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QA-ready reporting Maintain detailed, compliant documentation in accordance with FDA cGMP requirements Support method development, verification, validation, and transfer activities Participate in investigations including deviations, OOS/OOT, and CAPA Maintain laboratory equipment including calibrati

Job DescriptionDescription: This position is located in Chantilly, Virginia (Washington DC Metro area) Relocation bonus and temporary accomodation is provided. Granules Pharmaceuticals Inc., (GPI) has worked towards strengthening our core for the past 40 years and is currently the 4th largest generic pharma company in the US for controlled substances! With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform. We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options. The Production Operator performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Applies skills and knowledge to recognize issues and to increase efficiency, throughput, and quality. Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Assists in troubleshooting process issues. Responsible for the safe and efficient execution of job duties. Hiring across all shifts: 1st, 2nd & 3rd shift 1st shift: 7:00a - 3:30p EST 2nd shift: 3:00p - 11:30p EST 3rd shift: 11:00a - 7:30a EST Must be able to train from 8:30am - 5:00pm EST for approximately 1 month Flexibility to work Overtime is Required English communication required Key Accountabilities: • Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, pellet coating, granulating, drying, milling, blending, compressing, Encapsulating, Coating, potent compound, etc. Meets the requirements for use of manufacturing equipment and other commonly used equipment per SOPs., • Executes written SOPs to ensure the purity of materials involved in the manufacturing process., • Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs., • Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production., • Cleans manufacturing equipment and facilities according to established SOPs., • Executes machine changeovers from batch to batch., • May sample batches for quality testing. Executes required in-process product quality checks and documents accurately., • Understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Documentation: • Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy., • Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets., • Verifies the manufacturing process on BPR in an accurate and timely manner., • Provides status updates and operational challenges on status boards. Continuous Improvement: • Assists in troubleshooting process issues; refers deviations from standard procedure to the supervisor., • Typically participates in at least one continuous improvement project of a moderate scope and complexity. Safety & Compliance: • Adheres to all cGMP compliance/regulatory mandates and quality requirements., • Participates in safety teams, start-up discussions, incident debriefing sessions, etc., • Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies., • Maintain a clean, organized, work area. Training: • Conforms to all training requirements, including company required and machine-specific training. Teamwork & Collaboration: • Contributes to team and project success by sharing previously acquired knowledge., • Collaborates typically within own cross-functional work unit and occasionally with contacts outside own unit or department.Requirements:, • Trainee - Level I Operator:, • HS diploma, GED or College associate degree, • Minimum of 1-3 years' experience in a labor-intensive environment, • Forklift certification preferred., • Ability to communicate and comprehend English language both verbally and written, • Level II Operator (OSD/Solid Dose Manufacturing experience required):, • HS diploma, GED or College associate degree, • Minimum of 3-7 years of OSD pharmaceutical manufacturing (cGMP) experience, • Forklift certification preferred., • Level III Operator (OSD/Solid Dose Manufacturing experience required):, • HS Diploma, GED or College associate degree, • Minimum 7+ years of pharmaceutical manufacturing (cGMP) experience and certification in assigned area, as required or proficiency demonstrated in competencies as required., • Forklift certification preferred. Required Knowledge & Skills for Level II & III • Strong background in solid dose manufacturing (OSD), • Experience in 1 or more of the following areas: Compression, Granulation, Encapsulation, Wurster Coating, Coating, Fluid Bed Dryers, Bead Tower, • Capable of cleaning, setting-up, dismantling and operating state of the art tablet presses and encapsulation, i.e., Fette 3200i; Fette P 3030; MG2 planeta; Korsch XM 12., • Knowledgeable of FDA regulations, GMP, Lean Manufacturing, Six-Sigma, etc., • Solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position., • Basic math, reading, legible writing skills, and problem-solving abilities., • Proficient in sampling batches, • Ability to participate in Continuous Improvement projects. Required for all levels: Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Physical Requirements: Must be able to stand for long periods of time (up to 12 hour shifts), maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes. We believe in fair and transparent pay practices. Actual compensation is determined based on relevant experience, qualifications, skills, and internal equity.

Job Description Job Description Date 10/2025 Location 22 Van Dyke Avenue, New Brunswick NJ 08901 / 1300 Airport Road, North Brunswick NJ 08902 Title Operator, Dispensing Department Dispensing Reports to Manager, Dispensing FLSA (Exempt or Non-Exempt) Non-Exempt Role Overview The Dispensing Operator will perform all functions related to dispensing of material, receipt of goods, put-away material into warehouse aisles, pull out material per Batch card/Pick ticket, put back to same location from where it was pulled for batches, manual order processing, order auditing, shipment preparation, pallet building, transferring material from wood to plastic pallets, and cycle counting inventory. All functions may require the use of powered industrial trucks, Syspro or RF as needed. Will need to work in temperature-controlled areas. Areas of Responsibility Level 1: Dispensing Operator Overview: This is a training-level role for individuals with limited or no prior experience in pharmaceutical dispensing. Works under close supervision while learning company SOPs, GMP standards, and equipment operations. Key Responsibilities: • Assist in pulling and weighing raw materials under supervision., • Learn to read and interpret batch cards and pick slips., • Calibrate scales before use., • Cleans room after batch is complete, • Ensures safety and quality standards are consistently followed., • Maintain basic cleanliness of work area and equipment., • Support warehouse duties such as material receipt and basic inventory handling., • Follow safety procedures and learn PPE protocols., • Operate pallet jacks or assist with forklift activities (if certified). Level 2: Dispensing Operator Overview: This level is for operators with hands-on experience in pharmaceutical or supplement dispensing. Operators are responsible for completing batch-related activities with minimal supervision and maintaining documentation compliance. Key Responsibilities: • Dispense raw materials independently per batch cards., • Reviews batch card. Determine material to be used in the batch. Pull out material per requirement and enter in logbooks., • Performs requests received from other departments such as R&D, Production, QA or Purchasing etc., • Cleans room after batch is complete, • Ensures safety and quality standards are consistently followed., • Weigh materials accurately and calibrate scales before use., • Use Syspro or RF systems for inventory control., • Handle, put-away, return, and transfer of goods between warehouse locations., • Perform manual order processing, auditing, and preparation for shipments., • Maintain gowning and hygiene protocols in controlled environments., • Ensure accurate documentation in logs and batch records. Level 3: Dispensing Operator Overview: A highly experienced operator who may act as a team lead or trainer. Oversees batch dispensing activities, ensures compliance, and supports continuous improvement initiatives. Key Responsibilities: • Lead batch dispensing operations; verify materials and documentation., • Train and mentor entry and intermediate-level operators., • Collaborate with cross-functional teams (QA, R&D, Production)., • Reviews batch card. Determine material to be used in the batch. Pull out material per requirement and enter in logbooks., • Performs requests received from other departments such as R&D, Production, QA or Purchasing etc., • Cleans room after batch is complete, • Ensures safety and quality standards are consistently followed., • Conduct cycle counts and helps manage inventory accuracy., • Troubleshoot equipment or material issues; escalate when necessary., • Lead compliance audits for dispensing areas., • Support continuous improvement, safety, and 5S initiatives. Physical & Environmental Requirements (All Levels): • Able to lift 55 lbs regularly; occasionally up to 75 lbs., • Stand/walk for 6+ hours per shift., • Work in temperature-controlled rooms with PPE (lab coat, gloves, face mask, respirator, etc.)., • Exposure to dust, noise, and cleaning agents. Bottom of Form Requirements Education & Qualification: Level 1: Dispensing Operator • High school diploma or GED., • 0–1 year of experience in manufacturing or warehouse setting., • Basic math and English reading skills., • Willingness to learn cGMP, OSHA, and SOPs. Level 2: Dispensing Operator • High school diploma or GED., • 2+ years of experience in a pharmaceutical production environment., • Forklift operation experience (certification preferred)., • Familiarity with cGMP and SOP documentation standards., • Attention to detail and ability to troubleshoot basic dispensing issues. Level 3: Dispensing Operator Requirements: • High school diploma or GED; technical certification a plus., • 4+ years of dispensing experience in a GMP-regulated and within a pharmaceutical production environment, • Strong understanding of regulatory compliance (FDA, GMP, OSHA)., • Proven ability to lead teams and communicate effectively., • Proficient in inventory software (Syspro or similar ERP systems)., • Additional experience in granulation, compression, or blending is a strong plus. Certifications, Licenses, Credentials: • Prior certification to operate a sit-down forklift is a plus. Skills & Ability • Demonstrates ability to work in a team and assist others., • Able to follow written instructions precisely and perform basic math calculations as required., • Understands and is knowledgeable of cGMP, OSHA standards, etc., • Mechanically inclined to understand the inner workings of the equipment., • Demonstrates the ability to read and write basic English to be able to understand the industry-regulated instruction sheets., • Must have attention to detail. Physical Requirements (lifting, etc.): • Ability to lift up to 55 lbs.; occasionally lift and move up to 75 pounds., • Must stand and walk on the production floor for a minimum of 6 hours per shift, • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances., • Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment., • Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment 1st shift - 7:00 AM to 3:15 PM

