packaging liquids, creams, gels, serums, oils, and greases in single-use packages. Our packaging solutions include customized designs, classic sachets, and affordable and high-quality pouches showcasing brands.\r\n\r\nAt our Certified Organic and FDA-registered facility, we maintain rapid changeover ability and consistent on-time delivery, ensuring that customer needs are always met. Our long-standing partnerships in cosmetics, pharmaceuticals, and industrial industries have made us a trusted name in the business for over three generations.

Job Description Auto-Chlor is now hiring an Electrical Engineer-Equipment Design to lead our engineering development initiatives. We’re looking for a leader who will contribute to our “People First” culture. This position would work in-office full-time at our facility in MEMPHIS, TN. What’s in it for you? • A people first culture where contributions and collaboration are encouraged and celebrated., • A competitive salary up to $150k annually with an excellent benefits package., • Ongoing wellness initiatives to improve your health and well-being. What are some of the day-to-day responsibilities? • Develops and implements solutions for dishwasher and dispensing innovation projects, including both new equipment development and existing equipment innovation. Projects vary in duration from two months to over a year based on Project Brief requirements., • Administers regulatory compliance with agencies such as NSF, CSA, UL, BOCA, ASSE, UPC, and Federal, State, and Local authorities. Provides support to the field sales team on regulatory issues, with an emphasis on maintaining customer equipment operation without disruption to business., • Provides technical support to field sales team, contractors, consultants, engineers, and architects., • Develops and manages technical documentation for design control and field use. Requirements: • Bachelor of Science in Engineering Degree or comparable years of work experience., • 5-10 years of electrical and electronic design experience, along with experience working with regulatory agencies. Experience in the commercial appliance industry is preferred., • Embedded Software/hardware design, • Knowledge of codes and standards for plumbing, sanitation, electrical, and building (NSF, CSA, UL, BOCA, ASSE, UPC, FDA), • Electrical/electronic circuit design, • CAD Modeling – Autodesk Inventor Preferred Location: 746 Poplar Ave Memphis, TN 38105 #PROFESSIONAL

Job Description Responsibilities include but are not limited to: Preparing and submitting customs entries: This involves preparing the necessary documentation and data to US Customs and Border Protection (CBP) and other government agencies like the FDA, Fish & Wildlife Service (FWS), USDA, etc. Transmission of Customs Entries to U.S. Customs for import shipments Ensuring compliance: Verify accuracy of documents (commercial invoices, etc.) and ensure compliance with US Customs regulations.. Coordinating with various parties: Communicate and coordinate with internal / external customers, carriers, freight forwarders, customs officials and other agencies to ensure smooth clearance of good Problem-solving: Resolve documentation discrepancies, Customs exams, FDA holds, or other issues related to Customs clearance. Receiving, reviewing, and processing import documentation for an assigned base of accounts Preparing daily activities including: preparing delivery orders and coordinating the pickup and delivery of cargo, filing ISF (Importer Security Filing), answering emails Processing documents through the system and interface and providing updates and communications for internal and external customers to produce timely and compliant transactions Tracing key transaction information such as HBL, commercial invoice, and other required documents to determine if record is available Corresponding with overseas agents and clients Working with steamship lines/airlines/trucking companies to obtain quotations and handle the movement of freight Developing and maintaining excellent customer service to internal and external customers Preparing quotations Handling the files from A to Z Responsible to ensure legal compliance, provide import guidance and control within government rules and regulations. Job Requirements: Minimum 2- 4 years of experience in Import Customs Clearance operations Knowledge of current and historical Customs regulations, Harmonized Tariff Schedule, and related directives of government agencies (including but not limited to Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and United States Agriculture Department (USDA) is a plus) Be able to work independently, multi-task, be a team player and work in a fast-paced environment Possess excellent written and verbal communication skills Have computer skills and knowledge of Microsoft Outlook, Excel, Word and Access Experience with the handling of hazardous materials a plus

Job DescriptionDescription: Leading Freight Forwarder / NVOCC/ Customs House Broker/ Tank Container Operator, with locations in 24 countries and over 3300 employees strong, is seeking a highly motivated and organized individual to fill the position of Import Customer Service Representative – Customs Entry Writer in our Jersey City, NJ office. Responsibilities include but are not limited to: • Preparing and submitting customs entries: This involves preparing the necessary documentation and data to US Customs and Border Protection (CBP) and other government agencies like the FDA, Fish & Wildlife Service (FWS), USDA, etc., • Transmission of Customs Entries to U.S. Customs for import shipments, • Ensuring compliance: Verify accuracy of documents (commercial invoices, etc.) and ensure compliance with US Customs regulations., • Coordinating with various parties: Communicate and coordinate with internal / external customers, carriers, freight forwarders, customs officials and other agencies to ensure smooth clearance of good, • Problem-solving: Resolve documentation discrepancies, Customs exams, FDA holds, or other issues related to Customs clearance., • Receiving, reviewing, and processing import documentation for an assigned base of accounts, • Preparing daily activities including: preparing delivery orders and coordinating the pickup and delivery of cargo, filing ISF (Importer Security Filing), answering emails, • Processing documents through the system and interface and providing updates and communications for internal and external customers to produce timely and compliant transactions, • Tracing key transaction information such as HBL, commercial invoice, and other required documents to determine if record is available, • Corresponding with overseas agents and clients, • Working with steamship lines/airlines/trucking companies to obtain quotations and handle the movement of freight, • Developing and maintaining excellent customer service to internal and external customers, • Preparing quotations, • Handling the files from A to Z, • Responsible to ensure legal compliance, provide import guidance and control within government rules and regulations. Requirements: Job Requirements: · Minimum 2- 4 years of experience in Import Customs Clearance operations · Knowledge of current and historical Customs regulations, Harmonized Tariff Schedule, and related directives of government agencies (including but not limited to Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and United States Agriculture Department (USDA) is a plus) · Be able to work independently, multi-task, be a team player and work in a fast-paced environment · Possess excellent written and verbal communication skills · Have computer skills and knowledge of Microsoft Outlook, Excel, Word and Access · Experience with the handling of hazardous materials a plus Our Benefits include: · Medical · Dental · Vision · Flexible Spending Account (Medical and Dependent Care) · 401(k) with company match · Company paid Life Insurance, Short-Term Disability and Long-Term Disability · Paid Holidays plus PTO and Sick Leave · Voluntary Time Off · Employee Assistance Program · Tuition Reimbursement · Employee Referral Program · Employee Discounts When applying, the candidate should include salary requirement. Background check required. Only those considered for the position will be contacted. Thank you for your interest.