A career at Whole Foods Market is more than just the work you do- it's about your personal growth and creating meaningful change. Our purpose is to nourish people and the planet. That means improving how people eat, funding grants for school gardens, providing access to fresh and healthy food to people living within food deserts, alleviating poverty in developing countries, and so much more. Working with us means you are making a difference within your community and beyond. We aren't just a grocery store: we're world-changers. And with your help, we will continue to set the standards of excellence and revolutionize the grocery industry. Assists with the scheduling and supervision of Team Members as well as with the day-to-day flow of the department. Oversees and maintains compelling Prepared Foods, coffee, and juice displays. Supports the Prepared Foods Team Leader and Associate Team Leader(s) to ensure smooth operation of the Prepared Foods Team. All Whole Foods Market Retail jobs require ensuring a positive company image by providing courteous, friendly, and efficient service to customers and Team Members at all times. All positions must be performed in accordance with team and store Standard Operating Procedures. Further, Team Members must be prepared and able to perform the duties inherent in other Team Member job descriptions. All positions must strive to support WFM core values and goals, promote national, regional, and store programs and initiatives, and ensure adherence to all applicable health and safety regulations including Food Safety and regulatory duties required in the department. • Supervises and delegates tasks to Prepared Foods Team Members., • Works with Prepared Foods Trainer to train Team Members in a manner that builds and sustains a high-performance team and minimizes turnover., • Assists in training of new Team Members, utilizing learning checklists and training materials., • Keeps all cases and shelves clean, well-stocked and properly rotated., • Opens and closes department according to established procedures., • Ensures all necessary breaks are given., • Communicates team concerns to the Team Leader and Associate Team Leader., • Sets and achieves the highest standards of retail execution., • Fosters and encourages a positive environment of outstanding teamwork, mutual respect, and exceptional morale., • Maintains awareness of customer flows and needs and directs Team Members as necessary to satisfy and delight customers; responds promptly to customer needs and questions., • Selects, trains, develops, mentors, motivates, and counsels Team Members in a manner that sustains a high-performance team and minimizes turnover., • Provides timely, thorough, and thoughtful performance evaluations., • Consistently communicates and models WFM vision and goals., • Extensive knowledge of Prepared Foods team procedures and policies., • Strong demonstrated organizational and time management skills., • Excellent interpersonal, motivational, team building, and customer relationship skills., • Capable of teaching others in a positive and constructive manner., • Product knowledge., • Advanced knowledge of regulatory and safety policies and procedures., • Proficient mathematical skills for assessing financial performance, monitoring profitability, and managing inventory., • Demonstrated decision-making ability, leadership skills, and ability to prioritize and delegate., • Proficiency with email, Microsoft Office, and operations-related applications., • 12+ months retail experience., • Must be able to lift 50 pounds., • In an 8-hour work day: standing/walking 6-8 hours., • Hand use: single grasping, fine manipulation, pushing and pulling., • Work requires the following motions: bending, twisting, squatting and reaching., • Exposure to FDA approved cleaning chemicals., • Exposure to temperatures: <32 degrees Fahrenheit (freezing), 32-40 degrees Fahrenheit (refrigerators), >90 degrees Fahrenheit., • Ability to work in wet and dry conditions., • Ability to work a flexible schedule including nights, weekends, and holidays as needed., • Ability to use tools and equipment, including knives, box cutters, electric pallet jacks, and other heavy machinery., • May require use of ladders. Note: The purpose of this document is to provide a general summary of essential responsibilities for the position and is not meant as an exhaustive list. This document does not reflect all job duties or requirements for every position. Requirements build as one progresses through the job levels, so any job duties required at a lower level may be required at the higher level in addition to the duties listed for that higher level. Duties, assignments, and other responsibilities may differ for similar positions based on business conditions, departmental or geographic location, and/or needs for the particular position. An individual must demonstrate successful performance in their current position before being considered for promotion. In addition, in order to promote into a higher-level position, a business need for the promotion must exist and the candidate must be considered the most qualified person for the new position. Completion of certain milestones such as obtaining an advanced degree or certification, time in current position, or developing skills to perform at the higher-level role do not guarantee a promotion. The wage range for this position is $17.50-$30.20 Hourly, commensurate with experience. Whole Foods Market offers "Whole Benefits". Whole Benefits may include health insurance, retirement plan benefits, eligibility for a store discount, paid time off and access to other benefit programs. Eligibility for Whole Benefits is determined under the terms of the applicable Whole Benefits plan at a person’s date of hire. For additional information, visit our Whole Foods Market Careers site: https://careers.wholefoodsmarket.com/benefits. At Whole Foods Market, we provide a fair and equal employment opportunity for all Team Members and candidates regardless of race, color, religion, national origin, gender, pregnancy, sexual orientation, gender identity/expression, age, marital status, disability, or any other legally protected characteristic. Whole Foods Market hires and promotes individuals solely based on qualifications for the position to be filled and business needs. Whole Foods Market works with job sites like Indeed, LinkedIn, and ZipRecruiter to promote opportunities at our company. Please be aware that other career sites may not be accurate or up to date and may even be fraudulent. We encourage and recommend all candidates to apply via our site.

Job DescriptionJob Title: Packaging Technician - 2nd Shift Location: Monmouth Junction, New Jersey Type: Contract to Hire Compensation: $17-$19/Hour +$1.50 shift differential Contractor Work Model: Onsite Hours: Mon-Thu, 3pm - 1am Position Summary We are seeking a Packaging Technician (2nd Shift) to support the packaging of pharmaceutical products in a cGMP-regulated environment. This role involves operating packaging equipment, ensuring compliance with batch records and FDA guidelines, and maintaining accurate documentation. The position offers a contract-to-hire opportunity with growth potential based on performance and business needs. Duties and Responsibilities: • Operate and monitor packaging equipment (fillers, cappers, labelers, cartoners, shrink wrappers, etc.) to ensure efficient production., • Assist with equipment set-up, changeovers, and test runs for various products and batch sizes., • Accurately complete and maintain batch records and other required documentation., • Follow SOPs, cGMPs, FDA standards, and safety procedures at all times., • Collaborate with production staff to meet quality and production goals., • Perform general housekeeping and safety compliance within the packaging area. Qualifications:, • High school diploma or equivalent required., • Previous pharma packaging experience in a manufacturing environment strongly preferred., • Ability to read, interpret, and follow work instructions and safety procedures., • Strong attention to detail and record-keeping skills., • Effective verbal and written communication skills in English., • Ability to lift up to 50 lbs., stand for extended periods, and use Personal Protective Equipment (PPE). System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Ref: #562-Joule Staffing - Edison

Description: Job Summary The Senior Environmental Health & Safety (EHS) Manager is a full-time, exempt position at Kashiv BioSciences, LLC, responsible for leading and overseeing comprehensive EHS programs across two sites in New Jersey and Chicago. This role drives the development, implementation, and continuous improvement of initiatives that promote a safe and compliant work environment within a fast-paced biopharmaceutical production setting. The ideal candidate will ensure adherence to all applicable regulatory requirements while fostering a strong safety culture and proactively identifying opportunities to enhance workplace health and safety performance. Essential Duties & Responsibilities • Lead site safety programs and initiatives to promote a proactive safety culture and reduce workplace incidents, • Develop, implement, and maintain EHS policies, procedures, and training programs, • Conduct safety audits and hazard assessments within a manufacturing environment, • Ensure compliance with OSHA and other applicable regulatory requirements, • Lead incident and near-miss investigations and oversee corrective action implementation, • Track safety performance metrics and support continuous improvement initiatives, • Partner with operations leadership and HR on workers’ compensation and return-to-work processes, • Maintain required safety documentation and reporting, • Collaborate cross-functionally with operations, maintenance, and leadership to drive safety improvements and organizational change, • Employs EHS technical theories to solve practical problems., • Executes multiple, well defined EHS projects/assignments efficiently and documents the results expeditiously., • Becomes familiar with site processes, equipment, and EHS programs and works cross-functionally to complete EHS project work., • Support and maintain environmental and safety programs., • Oversees third party vendors while on site., • Applies established EHS standards and methods to identify, evaluate and control safety, health and environmental hazards present in the work operations and environment., • Evaluates operations to determine compliance with Kashiv BioSciences and governmental EHS standards and regulations., • Performs research and provides information on EHS matters., • Assists with developing and delivering EHS training and communications to persons internal to Kashiv BioSciences., • Assists with EHS program tasks and activities, including industrial hygiene, biosafety, ergonomics, process safety, environmental compliance, EHS inspections, fire protection, loss control, hazardous waste management and assistance with EHS committees., • Identifying latest innovations in EHS risk assessment and reduction, engineering design, operations, and pollution prevention or compliance strategies and making others aware of their potential application to assigned projects. Develop EHS strategies that identify and resolve potential EHS compliance problems before occurrence. Assist in resolving operational failures and inefficiencies that may manifest themselves as EHS deficiencies. Troubleshooting and solving problems relating to site operations systems and equipment., • Organizes daily activities, including technical components, to ensure timely completion of projects/assignments. Documents all work. Performs/supports planning of small EHS projects and interim goals for project completion and assists operational areas in plans to reach EHS compliance objectives. Participates in shutdown planning and scheduling, decontamination and decommissioning., • Works closely with site management and internal customers to assure compliance of ESH issues, equipment and documentation., • Complies with all company policies and standards. Requirements: Position Requirements and Qualifications Education: • Bachelor’s Degree in Safety, Environmental Health, Industrial Hygiene, or a related field (or equivalent experience) Experience: • 10+ years of EHS experience within a manufacturing environment in Pharma/Biopharma, • Strong knowledge of OSHA regulations and safety compliance programs, • OSHA industry training, • Experience leading safety training, audits, and incident investigations, • Experience working in regulated manufacturing environments (such as FDA or cGMP-regulated industries) preferred, • Experience supporting fast-paced production environments utilizing automated equipment or packaging systems preferred, • Ability to work cross-functionally and influence safety initiatives across departments, • Strong communication and collaboration skills with the ability to act as a change agent within operations, • Hazardous shipping guidelines, • Knowledge of MSDS, • Direct experience with regulated environments (e.g., cGMP, OSHA, EPA) preferred., • Experience of working in a highly regulated environment would be a significant advantage. Ideal characteristics: • Remains calm under pressure, displaying a positive, solution driven approach., • Displays key leadership skills, being visible, approachable, and accountable., • Understands Kashiv’s commitments and delivers with passion and urgency., • Act with honesty, integrity and respect for people and goals., • Can prioritize activities and own workload, ensuring vital tasks are recognized and acted upon. Special Skills: • Has Subject Matter Expertise in relevant EHS regulations, principles, pollution control technology, industrial hygiene and safety-related equipment & safeguards. Has basic technical knowledge and works on practical, worker health, safety and environmental problems., • Can effectively interact with team members. Can articulate the issues and solutions to teams upon which participates., • Can identify EHS technical problems, analyze effectively and solve in consultation with supervisor. Learns to develop investigation and problem-solving skills using standard safety engineering and technology techniques., • Can develop, analyze and interpret data., • Can collaborate with others to determine areas of potential risk to business success and generate gap analysis., • Skill to document technical assignments expeditiously., • Capable to work on multiple small projects simultaneously and meet deadlines., • Self-starter to manage workload and meet deadlines set by upper management. Gathers experience in planning work product deliverables to team projects to assure projects stays on track., • Learns application of basic safety engineering and science skills in product or process evaluation under supervisor., • Ability to work with contractors and provide support to others who review/approve and manage external EHS services in meeting business initiatives., • Maintains gowning certification for clean room activities. Environmental Health and Safety - Senior Manager - Base Salary Range and Yearly Bonus - $160,000 to $180,000 (dependent on years of experience and fit for the position) with up to a 10% yearly (discretionary) cash bonus Benefits/Perks: • Medical Insurance - Aetna, • Prescription Drug Converge | Rx, • Virtual Visits - Aetna/Teladoc, • Health Savings Accounts (HSA), • Flexible Spending Accounts (FSA), • Dental Insurance - Aetna, • Vision Insurance - VSP, • Life and AD&D Insurance, • Disability Benefits, • Supplemental Benefits, • Legal Services, • ID Theft Protection, • Travel Assistance, • Value Added Benefits & Services, • Health Advocate, • Life Assistance Program (LAP), • Student Loan Assistance Program, • 401K, • Monthly Cell Phone Allowance Work Environment & Physical Demands: General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel will be involved. Supervisory Responsibility, if any: No This position description is not a complete list of all responsibilities, duties or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization. Compensation details: 160000-180000 Yearly Salary PI6121b2ba9a3d-37820-40298567