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 Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role We are seeking an experienced IRB Coordinator to join our exceptional team as a full-time Vitalief employee. In this role, you will support a leading hospital research center in Livingston, NJ, administering and overseeing Institutional Review Board (IRB) activities to ensure compliance with federal, state, and institutional regulations governing human subjects research. This role supports investigators, staff, and IRB members in the preparation, review, and approval of research protocols, while also assisting with Nussbaum grant activities. WHY VITALIEF? • Contribute to advancing scientific discoveries that improve patient lives., • PEOPLE FIRST culture with opportunities for growth and innovation., • Competitive benefits including: 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans. Responsibilities: • Under the direction of the Director of Graduate Medical Education and Clinical Research, coordinate and manage all IRB activities, meetings, and communications., • Review protocol submissions for completeness and accuracy; recommend appropriate level of review., • Draft and issue correspondence reflecting IRB deliberations and decisions., • Provide regulatory and methodological guidance to investigators, staff, students, and IRB members., • Maintain compliance with OHRP, FDA, ICH/GCP, and institutional regulations., • Manage IRB databases, tracking systems, and protocol documentation., • Assist with emergency use protocols and special meetings as needed., • Schedule and support Institutional Research Committee meetings, prepare agendas/minutes, and follow up on action items., • Collaborate with other system IRB Coordinators and departmental staff., • Bachelor’s degree in a scientific or health-related field required; Master’s degree preferred., • Three (3) years of experience in clinical research and research administration, including two (2) years of IRB operations experience., • Strong understanding of IRB regulations, ethical research standards, and ICH/GCP guidelines., • Excellent written and verbal communication skills., • Ability to demonstrate professionalism, clear communication, and respect in all interactions., • Passionate in supporting teamwork and collaborative problem-solving., • Apply continuous quality improvement principles to research operations., • Work independently with accountability, sound judgment, and openness to feedback., • Strong organizational and time management abilities; must be self-motivated and able to multi-task on a variety of projects., • Detail-oriented with strong organizational and follow-up skills., • Proficiency with Microsoft Office (Word, Excel, PowerPoint); database management experience preferred., • Certified IRB Professional (CIP®) is a plus., • Knowledge of medical terminology preferred. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR oj96ccgxpc

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 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 DescriptionJob Title: REMOTE Territory Sales Manager – Specialty Chemicals & APIsCompensation: $100,000–$130,000 base + performance incentives Location: Remote (U.S.) Industry: Specialty Chemicals / APIs / Pharmaceutical Intermediates Overview A global manufacturer of specialty chemicals and pharmaceutical ingredients is expanding its North American commercial team. This is a high-impact sales role focused on growth within key verticals including iodine derivatives, intermediates for anti-cancer and contrast media, and active pharmaceutical ingredients (APIs). The role is modeled on a proven sales structure used for similar markets, emphasizing relationship management, business development, and strategic positioning across nutraceutical, pharma, and fine chemical sectors. Key Responsibilities * Drive sales growth across the North American territory for specialty and pharmaceutical-grade chemical ingredients. * Identify, target, and close new business opportunities across the following categories: * Iodine derivatives * Anti-cancer drug intermediates * X-ray and contrast media intermediates * APIs and stomach-related APIs * Develop and maintain relationships with key accounts, distributors, and manufacturers. * Collaborate closely with global production and regulatory teams to ensure compliance and delivery. * Analyze market trends and identify high-value prospects for long-term partnerships. * Represent the company at key trade shows and industry events (e.g., IBIE, CPhI, SupplySide West). * Prepare detailed reports and forecasts for executive management. Qualifications * Bachelor’s degree in Chemistry, Chemical Engineering, or related field (advanced degree a plus). * Minimum 5 years of experience in B2B sales of specialty chemicals, APIs, or pharmaceutical intermediates. * Proven track record of achieving revenue goals and building strategic partnerships. * Familiarity with regulated markets (FDA, REACH, GMP) preferred. * Exceptional communication, negotiation, and presentation skills. * Self-motivated, entrepreneurial mindset; able to operate with minimal supervision. Compensation & Benefits * Base salary between $100,000 and $130,000, depending on experience. * Performance-based commission and annual bonus structure. * Health coverage, paid time off, and travel reimbursement. * Long-term growth opportunity with a global chemical leader expanding in the U.S. market.

Job Description Hudson Regional Health System (HRHS) seeks a results-driven and collaborative laboratory leader to oversee diagnostic and clinical laboratory operations for Bayonne University Hospital and Secaucus University Hospital. The Director is accountable for ensuring regulatory compliance, service quality, and operational efficiency across both campuses, supporting HRHS’s mission of delivering exceptional, patient-centered care. Position Summary The Director manages all inpatient and outpatient laboratory functions for Bayonne and Secaucus hospitals, including technical operations, staffing, compliance, and financial performance. The position ensures consistency, quality, and innovation across both campuses while supporting HRHS’s broader laboratory strategy. This position reports directly to the System Chief Operating Officer. Key Responsibilities • Oversee daily operations of clinical laboratory services across Bayonne and Secaucus facilities., • Ensure full compliance with CLIA, CAP, Joint Commission, OSHA, FDA, and applicable state regulations., • Supervise laboratory leadership teams, including supervisors, and technical personnel., • Maintain appropriate staffing, scheduling, and budgetary controls to ensure cost-effective performance., • Collaborate with hospital executives, medical directors, and clinical departments to support patient care initiatives., • Lead continuous quality improvement and performance optimization efforts across both sites., • Manage equipment procurement, service contracts, and laboratory supply chains., • Partner with IT and system teams to standardize data, reporting, and laboratory information systems., • Track and report KPIs, turnaround times, and quality metrics to system leadership., • Serve as the administrative and operational leader for laboratory services at Bayonne and Secaucus campuses., • Collaborate directly with the System COO and other hospital executives to align goals and share best practices., • Work closely with other HRHS laboratory leaders to advance system standardization and integration., • Bachelor’s degree in Clinical Laboratory Science, Medical Technology, or related field required; Master’s degree preferred., • Current licensure and national certification (ASCP, NCA, or AMT) required., • Minimum 7 years of progressive experience in laboratory management, including multi-site leadership preferred., • Reference Lab experience preferred., • Deep understanding of regulatory requirements, budget management, and process improvement methodologies., • Exceptional interpersonal and leadership skills, with the ability to collaborate effectively across departments.