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

Job Description Position Description: Position SummaryThe QA Inspector I is responsible for supporting Quality Assurance activities by ensuring products are manufactured, packaged, and released in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, company Standard Operating Procedures (SOPs), and applicable quality standards. This role performs in-process inspections, material sampling, line clearance, documentation review, equipment verification, and quality monitoring throughout manufacturing and packaging operations.Essential Duties and ResponsibilitiesEnsure compliance with current Good Manufacturing Practices (cGMP), FDA regulations, company SOPs, and quality standards during all phases of manufacturing and packaging operations.Perform sampling of raw materials, packaging materials, in-process materials, finished products, microbiological samples, validation samples, stability samples, and controlled samples in accordance with approved procedures.Review incoming raw material and packaging material documentation for completeness, accuracy, and compliance with established procedures.Prepare, issue, and maintain receipt, quarantine, and release labels for raw materials and packaging components.Perform routine calibration verification of in-house balances and maintain calibration records.Conduct room clearance, equipment clearance, and manufacturing and packaging line clearance inspections prior to production activities.Perform in-process quality inspections during manufacturing and packaging operations according to batch manufacturing records (BMRs), batch packaging records (BPRs), and established procedures.Collect, prepare, label, and submit bulk and finished product samples for Quality Control testing and QA retain samples.Review manufacturing and packaging logbooks for completeness, accuracy, and compliance.Perform equipment swab sampling and cleanliness verification as required.Verify packaging labels, printed components, and packaging materials before production begins.Verify cleaning activities have been completed before manufacturing or packaging equipment is released for use.Conduct visual inspections of labeling components and prepare inspection documentation.Issue labeling components according to packaging orders and monitor label room activities for compliance.Review batch manufacturing and packaging documentation for completeness, proper signatures, data accuracy, reconciliations, yields, and compliance before authorizing progression to the next processing step.Maintain proper storage, issuance, periodic inspection, and destruction of retain samples in accordance with SOPs.Verify functionality and operational readiness of manufacturing and packaging equipment and associated controls during production.Utilize business systems and software including Microsoft Office, SYSPRO, Rite-Scan, QR Code systems, and other electronic applications to document and track quality activities.Promptly report quality issues, deviations, or non-conformances to QA management.Support internal audits, inspections, investigations, and continuous improvement initiatives as assigned.Perform other duties and responsibilities as assigned.Education & Experience:High school diploma or equivalent required; an Associate's degree in a scientific or technical field is preferred.1-2 years of experience in Quality Assurance, Quality Control, manufacturing, or another regulated industry; pharmaceutical or dietary supplement experience is preferred.Basic knowledge of current Good Manufacturing Practices (cGMP), FDA regulations, Good Documentation Practices (GDP), and quality systems.Strong attention to detail with the ability to accurately inspect materials, review documentation, identify discrepancies, and maintain accurate records.Proficient in Microsoft Office applications and able to learn and effectively use ERP and quality management systems such as SYSPRO, Rite-Scan, barcode/QR code systems, or similar software; strong communication, organizational, and teamwork skills.