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 a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility. The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada). Overall Responsibilities For Quality Operations And Initiatives, Including • Quality Assurance management:, • Documentation control (master batch record, specification and method), • Batch record review and product disposition, • Investigations, complaints, deviations, CAPAs, APRs, • Production and Pharmaceutical Development support, • APRs, GMP training and SOP review, • Validation / qualification documentation review and approval, • QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site, • Develop, maintain, and enhance training programs and systems, • Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives., • Must be able to move about the facility, • Experience with FDA Audit, • Extensive knowledge of US and EU current Good Manufacturing Practices, • Experience with a CDMO would be preferable, • In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for: i). Quality Compliance management: ii). All audits, internal, external - regulatory, client and vendor iii). Vendor management program iv). QA Agreements with clients & contractors v). License renewals Company DescriptionWe are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..We are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..

Job Description About Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role We are seeking an experienced IRB Coordinator Consultant to join the Vitalief team as a contractor. In this role, you will support a leading hospital research center in Livingston, NJ, administering and overseeing Institutional Review Board (IRB) activities to ensure compliance with federal, state, and institutional regulations governing human subjects research. This role supports investigators, staff, and IRB members in the preparation, review, and approval of research protocols, while also assisting with Nussbaum grant activities. Engagement Details • Work Hours: 40 hours per week (8am to 4pm M-F), • Work Location: 100% on-site in Livingston, NJ., • Contract Duration: 6 months (possible extension), • Pay Rate: Market competitive (depends on experience level) Responsibilities:, • Under the direction of the Director of Graduate Medical Education and Clinical Research, coordinate and manage all IRB activities, meetings, and communications., • Review protocol submissions for completeness and accuracy; recommend appropriate level of review., • Draft and issue correspondence reflecting IRB deliberations and decisions., • Provide regulatory and methodological guidance to investigators, staff, students, and IRB members., • Maintain compliance with OHRP, FDA, ICH/GCP, and institutional regulations., • Manage IRB databases, tracking systems, and protocol documentation., • Assist with emergency use protocols and special meetings as needed., • Schedule and support Institutional Research Committee meetings, prepare agendas/minutes, and follow up on action items., • Collaborate with other system IRB Coordinators and departmental staff., • Bachelor’s degree in a scientific or health-related field required; Master’s degree preferred., • Three (3) years of experience in clinical research and research administration, including two (2) years of IRB operations experience., • Strong understanding of IRB regulations, ethical research standards, and ICH/GCP guidelines., • Excellent written and verbal communication skills., • Ability to demonstrate professionalism, clear communication, and respect in all interactions., • Passionate in supporting teamwork and collaborative problem-solving., • Apply continuous quality improvement principles to research operations., • Work independently with accountability, sound judgment, and openness to feedback., • Strong organizational and time management abilities; must be self-motivated and able to multi-task on a variety of projects., • Detail-oriented with strong organizational and follow-up skills., • Proficiency with Microsoft Office (Word, Excel, PowerPoint); database management experience preferred., • Certified IRB Professional (CIP®) is a plus., • Knowledge of medical terminology preferred. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR lfKp3BPFdR

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 DescriptionJob Title: Adobe Campaign Lead Developer Location: U.S.-based (onshore). Hybrid/remote (Preferred but not restricted to Philadelphia or Atlanta USA). Type: Full-time, client-facing Role Summary Lead end-to-end strategy and execution of email and direct mail programs on Adobe Campaign (v8/Classic) for a major telecommunications client. Own campaign intakebuildQAlaunchreporting, guide an offshore/onshore pod, and partner with marketing, data, and CRM teams to deliver timely, compliant, high-impact communications. Key Responsibilities • Campaign leadership: Own calendar, briefs, targeting rules, build/QA, and launches for Email & Direct Mail; ensure on-time, error-free delivery with clear stakeholder updates., • Audience & personalization: Translate business asks into segments and dynamic content using Adobe Campaign data model and templates; manage suppressions/seed lists and opt-in/opt-out compliance., • Direct Mail orchestration: Coordinate list pulls, QA, creative specs, vendor handoff, and match-back reporting for DM alongside digital touchpoints., • Cross-functional partnership: Work with client data/analytics teams to ensure smooth execution across martech., • Governance & quality: Uphold brand, legal, and privacy standards (CAN-SPAM/GDPR/CCPA); maintain documentation, playbooks, and campaign audit trails., • Excellent stakeholder communication, prioritization, and project leadership in a fast-paced, enterprise environment., • Strong segmentation and campaign workflow experience; comfortable translating requirements into executable builds and QA plans., • Working knowledge of SQL for audience creation and troubleshooting; comfort with HTML/CSS for email template QA., • Familiarity with integrations across CRM systems (Salesforce/Microsoft Dynamics) and Adobe stack (AEP/Analytics/Target) is a plus.Nice to Have - Adobe Campaign certification (ACE), experience with transactional/real-time messaging, and exposure to FDA/API/SFTP integrations. This is a remote position.

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 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 Job Title : Regulatory Support Location: Basking Ridge NJ Remote Option: Yes. But the candidate should be available to attend customer meetings twice in a month Requirements Mandatory skills: -experience in pharmaceutical environment. -Experience in regulatory environment is required. -High level exposure or knowledge about FDA inspection and internal audit process. -Knowledge or exposure on Veeva RIM Submission/Archive, Publishing etc. Job Title: Consultant JD details : -Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance. -Represents Regulatory Affairs on cross-functional project teams. -Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents. -Work with subject matter experts, and cross functional departments to support business needs. -Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance & validation. -Gather and assemble information necessary for submissions in accordance with regulations/guidance. -Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions, as necessary. -Conduct review of published submissions to ensure consistency and compliance with regulatory requirements. -Maintain knowledge of local and global regulatory submission requirements. -Maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures &directives. -Provide Regulatory Affairs support during internal and external audits and inspections. -Exposure in Change management process, requirement gathering, qualifying the changes etc., -Actively participate in the development of Regulatory Operations processes like SOPs/GOPs, Work instructions, Checklist, templates etc. -Consistently support for regulatory systems access and change management. -Responsible for communicating business process improvements, business related issues, status updates or opportunities. Qualifications: -Bachelors’ degree, preferably in a life science or a related field -5 to 10 years of experience in pharmaceutical environment. -Experience in regulatory environment is required. -Excellent written, verbal communication and presentation skills. -High level exposure or knowledge about FDA inspection and internal audit process.

Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: • Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs), • Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity, • Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data, • Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents, • Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports), • Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC, • Demonstrated ability to lead others to complete complex projects, • Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines, • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment, • Organizational expert within the nonclinical subject area, • Excellent written/oral communication and strong time and project management skills, • Ability to attend regular team meetings, lead client meeting and CRMs, • Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars, • Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)Requirements:, • BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control, • Knowledge of GLP, ICH guidelines, and applicable regulatory requirements, • 2+ years of pharmaceutical regulatory nonclinical writing experience, • Strong writing and analytical skills, • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred uuQhjdtYkG

Job Description EHS Specialist POSITION OBJECTIVE This position will implement and maintain FPC USA’s EHS (Environment, Health and Safety) management system to ensure all aspects of the EHS programs are in compliance with local, state, and federal regulations, adhering to corporate EHS policies, procedures, industrial standards and ISO requirements (e.g. ISO 14001, 45001, 14040 and 1467). Additional responsibilities include EHS compliance audit, training scheduling, corrective action tracking, and other EHS related activities (e.g. Product safety, DOT/SDS and Product LCA assessment). MAJOR AREAS OF ACCOUNTABILITY • Implements and maintains FPC USA’s EHS management system to ensure compliance with local, state, and federal regulations, industrial, ISO standards and corporate policies., • Acts as a liaison to work with plant site EHS personnel to ensure sites’ and corporate EHS programs are aligning with each other and meet local, state, federal regulatory requirements and applicable industrial standards., • Coordinates with plant sites for EHS management system implementation and regulatory compliance audit, scheduling, and corrective action tracking., • Acts as Corporate EHS Master Training Plan PIC (person-in-charge) for developing, maintaining, scheduling and tracking progress of training for EHS related programs, • Utilizes knowledge management system (KMS) “Auditor” to maintain audit protocols, track audit findings, corrective actions and to verify completion for continue improvement., • Assists with stakeholders to monitor new and amended Federal EHS regulations and industrial standards and prepare regulatory memo for Management as necessary to ensure compliance., • Assists in maintaining corporate procedures (e.g. Product Stewardship manual), policies and guidance documents in conform to the company’s document retention procedures. (i.e. Intranet), • Works with Product Stewardship team to develop and maintain FPC regulatory database including ImageWave SDS database. QUALIFICATIONS • 5 years of work experience in chemical, engineering, safety, environment, or related scientific discipline., • Training and/or auditing experience in EHS management systems and/or ISO standards, • General knowledge of petrochemical and plastics production beneficial, • Experience in working and communicating with different staff departments (e.g. Sales, production, technical, et al.), • Strong knowledge of chemical, environmental, EHS and other scientific principles., • Knowledge of the structure of U.S. regulations (e.g. EPA, OSHA, and FDA) and ISO standards.Company DescriptionFounded in 1978, Formosa Plastics Corporation, U.S.A. (Formosa Plastics) is a growing, vertically-integrated supplier of plastic resins and petrochemicals. With annual revenues of more than $5 billion, we employ over 2,800 people who operate 20 production units in six business divisions - Olefins, Polyolefins, Vinyl, Specialty Polyvinyl Chloride, Chlor-Alkali, and Oil & Gas. Formosa Plastics offers a full line of polyvinyl chloride, polyethylene and polypropylene resins, caustic soda and other petrochemicals that deliver the consistency, performance and quality that customers demand. We market our polypropylene and polyethylene resins under the Formolene® tradename; we market our suspension PVC and specialty (dispersion) PVC resins under the Formolon® tradename. We also produce and sell caustic soda, ethylene dichloride, commercial bleach and hydrochloric acid. We are committed to supplying the highest quality products and services to our customers, providing a safe and healthy workplace for our employees and contributing to the quality of life in the communities where we operate. This commitment is made possible through our dedicated people, consistent products, continued protection of the environment and ongoing investments in new product development, quality control systems and safe, modern and energy-efficient production facilities. Formosa Plastics is a privately held company headquartered in Livingston, New Jersey. Our core business, producing plastic resins and petrochemicals, takes place at three wholly-owned chemical manufacturing subsidiaries located in Delaware City, Delaware, Baton Rouge, Louisiana and Point Comfort, Texas.Founded in 1978, Formosa Plastics Corporation, U.S.A. (Formosa Plastics) is a growing, vertically-integrated supplier of plastic resins and petrochemicals. With annual revenues of more than $5 billion, we employ over 2,800 people who operate 20 production units in six business divisions - Olefins, Polyolefins, Vinyl, Specialty Polyvinyl Chloride, Chlor-Alkali, and Oil & Gas.\r\n\r\nFormosa Plastics offers a full line of polyvinyl chloride, polyethylene and polypropylene resins, caustic soda and other petrochemicals that deliver the consistency, performance and quality that customers demand. We market our polypropylene and polyethylene resins under the Formolene® tradename; we market our suspension PVC and specialty (dispersion) PVC resins under the Formolon® tradename. We also produce and sell caustic soda, ethylene dichloride, commercial bleach and hydrochloric acid.\r\n\r\nWe are committed to supplying the highest quality products and services to our customers, providing a safe and healthy workplace for our employees and contributing to the quality of life in the communities where we operate. This commitment is made possible through our dedicated people, consistent products, continued protection of the environment and ongoing investments in new product development, quality control systems and safe, modern and energy-efficient production facilities.\r\n\r\nFormosa Plastics is a privately held company headquartered in Livingston, New Jersey. Our core business, producing plastic resins and petrochemicals, takes place at three wholly-owned chemical manufacturing subsidiaries located in Delaware City, Delaware, Baton Rouge, Louisiana and Point Comfort, Texas.

Job Description Job Duties: Performs and interprets automated and manual testing procedures on blood, urine and fluid specimens in the laboratory. Evaluates specimen/test orders for acceptance/rejection according to guidelines; accessions specimens accurately. Meets established TAT and productivity standards. Recognizes and resolves errors/discrepancies or problems and notifies appropriate personnel. Is proficient with all IT systems; can order, cancel, retrieve result, review work lists, sample collections, and test status. Addresses critical results and delivers STAT results properly according to policy. Correlates results with diagnosis and compares previous results if necessary. Can operate all Laboratory testing instruments; can recognize, troubleshoot and resolve instrument issues. Ensures proper function, maintenance and QC of each instrument; ensures compliance with QC, maintenance, temperature and reagent records. Performs proficiency testing and quality audits as needed. Ensures compliance with JCAHO, FDA, CAP, AABB and NJDOH. Maintain the record of reagents and supply; reports reagents shortage to the supervisor or designee; ensures that all reagents used for testing are in date and show no signs of drift or contamination as indicated in the daily QC data. Assists with training new employees, participates in teaching students. Demonstrates knowledge and follows to all department safety procedures and policies. Ensures proper handling of chemical and bio-hazard materials. Works weekdays, weekends and holidays as scheduled. Conducts personal business on non-productive time, limits socializing to ensure the work flow continues uninterrupted. Shows leadership quality; assumes responsibility in absence of supervisor. Attends department meetings and participates in continue education. EDUCATION + EXPERIENCE REQUIREMENTS: BS degree from an accredited institution with a major in medical technology. Minimum of 1 year clinical laboratory experience, which may be concurrent or subsequent to education, required. MT (ASCP) or equivalent certification desired. May be required to meet specific state requirements. CREDENTIALS + QUALIFICATIONS: Degrees from foreign institutions will require credential equivalency evaluation. Ability to provide excellent customer service internally and externally. Possess superior written and verbal communication skills. Ability to read, understand and follow detailed procedures. Analytical, numerical and reasoning abilities necessary. Proven skills of critical thinking, problem solving, and decision making. Ability to prioritize, organize, and handle a high volume workload efficiently essential. Good close vision and color perception required.