Job Description Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset. The Complaint Specialist is responsible for receiving, documenting, investigating, and resolving product complaints in accordance with company policies, regulatory requirements, and industry standards. This role plays a critical part in ensuring compliance with applicable regulations, including the US FDA QMSR, ISO 13485, EU MDR, and other global requirements. The Complaint Specialist works cross- functionally with Quality, Regulatory, Engineering, and CMO's to ensure timely and thorough complaint resolution and continuous product improvement. Role Responsibility: · Ensures the processing of complaints in a timely manner by coordinating and prioritizing complaint investigations. · Communicates with health care providers (HCP), HCP staff and/or patient to acquire relevant complaint information. · Responsible for facilitating the complaints process by receiving, reviewing and entering product complaint information into the complaints database. · Participates in root cause investigations in collaboration with cross-functional teams, including Quality, Engineering, and CMO's. · Coordinates and facilitates meetings to discuss complaints, prepares meeting minutes, and follows up on action items. · Contributes to the development and improvement of complaint handling procedures, work instructions, and forms. · Escalates issues to management and supports CAPA activities when necessary. · Provides customer communication and follow-up regarding complaint resolution status, as appropriate. · Evaluates complaint information and determines appropriate regulatory reporting requirements. · Prepares and submits reports to US FDA and other regulatory agencies within required timeframes. · Responds to inquiries from customers, regulators, and others as needed. · Prepares and analyzes trend reports on a monthly, annual, and ad hoc basis. · Assists with Post-Market Surveillance (PMS) activities as needed. · Maintains confidentiality and integrity of complaint files and records. · Other duties as assigned Skills and Competencies: · Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately · Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills · Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals · Prioritization: Effectively prioritizes work to ensure timely completion of work within scope · Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope · Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self · Problem Solving & Problem Prevention: Learns and uses strong problem-solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention · Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility Qualifications (Education & Experience): • Bachelor's degree in technical, scientific, or business-related discipline preferred., • 3 years related work experience as a complaint handler in the medical device industry, performing all duties described above., • Knowledge of medical terms and Medical Device Reporting regulations, • Exceptional organizational skills and attention to detail., • Able to perform job function with minimal supervision and work independently, taking initiative to make independent decisions, where appropriate. Physical Demands (if any) as well as how much travel the job requires: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job: • Work safely and follow all OSHA regulations and company safety policies and procedures., • For all on-the-job injuries or accidents, must notify manager/supervisor immediately., • Ability to regularly sit or stand for extended periods of time. Other Disclosures Spectrum Vascular is an Equal Opportunity / Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. For certain roles at Spectrum Vascular, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. Consistent with Spectrum Vascular's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Job Description The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access” to cutting edge trials throughout the United States and Europe. We are seeking a Pharmacy Technician. The role will assure safe, efficient, and cost-effective preparation of chemotherapy, biologic therapy, and supportive care medications for administration to patients following all applicable regulations. Also, this role will work collaboratively with Site Leaders and Pharmacists to maintain adequate and cost-effective inventory of drugs and supplies. The hourly pay for this role is $25.00 - $ 31.00 . However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience. Work Schedule: Monday - Friday 7:30 a.m - 4 p.m Location: START New Jersey 629 Cranbury Rd. East Brunswick, NJ 08816 Essential Responsibilities: • Mix and label chemotherapy, biologic therapy and supportive care medications., • Perform proper procedures and documentation in inventory management systems during the fulfillment of the medication order., • Prepare parenteral dosage forms utilizing aseptic techniques in accordance with departmental policies, standards set forth in current USP, state & federal regulations and GCP guidelines for investigational medications., • Prepare and deliver medication ensuring proper storage location requirements are met based on the stability needs of the product., • Perform routine weekly inventory and quality assurance tasks, including checking extemporaneously manufactured medications, commercially available medications, I.V. solutions and equipment for expiration dates, recalls, or signs of deterioration., • Receive medication and supplies in accordance with inventory control and purchasing policies. Help to maintain all medication inventory levels within the predetermined stocking level, calling attention to needs for revision, or perpetual supply problems., • Interact with study monitors by providing drug accountability reports and temperature storage logs. Facilitate monitor verification of inventory, training and other GCP documentation., • Maintain and generate reports through the applicable computer programs. Required Education and Experience: • High School Diploma/GED., • At least 2 years of experience preparing chemotherapy and biologic therapies., • Current State registration as a pharmacy technician (CPhT). Best-in-Class Benefits and Perks We value the time, talent, and dedication our employees bring to START. Our commitment to your well-being and growth is reflected in a competitive compensation package—based on experience—along with comprehensive benefits designed to support you both personally and professionally: • 401(k) retirement savings plan with employer match, • Eligibility for an annual performance bonus, based on role and company results, • Generous paid time off and paid holidays, • Comprehensive medical, dental, and vision coverage and optional insurance options, • Company p‑aid life and disability insurance for added financial protection, • Employee Assistance Program (EAP) providing confidential, no ‑cost support for you and your family from day one, • Flexible FSA and HSA plans to support your financial wellness, • Commitment to a supportive environment that values balance, wellbeing, and flexibility, • We’re committed to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START, you’ll join a team that values continuous learning, professional growth, shared ideas, and a culture built on inclusivity and innovation. More About START START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators across its Network of clinical trial sites. Learn more at STARTresearch.com. Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online. We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Job Description Job Description Date 2026 Location 1200 Airport Road, North Brunswick NJ Title Senior Manager, R&D Department Research & Development Reports to VP, Research & Development FLSA (Exempt or Non-Exempt Exempt Role Overview The Senior Manager, R&D will lead multiple product development programs through the research, scale-up, and commercialization process while ensuring adherence to cGMPs, SOPs, FDA requirements, and customer expectations. This individual will provide technical and managerial leadership to the R&D team, oversee development priorities, manage complex projects, and partner closely with Production, Quality, Regulatory, Procurement, and Commercial teams. The Senior Manager, R&D will play a critical role in building and executing integrated development plans, improving department capabilities, mentoring team members, and supporting the company’s strategic growth and innovation initiatives. The duties and responsibilities described are not limited to those outlined and are not intended to be a comprehensive list of all activities, functions, or responsibilities required of the position. Additional duties and responsibilities may be assigned as required. This position requires travel for customer visits and trade shows, both within the United States and internationally, as needed to support business objectives. Areas of Responsibility Leadership & Strategy • Lead and manage the R&D function for new product development, reformulations, and line extensions., • Supervise, coach, and develop a team of formulation scientists, chemists, and R&D associates., • Establish department priorities, allocate resources, and ensure project timelines are achieved., • Collaborate with senior leadership to define product strategy, innovation pipeline, and technical direction., • Drive continuous improvement initiatives related to product development, manufacturing processes, and departmental efficiency., • Serve as the technical lead and subject matter expert for formulation and process development activities. Product Development & Commercialization • Oversee development and commercialization of nutraceutical products including capsules, tablets (monolayer, bilayer, trilayer), beadlets, powders, stick packs, and other specialty dosage forms., • Develop robust formulations and scalable manufacturing processes for dietary supplements and nutraceutical products., • Research and evaluate new ingredients, technologies, excipients, delivery systems, and product claims., • Lead feasibility assessments, prototype development, and technical evaluations for new business opportunities., • Design and direct laboratory experiments, pilot studies, and process optimization activities., • Recommend alternative ingredients and/or process improvements to enhance product quality, manufacturability, cost, and efficiency., • Scale up pre-exhibit and exhibit batches to commercial manufacturing and lead technology transfer from R&D to Production., • Coordinate manufacturing start-up activities and provide floor support during scale-up and initial production runs. Regulatory, Compliance & Documentation • Ensure all product development activities comply with applicable SOPs, FDA regulations, dietary supplement regulations, and Current Good Manufacturing Practices (cGMPs)., • Create, review, and approve SOPs, technical documents, formulas, specifications, validation protocols, and product development reports., • Review batch records, process characterization studies, validation reports, deviations, CAPAs, and investigation reports., • Prepare and review technical briefs, ingredient specifications, risk assessments, and customer-facing development summaries., • Support internal and external audits, customer visits, and regulatory inspections., • Maintain accurate and complete project documentation in accordance with company standards. Cross-Functional Collaboration • Partner closely with Production, Quality Assurance, Quality Control, Regulatory Affairs, Procurement, Supply Chain, Sales, and Marketing teams., • Present technical findings, risks, recommendations, and project status updates to cross-functional teams and leadership., • Identify and proactively communicate development risks, technical issues, and timeline impacts., • Work with vendors and suppliers to identify and qualify new raw materials and technologies., • Support business development and customer meetings by providing technical expertise and formulation recommendations. Additional Responsibilities • Monitor industry trends, emerging ingredients, formulation technologies, and competitive products., • Develop and manage project timelines, budgets, and department metrics., • Assist with annual planning, capital requests, and staffing needs for the R&D department., • Perform other duties and special projects as assigned. Other Responsibilities Including Safety: • Comply with all job-related safety and other training requirements. Requirements Education & Qualification: • Master’s degree in Pharmaceutical Sciences, Chemistry, Food Science, Chemical Engineering, or a related scientific discipline required., • OR a combination of education and experience equivalent to the above requirements., • 8–12+ years of progressive experience in product development, formulation, and commercialization within the nutraceutical, dietary supplement, pharmaceutical, or CDMO industry., • Minimum 3–5 years of leadership or people management experience., • Strong experience with tablets, capsules, powders, beadlets, and related dosage forms., • Proven experience in scaling products from laboratory through commercial manufacturing., • Experience working in a fast-paced contract manufacturing or CDMO environment strongly preferred. Certifications, Licenses, Credentials: • N/A Skills & Ability • Thorough understanding of cGMPs, FDA regulations, dietary supplement regulations, and product development processes., • Strong technical knowledge of formulation science, process development, scale-up, and manufacturing., • Excellent leadership, coaching, and project management skills., • Strong analytical and problem-solving abilities with the ability to interpret complex technical data., • Excellent written and verbal communication skills., • Ability to manage multiple projects simultaneously and meet aggressive timelines., • Strong organizational and cross-functional collaboration skills., • High level of ethics, integrity, professionalism, and confidentiality., • Proficient in Microsoft Office and ERP/document management systems.Able to maintain a professional and positive attitude., • Able to maintain confidentiality and possess a high level of ethics and integrity. Physical Requirements (lifting, etc.): • The employee is frequently required to sit (50%), stand, and walk (50%). Uses hands to finger, handle or feel writing tools and computer keyboard. May reach with hands and arms and infrequently may lift up to 30lbs. Use desk telephone/cell phone to talk and hear or converse with other employees. Work Environment (Office, Warehouse, temperature extremes, etc.): • Primarily located in an office environment where temperatures are controlled for heat and air conditioning. Occasionally walks through warehouse or manufacturing workplace and will be required to wear appropriate PPE for each work area including safety shoes, hair net, safety glasses, face mask, gloves, or disposable jumpsuit. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

Job Description Quality Auditor Location: Edison, NJ Pay: $18/hr Shift: 1st shift - 6:00am-2:45pm 2nd shift - 3:00pm-11:45pm Join Our Team at Staffing Synergies! We are looking for a detail-oriented Quality Auditor to join our team. In this role, you’ll play a key part in ensuring that our products meet the highest standards of quality, safety, and compliance. If you thrive in a fast-paced environment and take pride in precision, this is the opportunity for you! What You’ll Do: • Perform quality inspections on production lines to ensure compliance with FDA, cGMP, SOPs, and customer requirements., • Partner with Production and Quality Management to resolve quality issues in real time., • Conduct inspections, audits, and Acceptance Quality Limits (AQL) checks to verify product integrity., • Confirm and record date codes, lot numbers, expiration dates, and labeling accuracy., • Place non-conforming materials in quarantine and document all deviations., • Monitor batch records, validation protocols, and ensure proper documentation is completed. What We’re Looking For: • 5+ years of GMP/QA experience in a manufacturing environment (or equivalent relevant experience)., • Strong knowledge of FDA and cGMP regulations., • Excellent communication, problem-solving, and teamwork skills., • Ability to work independently, manage multiple tasks, and adapt to changing priorities., • High School Diploma or GED required., • Bilingual a plus! Physical Requirements: • Ability to stand for long periods (8+ hours)., • Able to lift up to 25 lbs occasionally., • Comfortable with bending, squatting, reaching, and repetitive hand/finger use. If you’re passionate about quality and want to make an impact, apply today!