Job Description Our client in Fairfield, NJ is looking for an onsite, direct hire Manufacturing Industrial Engineer. Pay: $120k-$130k The ideal candidate will have an engineering background in mechanical engineering, industrial engineering, systems engineering, value engineering, or related engineering field with concentrated technical knowledge and previous experience in precision metals and plastics manufacturing and/or complex finished device assemblies. Responsibilities: • This role is fundamentally based on long-standing best practices in industrial engineering principles: identifying waste, defining value streams, productivity optimization, kanban setups, takt time studies, labor tracking, ergonomics, material flow, pFMEA, and similar Lean Six Sigma tools., • Support new business development with the purpose of generating accurate and detailed costing proposals that exceed customer expectations for quality, price, and delivery., • Bachelor's degree in Engineering (Mechanical, Industrial engineering, Systems engineering, Value engineering), • Minimum of 5 years of experience in value engineering, industrial engineering, manufacturing costing, or related role in the manufacturing industry, with specific experience utilizing industry 4.0 best practices and/or Lean, • Experience working for a Contract Manufacturer or OEM, • Strong engineering background with a solid understanding of manufacturing processes, materials, and equipment, • Ability to identify the best possible manufacturing processes, • Proficiency in using SolidWorks or equipment CAD/CAM software packages for estimating and DFM purposes, • Experience in product level design for manufacture (DFM), • Ability to collaborate across engineering Centers of Excellence for multi-plant vertically integrated proposals, • Excellent analytical and problem-solving skills, • Strong attention to detail and accuracy, • Effective communication and interpersonal skills, • Ability to work independently and as part of a cross-functional team, • Knowledge of industry standards and best practices in cost estimation

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 Job description Granulation Technology, Inc. is a leading pharmaceutical manufacturer specializing in high-quality OTC (over-the-counter) products. As a fast-growing, Indian-owned and majority women-owned company, we are committed to excellence, innovation, and customer satisfaction. Role Overview: We are seeking a results-driven Pharmaceutical OTC Sales Representative to expand our market presence, secure new accounts, and maintain strong relationships with key customers. This is an exciting opportunity for a sales professional with experience in the pharmaceutical OTC industry. Responsibilities: ✅ Identify and develop new sales opportunities within the OTC pharmaceutical market. ✅ Build and maintain relationships with distributors, retailers, and healthcare providers. ✅ Present and promote our OTC products to potential clients. ✅ Negotiate contracts, pricing, and supply agreements. ✅ Stay updated on industry trends, competitor activity, and market demands. ✅ Collaborate with internal teams (marketing, regulatory, and logistics) to ensure customer satisfaction. ✅ Meet or exceed sales targets and KPIs. Qualifications: Experience: 10+ years in OTC pharmaceutical sales. Skills: Strong negotiation, relationship-building, and communication skills. Knowledge: Familiarity with the OTC market, retail distribution, and pharmacy channels. Self-Motivated: Ability to work independently and drive results. Travel: Willingness to travel as needed for client meetings and industry events. Why Join Us? ✨ Opportunity to work with a growing pharmaceutical company. ✨ Competitive salary with uncapped commission potential. ✨ Flexible work environment with career growth opportunities. ✨ Be part of a dynamic, diverse, and innovative team. Company DescriptionGranulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.Granulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.

Job Description Position Overview: Hudson River Imaging is seeking a skilled and compassionate Mammography Technologist to join our team. The ideal candidate will be experienced in operating the Siemens Revelation mammography system, dedicated to delivering high-quality patient care, and committed to maintaining the highest standards of imaging and safety in accordance with ACR, MQSA, and state guidelines. Key Responsibilities: * Perform screening and diagnostic mammography examinations using the Siemens Revelation system. * Ensure optimal image quality while minimizing radiation exposure in compliance with ALARA principles. * Prepare and position patients for mammographic procedures, ensuring comfort, dignity, and safety. * Verify patient identification, review medical history, and explain exam procedures. * Collaborate with radiologists, technologists, and clinical staff to support timely and accurate diagnoses. * Perform daily quality control and equipment checks in accordance with ACR and FDA requirements. * Maintain accurate patient records and documentation in PACS/RIS. * Stay current with new mammography techniques, regulations, and continuing education requirements. Qualifications: * ARRT (R)(M) certification required. * Current state radiologic technologist license. * Minimum 1 year of experience in mammography; Siemens Revelation system experience strongly preferred. * Knowledge of ACR accreditation standards and MQSA compliance. * Strong interpersonal and communication skills with a focus on patient-centered care. * Ability to work independently and collaboratively in a fast-paced imaging environment. Preferred Experience: * Familiarity with tomosynthesis (3D mammography) workflows. * Experience assisting with breast biopsy procedures a plus. Why Join Us: * Work with state-of-the-art imaging technology, including Siemens Revelation mammography systems. * Supportive, team-oriented environment focused on excellence in patient care.

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 Come join CCRM Fertility, a global pioneer in fertility treatment, research, science, specializing in IVF, fertility testing, egg freezing, preimplantation genetic testing, third party reproduction and egg donation. As a member of CCRM Fertility’s diverse team of professionals, you will be a part of helping families grow and changing lives. We take pride in providing our employees with meaningful employment, a supportive culture, and a well-balanced personal & work life alignment. For more information, visit Work Location: Department: Laboratory Work Schedule: Monday-Friday (8:00am-4:30pm) What We Offer Our Team Members: • Generous Paid time-off (PTO) and paid holidays, • Medical, Dental, and Vision Insurance, • Health benefits eligible the first day of the month following your start date., • 401(k) Plan with Company Match (first of the month following 2 months of service), • Basic & Supplement Life Insurance, • Employee Assistance Program (EAP), • Short-Term Disability, • Flexible spending including Dependent Care and Commuter benefits., • Health Savings Account, • CCRM Paid Family Medical Leave (eligible after 1 year), • Supplemental Options (Critical Illness, Hospital Indemnity, Accident), • Professional Development, Job Training, and Cross Training Opportunities, • Bonus Potential, • Potential for Over-time Pay (Time and a half), • Holiday Differential Pay (Time and a half), • Assemble, organize, and file patient charts, freeze cards, FDA paperwork, and consent forms; conduct quality assurance/control of patient charts according to CAP guidelines., • Monitor lab emails, phones, and EMR, to answer questions, address requests, direct to appropriate resource, and follow-up through completion., • Generate daily surgery schedule for OR and IVF Lab; coordinate with the Doctor(s) and IVF staffs’ schedule., • Maintain all active ART patients in the IVF portal, verify accuracy of patient data, demographics, procedures, etc., • Coordinate daily ART procedures (egg retrievals, embryo transfers, male infertility procedures, egg warms, rebiopsy, non-invasive CCS, and EEB banking warm for culture); ensure patients and IVF staff are informed., • Assign incubator location for IVF Lab patients, enter patient information in Electronic Witnessing system, and affix labels on charts, incubators, media setup, and patient wristband., • Scan completed IVF/FET lab forms into patient EMR for Doctor/Nurse reference and ensure IVF/FET cycles are sent to business office and genetics., • Collect and input on-going SART data, audit charts for required information, transfer SART data from EMR into current database, and coordinate SART reporting to meet CDC requirements., • Interpret ART notes to enter and place orders in IVF Laboratory information system (LIS) and ensure Genetics’ CCS results are recorded in LIS., • Assist cryopreservation specialist with embryo scheduling, physical cyro-inventory, and embryo shipment documentation., • Maintain/update Cryoinventory database, Transfer database, and Harvest database; assist with data manipulation and presentation as needed., • Obtain/maintain Mayo Clinic’s “Shipping and Receiving Hazardous Materials” certification., • Serve as a witness to the Embryologist during CCS processing, vitrification, and warming., • Review disposition and dispose of embryo(s)/oocytes and maintain accurate records., • Understand/assess potential domestic violence and child abuse and know reporting responsibilities; will report concerns to IVF Laboratory Supervisor or Medical Director., • High School diploma or GED certification required., • Associates degree or higher preferred., • Medical lab experience preferred. CCRM’s Compensation: The salary range represents the national average compensation for this position. The base salary offered will vary based on location, experience, skills, and knowledge. The pay range does not reflect the total compensation package. Our rewards may include an annual bonus, flexible work arrangements, and many other region-specific benefits. Pre-Employment Requirements: All offers of employment are conditional upon the successful completion of CCRM Fertility’s onboarding process, including verification of eligibility and authorization to work in the United States. This employer participates in the E-Verify Program in order to verify the identity and work authorization of all newly hired employees. Equal Employment/Anti-Discrimination: We are an equal-opportunity employer. In all aspects of employment, including the decision to hire, promote, discipline, or discharge, the choice will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Job Description Director, Business Development - Clinical Research Director, Clinical Business Development Full Time Remote-USA Based Reports to: Senior Vice President, Clinical Services Frontage Laboratories Inc. Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage’s core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials. Frontage Clinical Services At Frontage, we leverage more than 25 years of experience to develop a unique approach to overcome the challenges of every clinical study, while maximizing efficiency and mitigating risk. We apply best practices in study design and execution to advance each study to completion. Responsibilities: • Secure and retain business through professional, consultative, and proactive sales activities directed at key decision makers, • Strong negotiating skills, knowledge of legal contracts and experience with RFIs/RFPs and competitive bidding processes, • Analyze potential opportunities and develop sales plans for each target account, develop in-depth knowledge of the customer organization, • Ensure appropriate strategy/solution is proposed to clients, • Monitor actions and results against plans, • Lead client visits to the Frontage facilities, • Coordinate with scientific and operations staff to prepare and lead the sales presentations, present comprehensive proposals, and lead follow-up activities, • Monitor sponsor satisfaction by regular communication with the clients/sponsors, • Record all client/sponsor sales related (opportunities, CDA, MSA, Site Visits, Face to Face Meetings, etc.) activities in CRM (salesforce) system, • BS degree or above, life science preferred., • 3+ years’ experience in a clinical operation role and /or 1+ years’ experience selling early-stage clinical research services., • Solid understanding of the principles of drug discovery and development., • Knowledge and experience in DMPK & Safety Toxicology, • Knowledge and understanding of FDA, GCP, and ICH regulations and guidance, • Highly proficient in using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel., • Attention to detail and ability to work simultaneously on multiple priorities. Able to adapt and be flexible to changing priorities., • Excellent oral and written communication skills., • Ability to travel.

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 .

Job DescriptionDescription: AAF International is an Equal Opportunity Employer M/F/Disability/Veteran. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, sexual orientation, gender identity, national origin, citizenship, veteran status, uniform servicemember status, age, disability or any other legally recognized protected personal characteristics. Certification Tech to work at various customer sites throughout New Jersey and New York. This successful team player will perform HEPA filtration certification, service, and preventive maintenance in a wide variety of Cleanroom and containment applications. you mut be able to work in a team environment; keep neat and accurate records, willing to work in outdoor areas as well as a sterile environment, follow OSHA, FDA and other regulatory guidelines and assist in other duties and areas of maintenance as needed. Requirements: • Be familiar with all Certification test equipment and their proper use, • perform airflow readings and be proficient in the analysis of obtained data, • travel to customer sites to conduct HEPA filter testing and installations, • troubleshoot and diagnose problems in field testing situations, • prepare complete and organized reports, • routinely inspect HEPA filtered areas, • conduct periodic customer evaluation and service status on field HEPA filtered equipment, • communicate with client on their projects, • provide daily timesheets to certification coordinator, • have valid driver's license, • be able to pass an MVR