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

Job DescriptionABOUT VITALIEF Vitalief is a consulting firm built exclusively for the research and clinical trial industry, providing innovative Consulting and Functional Service Provider (FSP) solutions to academic medical centers, health systems, sponsors, CROs, and site networks. By combining deep subject matter expertise with the experience of senior research practitioners, we help organizations accelerate study activation, optimize operations, improve financial performance, and build scalable workforce solutions that reduce costs, increase efficiency, and advance clinical breakthroughs for patients. POSITION SUMMARY Vitalief is seeking an experienced Clinical Research Study Manager to join our team as a full-time employee supporting interventional oncology clinical trials at a premier research center in Somerset, NJ. In this highly visible role, you will oversee the successful execution of Phase II–IV oncology clinical trials, spanning multiple oncology disease groups, including Breast, GI/GU, Head & Neck, and Lung cancers. The ideal candidate thrives in a fast-paced, high-volume clinical research environment and is passionate about advancing cancer research while ensuring operational excellence, regulatory compliance, and the successful delivery of complex clinical trials. WHY VITALIEF? • Meaningful Impact: Support innovative oncology research that advances treatment options and improves patient outcomes., • People-First Culture: Join a collaborative environment focused on professional growth, innovation, and teamwork., • Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability coverage, a 401(k) retirement plan, and comprehensive healthcare benefits., • Work Location: Four (4) days on site in Somerset, NJ and one (1) day on site in Hamilton, NJ per week., • Schedule: Monday through Friday, 8:00 AM – 4:30 PM., • Salary Range: $115,000 to $145,000 depending on experience. RESPONSIBILITIES • Lead daily oncology clinical research operations across two locations., • Oversee protocol implementation, study activation, enrollment, data collection, and research workflows., • Supervise, mentor, and develop a small clinical research team., • Support recruitment, onboarding, performance management, competency assessments, and professional development., • Ensure compliance with GCP, FDA regulations, OHRP, NIH, HIPAA, and IRB requirements., • Oversee regulatory submissions, documentation, record retention, and reporting of protocol deviations., • Develop corrective and preventive action plans to support continuous improvement., • Partner with investigators, research leadership, clinical teams, and institutional stakeholders to support research goals and priorities., • Participate in operational planning, resource management, and process improvement initiatives., • Lead meetings and multidisciplinary collaborations to enhance research performance and patient access to clinical trials. QUALIFICATIONS • Bachelor’s degree in Nursing, Health Sciences, Life Sciences, Public Health, or related field required; Master’s degree preferred., • Minimum of 3 years of oncology clinical research experience, including experience managing clinical trials., • Minimum of 1 to 2 years of supervisory or management experience within a clinical research environment., • Registered Nurse (RN) preferred., • Experience working in an academic medical center, cancer center, or large healthcare system preferred., • Knowledge of oncology clinical trial operations, protocol implementation, regulatory requirements, and research compliance standards, including GCP, FDA, OHRP, NIH, HIPAA, and IRB requirements., • Demonstrated ability to lead, mentor, and develop research teams in a complex clinical environment., • Strong project management, organizational, and time management skills with the ability to manage multiple priorities., • Experience with quality assurance activities, auditing, process improvement, and operational optimization., • Proficiency with Microsoft Office and clinical research systems, including CTMS, EDC platforms, and/or OnCore., • Excellent written, verbal, and interpersonal communication skills with the ability to collaborate effectively with physicians, research teams, and cross-functional stakeholders., • Strong critical thinking, problem-solving, decision-making, and relationship-building abilities. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. 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 xLfb5xbMhe

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

Job Description The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access” to cutting edge trials throughout the United States and Europe. We are seeking an Advanced Practice Provider. The Advanced Practice Provider (APP) – Early Phase Clinical Research Program supports protocol-compliant patient care and clinical trial execution for Phase I and other early-phase oncology studies. Functioning as a sub-investigator under the supervision of the Principal Investigator (PI), the APP extends clinical capacity, supports screening and study visits, and enhances care coordination while preserving core investigator responsibilities specific to early-phase research Work Schedule: Monday-Friday 8:00am-5:00pm Location: 629 Cranbury Rd. Suite 102 East Brunswick, New Jersey 08816 The annual base salary for this role is $170K-$195K. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience. Essential Responsibilities: • Serve as a sub-investigator on assigned early-phase clinical trials following completion of required training and delegation documentation., • Conduct protocol-required physical examinations and study visits for patients in screening, on treatment, and in follow-up as delegated by the Principal Investigator., • Prepare comprehensive medical histories and clinical summaries in advance of new patient consults to support efficient PI evaluation., • Assist with screening activities prior to new patient visits, including preliminary chart review and protocol feasibility assessment., • Support post-consent screening by assisting with protocol-specific screening questions and required clarifications., • Assist with the identification, documentation, and follow-up of adverse events (AEs) and serious adverse events (SAEs) in collaboration with the Principal Investigator and research team. Attend sponsor or safety calls designated as low priority or routine, as delegated by the Principal Investigator., • Act as the first point of clinical contact for the research care team for day-to-day patient management questions and escalate issues to the Principal Investigator as appropriate., • Coordinate with nursing, pharmacy, clinical research coordinators, and data management to ensure safe, efficient, and protocol-adherent care delivery. Required Education and Experience: • Advanced practice degree (Nurse Practitioner or Physician Assistant) with current licensure in the applicable state(s)., • Minimum of 5 years of experience in oncology clinical care or oncology clinical research. Preferred Education and Experience: • Master’s degree or Doctoral degree in advanced practice nursing or physician assistant studies., • National certification as a Nurse Practitioner or Physician Assistant. Eligibility and willingness to serve as a sub-investigator on oncology clinical trials., • Prior experience in early-phase (Phase I) oncology clinical research. Physical & Travel Requirements: • Travel: Limited travel may be required during training and onboarding. More About START START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators across its Network of clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world via our mission of “Hope Through Access”. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda – one of the most effective cancer drugs in medical history. Learn more at STARTresearch.com. Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online. We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Job DescriptionAbout Essenlix Corporation: Essenlix Corporation is a fast-growing medical device company focused on developing innovative point-of-care (POC) diagnostic systems, including hematology analyzers and disposable cartridges for complete blood count (CBC) testing. Our overseas manufacturing facility in China is ISO 13485 certified. We are strengthening our U.S. -based quality management system and integrating global operations as we transition from development to commercialization in preparation for FDA clearance and international market expansion. Position Summary: We are seeking an experienced Senior Regulatory Affairs Quality Systems Manager to lead FDA 510(k) and CLIA submissions and global quality system development. Key Responsibilities: Regulatory Affairs: • Lead preparation and submission of FDA 510(k) applications., • Coordinate CROs and external consultants., • Prepare DHF, risk management, clinical studies, labeling, and technical files., • Serve as primary contact with FDA. Quality Management System (QMS): • Lead remediation of U.S. QMS., • Ensure compliance with FDA QSR and ISO 13485., • Harmonize U.S. and China quality systems., • Manage document control, CAPA, training, and audits. Cross-Border Manufacturing: • Support ISO 13485-certified China facility., • Prepare sites for FDA inspections., • Manage quality agreements., • Support design transfer and validation. Cross-Functional Leadership: • Partner with RD, manufacturing, and operations., • Support design controls., • Provide regulatory guidance., • Train internal teams. Qualifications: Required: • Bachelor’s degree in related field., • 5+ years regulatory/quality experience., • FDA 510(k) and CLIA experience., • Knowledge of QSR, ISO 13485, ISO 14971., • CRO coordination experience. Preferred: • Hematology/CBC related product experience., • FDA foreign inspection experience., • QMS remediation experience., • Mandarin proficiency., • RAC certification. Compensation & Benefits: • Competitive salary., • 401(k)., • Health insurance., • PTO.