Job Description Unit Pack is a family-owned and operated company with over 50 years of experience in packaging liquids, creams, gels, serums, oils, and pastes in single-use packages catering to your packaging needs. Our packaging solutions include customized designs, classic sachets, and affordable and high-quality pouches showcasing your brand. At our Certified Organic and FDA-registered facility, we maintain rapid changeover ability and consistent on-time delivery, ensuring that your needs are always met. Our long-standing partnerships in cosmetics, pharmaceuticals, and industrial industries have made us a trusted name in the business for over three generations. Job Summary: As a Machine Operator, you will be responsible for operating and maintaining the machines to ensure efficient production of high-quality goods. Your primary focus will be on inspecting packages, monitoring machine performance, and maintaining a clean and organized workstation. Attention to detail, physical strength, and technical skills are essential for this role. Requirements: ● The job requires the ability to lift up to thirty pounds without assistance. ● You should be able to stand for prolonged periods of time. ● Climbing tall equipment to replace parts is a frequent task, so it is essential to do so safely. ● You will be working in a loud production floor environment, and proper hearing protection is mandatory. ● You must have a keen eye for detail to continuously inspect and focus on small details of produced goods. ● Inspect 100% of packages during production, including checks on print quality, seams, welds, and fill volume. ● Maintain the correct position at all times while operating the machine. ● Keep the workstation clean and organized, properly arranging tool trays, scale tables, and roll tables. ● Keep the work station stocked with necessary supplies: alcohol, wipes, gloves… ● Assemble boxes and fill them with the correct number of packages while adhering to designated weight requirements. ● Replenish raw materials on printers and tube makers, while also disposing if waste properly ● Replace wear parts to maintain a high level of quality in production ● Line boxes with paper to check for leaks and perform leak tests on boxes containing paper. ● Clean the production line at required times following work instructions to prevent downtime, interruptions, and defective packages ● Identify and replace defective jaws on the machine. ● Empty the butt trim chip bucket and water collect bucket at the machine as needed. ● Perform visual inspection to ensure proper functioning of pumps and prevent air entrapment unless the order is complete. ● Clean pumps following standard operating procedures (SOPs) for pump cleaning at designated cleaning stations. ● Accurately complete all quality control paperwork, following instructions and performing necessary checks. ● Report any issues with paperwork to the quality control team promptly. ● Record all machine stoppages using the Down Time Log, communicating with mechanics to accurately document stations and actions performed. ● Complete all tasks outlined in the Machine Operators Work Instructions on a daily basis. ● Attend weekly Machine Operator meetings to stay updated on any changes or improvements. ● By diligently executing these responsibilities, you will contribute to the overall efficiency and productivity of the production process and ensure the delivery of high-quality goods to customers. *Please note that this job description is subject to change as needed based on the evolving requirements of the role and the production environment. Company DescriptionUnit Pack is a family-owned and operated company with over 60 years of experience in packaging liquids, creams, gels, serums, oils, and greases in single-use packages. Our packaging solutions include customized designs, classic sachets, and affordable and high-quality pouches showcasing brands. At our Certified Organic and FDA-registered facility, we maintain rapid changeover ability and consistent on-time delivery, ensuring that customer needs are always met. Our long-standing partnerships in cosmetics, pharmaceuticals, and industrial industries have made us a trusted name in the business for over three generations.Unit Pack is a family-owned and operated company with over 60 years of experience in packaging liquids, creams, gels, serums, oils, and greases in single-use packages. Our packaging solutions include customized designs, classic sachets, and affordable and high-quality pouches showcasing brands.\r\n\r\nAt our Certified Organic and FDA-registered facility, we maintain rapid changeover ability and consistent on-time delivery, ensuring that customer needs are always met. Our long-standing partnerships in cosmetics, pharmaceuticals, and industrial industries have made us a trusted name in the business for over three generations.

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

POSITION SUMMARY: Analytical Chemist will be engaged in the different laboratory testing using a range of analytical equipment and techniques within GMP laboratory. MAJOR DUTIES/RESPONSIBILITIES: • Perform assigned testing including but not limited to the physical, chemical tests per in-house written procedures and compendial monograph for the raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemistry, physical and instrumental techniques such as LC, GC, UV-Vis Spectrophotometer, dissolution, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments., • Document work clearly and perform tests accurately. Record data and results as specified in documentation procedures., • Maintain proper laboratory logbooks, notebooks and other records all the time. Report and participate in the deviations and investigations. · Perform laboratory related other duties as assigned. MINIMUM/PREFERRED REQUIREMENTS: Education: Bachelor’s Degree in Science/Chemistry Experience: Based on the position level, must require minimum 2-10 years prior experience working in the Quality Control Laboratory in a cGMP environment, preferably in pharmaceutical industry. Hands on Empower-3 experience is plus. QC experience in Generic Pharmaceutical industries would be preferable Knowledge in Good Documentation practices. Knowledge in USP/ FDA BENEFITS: Offers a comprehensive benefits package to employees

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

Quality Assurance Specialist - for Leading Food & Beverage Manufacturer • Jersey City, NJ Area, • Quality Assurance Specialist Are you a detail-driven, proactive professional passionate about food safety and quality excellence? Join a dynamic, fast-paced team at a leading food manufacturing facility where innovation, integrity, and continuous improvement are at the heart of everything we do. We are seeking a Quality Assurance Specialist who thrives in a collaborative environment and is committed to upholding the highest standards of product quality, regulatory compliance, and operational efficiency. Key Responsibilities: • Champion quality assurance initiatives across manufacturing and support facilities., • Lead and optimize quality control processes to ensure product safety and consistency., • Conduct inspections, audits, and testing aligned with FDA, USDA, and internal standards., • Drive compliance with food safety regulations including HACCP, SQF, and GMP protocols., • Analyze quality data, identify trends, and implement corrective/preventive actions., • Collaborate cross-functionally to enhance quality systems and continuous improvement efforts., • Develop and deliver training programs on QA procedures and food safety standards., • Manage vendor relationships and coordinate external support when needed., • Monitor regulatory changes and assess operational impact. Qualifications & Skills: • Bachelor's Degree preferred (Food Science, Microbiology, or related field)., • HACCP, SQF, or equivalent certification highly desirable., • 2-5 years of hands-on experience in QA within the food and beverage sector., • Strong knowledge of FDA, USDA, and state/local regulatory frameworks., • Proficiency in Microsoft Office and QA software tools., • Exceptional analytical, organizational, and communication skills., • Bilingual in English and Spanish is a strong plus.