Job Description Position Description: Position Summary:The Procurement Buyer is responsible for managing the end-to-end procurement process for raw materials, excipients, packaging components, equipment, and services required for pharmaceutical manufacturing operations. This role combines transactional purchasing with strategic sourcing and supplier management to ensure uninterrupted supply, regulatory compliance, and cost efficiency. The Procurement Buyer works closely with cross-functional teams — including Planning, Quality Assurance, Regulatory Affairs, and Production — to support production schedules, new product launches, and continuous improvement initiatives.ESSENTIAL DUTIES AND RESPONSIBILITIES:•\tSource, negotiate, and purchase raw materials, excipients, packaging components, equipment, and services in compliance with cGMP, FDA, and company quality standards.•\tManage the full procurement cycle from request to purchase order issuance, delivery follow-up, and invoice reconciliation.•\tDevelop and maintain supplier relationships, evaluate performance, and implement improvement plans where necessary.•\tParticipate in supplier selection, qualification, and approval processes in collaboration with Quality and Regulatory teams.•\tLead price negotiations and contract discussions to secure competitive terms while ensuring quality and supply reliability.•\tMonitor and analyze market trends, lead times, and supplier capabilities to identify cost reduction and risk mitigation opportunities.•\tCollaborate with Production and Planning to forecast material requirements and ensure on-time availability while maintaining optimal inventory levels.•\tSupport new product development by sourcing new materials, packaging components, and technologies.•\tEnsure all procurement activities comply with internal SOPs, documentation standards, and regulatory requirements.•\tMaintain accurate procurement records, supplier documentation, certificates of analysis, and contracts in ERP or procurement systems.•\tContribute to continuous improvement initiatives aimed at enhancing procurement processes, supplier performance, and overall supply chain efficiency.QUALIFICATIONS AND DESIRED SKILLS: •\tBachelor’s degree in supply chain management, Business Administration, or a related field (or equivalent experience).•\t3+ years of procurement or purchasing experience, preferably in a pharmaceutical or GMP-regulated manufacturing environment.•\tStrong knowledge of cGMP, FDA, and other relevant regulatory requirements.•\tProven negotiation, communication, and supplier management skills.•\tProficiency with ERP or MRP systems and Microsoft Office Suite.•\tExcellent analytical skills with attention to detail and compliance.•\tAbility to work collaboratively with cross-functional teams and manage multiple priorities in a fast-paced environment.