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

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 DescriptionPharmacist-in-Charge (PIC) – Supervising Pharmacist About PersonalRx 🌐 PersonalRx is a patient-first, service-driven pharmacy dedicated to improving lives through personalized medication management and reliable home delivery. By combining technology, clinical expertise, and regulatory excellence, we ensure every prescription is filled accurately and on time. Join our growing team and help shape the future of pharmacy care. Position Overview PersonalRx is seeking an experienced and motivated Pharmacist-in-Charge (PIC) / Supervising Pharmacist to lead our East Rutherford, New Jersey pharmacy operations. This role carries full accountability for regulatory compliance, pharmacy operations, and team performance while maintaining a strong focus on patient-centered care. The ideal candidate brings deep pharmacy operations experience, strong leadership skills, and a proactive approach to quality, compliance, and continuous improvement. Key Responsibilities * Serve as the designated Pharmacist-in-Charge (PIC) with full accountability for pharmacy operations * Ensure compliance with all New Jersey Board of Pharmacy, state, and federal regulations, including DEA, Medicare, and Medicaid requirements * Lead, mentor, and support a team of 5–10 pharmacists and pharmacy technicians * Partner with the Operations Manager to streamline workflows, improve productivity, and maintain exceptional service levels * Collaborate with executive leadership on strategic initiatives, service expansion, and operational improvements * Manage pharmacy inventory, including procurement, storage, and controlled substance accountability * Oversee quality assurance programs, audit readiness, and continuous process improvement initiatives * Serve as the primary contact for regulatory inspections, audits, and third-party payer reviews * Evaluate, implement, and oversee pharmacy technology systems; ensure staff training and compliance * Resolve escalated patient issues while maintaining a high standard of patient-centered care Qualifications * Doctor of Pharmacy (PharmD) or equivalent degree from an accredited institution * Active, unrestricted New Jersey pharmacist license (required) * Minimum 5–7 years of pharmacy operations experience, including 2+ years in a PIC or leadership role * Strong knowledge of USP, DEA, FDA, and NJ State Board of Pharmacy regulations * Proven experience managing teams and workflows in a complex pharmacy environment * Proficiency with pharmacy management systems and related software * Excellent communication, organizational, and leadership skills * Demonstrated commitment to patient safety, quality, and service excellence Preferred Qualifications * Experience in specialty, long-term care, or mail-order pharmacy * Familiarity with Medicare Part D and third-party payer processes * Strong analytical, reporting, and process-improvement skills Compensation & Benefits * Competitive salary: $150,000 – $160,000 (commensurate with experience) * Paid time off and paid holidays * 401(k) * Professional development support and continuing education reimbursement * Collaborative, mission-driven work culture Why Join PersonalRx? At PersonalRx, you’ll have the opportunity to make a meaningful impact every day—enhancing medication safety, improving patient outcomes, and leading a talented pharmacy team in a supportive, growth-oriented environment. Apply today! A member of our leadership team will review your application promptly. Powered by JazzHR 8VbHc57Fyc

Job Description Clinical Research Nurse (per diem) Title: Clinical Research Nurse (per diem) Location: Secaucus, NJ (On-site required) Reports To: Executive Medical Director and Principal Investigator Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary: We are seeking a licensed and detail-oriented Clinical Research Nurse in support of clinical trials conducted at Frontage Clinical Services. in support of clinical trials conducted at Frontage Clinical Services. responsible for working under the guidance of the Investigators; Management, Study Coordinator and Supervisor, to perform study procedures required in clinical studies conducted on behalf of sponsors at the Frontage Clinical Services site in Secaucus. Responsibilities: • Assist Clinical Study Coordinators in any task as needed., • Administer Medications (including IV administration route) per doctor’s and protocol instructions., • Perform study procedures (e.g., venipunctures, obtain and process biological specimen samples, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Principal Investigator and Sub-Investigators, Director, Associate Director, and Clinical Research Coordinators., • Record study data in the source documents. Evaluate and review study data to ensure accuracy and completeness., • Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures., • Develops a strategy for implementing study procedures in compliance with the study protocol., • Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor., • Responsible for maintaining emergency medication in the crash cart., • Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator., • Assists in the screening of research subjects to evaluate their eligibility for a clinical study., • Creates and performs QC procedures., • Assists in the reconciliation of IPs and maintaining accountability., • Acts independently to determine methods and procedures on new assignments and may supervise the activities of other Clinical Services personnel (e.g., Laboratory and Medical Technicians/ Assistants, Administrative Assistants, and Recruiters.), • Bachelors in Science in Nursing., • Registered Nurse in the State of New Jersey, • Good communication skills with the ability to interact with the Principal Investigator, Sub-Investigators, and Frontage Clinical Services and sponsor personnel., • 1-3 years' experience in clinical research is desirable. Knowledge of FDA regulatory requirements is necessary, or mandatory on-job training will be required. Salary and Benefits: Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Job Description Our client in Fairfield, NJ is looking for a Senior Product Release Engineer for a Full time position. Pay is $110-125k annually DOE Responsibilities: • Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements., • Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs., • Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes., • Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities., • Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities., • Understand and meet Regulatory (FDA) requirements and processes for development., • Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s., • Bachelor’s degree in mechanical engineering or biomedical engineering., • Minimum of 10 years of medical device experience., • Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products., • Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact on company objectives.

Job Description Job Title: IT SAP Specialist – North America Department/Division: Information Technology/SAP Reports to: VP of Finance North America and Global Director, Head of Group SAP Applications & Systems About LTS: LTS Lohmann Therapy Systems is a premier, global Contract Development and Manufacturing Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems. From concept to market, launch to lifecycle management, we deliver single source oral and transdermal drug delivery solutions that power partners’ market advantage. Every one of our 1,500 plus members of the LTS family, across three continents, is focused on utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes. We Care. We Create. We Deliver. Job Summary We are seeking an IT SAP Specialist to join our global IT team with a focus on our North American locations. In this role, you will act as an in-house consultant. You will independently plan, organize, and execute SAP-related projects with a focus on production, supply chain, warehouse, and quality management. You’ll manage and optimize SAP modules (PP/PI, MM/WM, QM) and support FI and CO integration, ensuring compliance with global IT standards and regulatory requirements. This is a full time, hybrid role located in/near St. Paul MN or West Caldwell, NJ • Hybrid potential after initial probationally period, up to 2 days/week, • Travel between the MN and NJ sites is required. Occasional travel to Germany as well. * We do not offer relocation assistance for this role* What You’ll Do: • Lead SAP projects and enhancements for production and supply chain processes both MN and NJ sites., • Configure and customize SAP modules (PP, MM, WM, QM, PM)., • Analyze business processes and implement improvements., • Provide user training and support across North America-currently sites in MN and NJ., • Collaborate with global SAP teams on international rollout projects., • Ensure compliance with cGMP, FDA, and DEA standards. What We’re Looking For: • Education: Bachelor’s degree or equivalent experience in IT or related field., • Experience: Minimum 4–5 years in SAP with functional and technical expertise in PP/PI, MM/WM, QM., • SAP Skills:, • SAP configuration and customizing experience, • ABAP development knowledge- ability to read code, • Familiarity with FI and CO integration, • Experience with barcode technologies, • Strong communication, organizational, and problem-solving skills., • Experience working in a GMP regulated environment., • Project management experience helpful, • Experience with at least 1-2 full lifecycle SAP implementations. Ready to make an impact? Apply today and help us deliver the future of drug delivery systems. LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.