Job Description Job Summary The Director, Healthcare Compliance is responsible for leading and operating the Company's healthcare compliance program and promoting a culture of ethics, integrity, and compliance across the organization. Reporting to the Chief Legal Officer & Chief Compliance Officer, this position serves as the Company's primary healthcare compliance leader and strategic advisor to Commercial, Medical Affairs, Market Access, Patient Services, Regulatory Affairs, and other business functions. The Director is responsible for designing, implementing, monitoring, and continuously improving an effective healthcare compliance program consistent with OIG Compliance Program Guidance, applicable federal and state healthcare laws, FDA regulations, industry codes, and Company policies. This is a highly visible, hands-on leadership role responsible for executing key aspects of the compliance program, including risk assessment, training, monitoring, investigations, transparency reporting, and compliance governance. The Director will partner closely with business leaders across the organization and may oversee compliance personnel and external resources as the function evolves. The Director will work closely with the Associate General Counsel on healthcare regulatory matters, investigations, policy development, compliance monitoring activities, and legal-compliance risk assessments. Core Responsibilities Program Leadership • Lead all aspects of the healthcare compliance program., • Develop and execute annual healthcare compliance strategy and work plan., • Conduct enterprise healthcare compliance risk assessments., • Maintain compliance policies, standards, procedures, and controls., • Develop compliance metrics and key performance indicators. Compliance Governance • Administer Healthcare Compliance Committee activities., • Prepare reports for Executive Leadership, Compliance Committee, and Board committees., • Escalate significant compliance risks and investigations., • Serve as the primary compliance advisor to the Chief Compliance Officer and provide regular updates regarding compliance program effectiveness, emerging risks, investigations, and remediation activities. Commercial and Medical Compliance • Serve as a core member of the MLR review process., • Advise on promotional materials and promotional claims., • Support launch and lifecycle compliance activities., • Provide guidance regarding speaker programs, advisory boards, consultants, grants, charitable contributions, sponsorships, and other healthcare professional engagement activities. HCP/HCO Interactions Provide oversight of: • Anti-Kickback Statute compliance, • False Claims Act risk mitigation, • Sunshine/Open Payments reporting, • State transparency laws, • Fair Market Value (FMV) assessments, • Needs assessments, • Engagement documentation and controls Monitoring and Auditing • Develop annual monitoring plan., • Conduct and oversee monitoring reviews., • Recommend and track corrective action plans., • Analyze trends and emerging compliance risks. Investigations • Lead healthcare compliance investigations., • Partner with Human Resources and Legal, when appropriate., • Ensure appropriate documentation, remediation, and CAPAs. Training and Communications • Create risk-based compliance training programs., • Deliver live training to commercial, medical, and cross-functional teams., • Maintain compliance communications and awareness initiatives. Compliance Leadership & Execution • Serve as a hands-on compliance leader responsible for both strategy development and program execution., • Personally conduct and oversee key compliance activities, including risk assessments, monitoring, investigations, training, and governance reporting., • Influence and lead cross-functional stakeholders without direct reporting authority., • Coordinate external advisors and consultants to support specialized compliance initiatives., • Build and scale the healthcare compliance function and team as business needs evolve. Qualifications • Bachelor's degree required., • JD, MBA, PharmD, MSN, or equivalent advanced degree preferred., • 10+ years of pharmaceutical, biotechnology, healthcare, or healthcare compliance experience., • 5+ years leading healthcare compliance programs, initiatives, or teams in a pharmaceutical, biotechnology, or healthcare organization., • Deep expertise in: o FDA promotional regulations o Anti-Kickback Statute o False Claims Act o Sunshine/Open Payments o OIG Compliance Program Guidance o PhRMA Code o State healthcare compliance requirements • Experience leading audits, investigations, training, monitoring, and compliance risk management programs., • Significant MLR review experience., • Demonstrated ability to independently build, implement, and operate healthcare compliance programs in a pharmaceutical, biotechnology, or healthcare environment., • Strong business partnering, communication, and influencing skills with demonstrated ability to engage effectively with executive leadership and cross-functional stakeholders., • Proven ability to manage multiple priorities in a dynamic growth environment. Reporting Relationship • Solid-Line Reporting: Chief Legal Officer & Chief Compliance Officer, • Dotted-Line Reporting: Vice President, Associate General Counsel, • Key Internal Partners: Legal, Commercial, Medical Affairs, Market Access, Regulatory Affairs, Finance, Human Resources, Quality, Patient Services, and Executive Leadership, • Direct Reports: None initially; future compliance personnel may be added as the compliance function evolves. Position Profile This role is designed to be the Company's senior healthcare compliance leader and primary compliance subject matter expert. The position combines strategic oversight with direct operational responsibility and requires a professional who can independently build, implement, monitor, and continuously improve an effective healthcare compliance program. Success in the role will depend on sound judgment, strong cross-functional influence, deep healthcare compliance expertise, and a willingness to operate as a hands-on leader while helping scale the compliance function as the organization grows. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Job Description Job Description Date 06/2020 Location 1200 Airport Road, North Brunswick NJ Title Chemist, Quality Control 1, 2 & 3 Department Quality Control Reports to Manager, Analytical, R&D, & Method Validation FLSA (Exempt or Non-Exempt Non- Exempt Role Overview The Chemist, QC role is responsible for performing analytical testing, laboratory investigations, data review, and quality control activities to ensure the identity, strength, purity, and quality of raw materials, active pharmaceutical ingredients (APIs), in-process materials, finished products, and stability samples. The role operates within an FDA-regulated laboratory environment and supports compliance with cGMP, Good Documentation Practices, company procedures, and applicable regulatory requirements. The Chemist performs chemical and physical analysis using a variety of analytical techniques and laboratory instrumentation, including HPLC/UPLC, GC, ICP-MS, UV-Visible Spectrophotometer, FTIR, Auto Titrators, Dissolution Apparatus, Karl Fischer Titrators, Bulk Density Testing, Potentiometers, and other QC laboratory equipment. The role is responsible for accurate testing, documentation, instrument operation, troubleshooting, and communication of analytical results to support product quality and timely release. Throughout all levels, the Chemist is expected to demonstrate strong analytical skills, attention to detail, problem-solving ability, and commitment to quality and compliance. The career progression moves from executing established laboratory procedures at the entry level to independently managing complex analytical challenges, supporting method validation/verification, compendial compliance, and providing technical leadership within the QC organization. Areas of Responsibility Chemist, QC 1: The Chemist, QC I is an entry-level laboratory professional responsible for performing routine chemical and physical analysis of raw materials, in-process samples, finished products, and stability samples according to established official and in-house test procedures. The Chemist evaluates samples for identity, strength, purity, and quality attributes while developing proficiency in analytical techniques, laboratory instrumentation, and GMP laboratory practices. The Chemist, QC I works under the guidance of experienced chemists and supervisors to ensure testing is performed accurately, safely, and in compliance with company procedures, cGMP, and regulatory requirements. Key Responsibilities • Perform routine sampling, chemical testing, physical testing, and assays of raw materials, active pharmaceutical ingredients (APIs), in-process materials, finished products, and stability samples in an FDA-regulated laboratory environment., • Perform analytical testing using wet chemistry techniques and laboratory instrumentation, including:, • HPLC/UPLC, • GC, • IR/FTIR, • UV-Visible Spectrophotometer, • Auto Titrator, • Dissolution Apparatus, • Karl Fischer (KF), • Potentiometer, • Bulk Density testing, • Prepare reagents, standards, solutions, and samples according to approved procedures., • Perform assigned testing activities and accurately document analytical results., • Support troubleshooting and testing of specific batches to assist with identification of potential causes of out-of-specification (OOS) results., • Assist with customer complaint investigations by providing analytical test results., • Prepare and review QC documentation, including test records, SOPs, test procedures, and protocols as assigned., • Perform routine instrument maintenance and calibration activities under supervision and training., • Maintain laboratory organization, housekeeping, safety, and chemical waste compliance., • Follow cGMP, Good Documentation Practices, and company quality requirements., • Complete approximately:, • 95% analytical testing activities, • 5% documentation and record review activities., • Work extended hours or occasional weekends as required., • Perform other duties as assigned. Chemist, QC 2: The Chemist, QC II is an experienced laboratory professional responsible for performing routine and complex analytical testing with increased independence. This role applies technical knowledge to troubleshoot analytical issues, support investigations, review data, maintain laboratory equipment, and provide technical support to QC operations. Chemist, QC II demonstrates proficiency with analytical instrumentation and applies knowledge of cGMP, and laboratory procedures to ensure accurate and timely testing. Key Responsibilities Includes all Chemist, QC I responsibilities, with increased ownership and accountability: • Independently perform chemical, physical, and instrumental testing of raw materials, APIs, in-process materials, finished products, and stability samples., • Perform complex analytical testing using QC instrumentation including:, • HPLC/UPLC, • GC, • IR/FTIR, • UV-Visible Spectrophotometer, • Dissolution, • Karl Fischer, • Auto Titrator, • Potentiometer, • Other QC laboratory equipment., • Troubleshoot analytical testing issues and instrument-related challenges., • Support investigations related to:, • Out-of-specification (OOS) results, • Atypical results, • Customer complaints, • Product quality concerns, • Analyze test results and provide technical input to assist with root cause determination and corrective actions., • Review analytical data and QC documentation for accuracy and completeness., • Prepare and revise SOPs, test procedures, protocols, and laboratory documentation., • Perform instrument maintenance, calibration, and troubleshooting activities with limited supervision., • Support continuous improvement activities within the QC laboratory., • Provide technical support and guidance to QC Chemist I personnel., • Ensure compliance with customer specifications, company requirements, and federal, state, and local regulations., • Maintain laboratory safety, compliance, and documentation standards., • Work extended hours or weekends as needed. Chemist, QC III : The Chemist, QC III is a senior-level technical contributor responsible for both routine and advanced analytical testing, complex troubleshooting, laboratory investigations, and technical leadership within the QC organization. This role serves as a subject matter expert for analytical methods, instrumentation, and laboratory practices while supporting compliance, continuous improvement, and cross-functional initiatives. Key Responsibilities Includes all Chemist, QC II responsibilities, with increased technical leadership: • Serve as a technical resource for analytical testing, instrumentation, and laboratory troubleshooting., • Perform and oversee complex analytical testing activities for raw materials, APIs, in-process materials, finished products, and stability samples., • Lead troubleshooting activities for specific batches and analytical issues to determine root cause and recommend corrective actions., • Lead or support complex investigations related to:, • OOS results, • Deviations, • Customer complaints, • Product quality issues., • Review and provide technical approval of analytical data and laboratory documentation., • Support analytical method validation, verification, transfer, and optimization activities., • Develop, review, and improve SOPs, test procedures, protocols, and technical reports., • Provide technical guidance and mentoring to QC Chemist I and QC Chemist II team members., • Support internal audits, customer audits, and regulatory inspections.

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. 2025, Eurofins generated total revenues of EUR € 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description The Senior FSE is considered a subject matter expert in the field of Calibrations, Preventative Maintenance and Repairs and the technical authority for the calibration and certification of clean rooms, biosafety cabinets and other controlled environments. They are expected to be CETA certified, write protocols, methods and SOP’s within their field of expertise, train and direct calibrations, qualifications, and certifications, and review and approve certification work carried out by other field service personnel. The role holds the professional credential on which the business's certification registration depends. The business will operate initially under CETA registration, and the role is accountable for building the operating record, testing hours and customer endorsements required to obtain NEBB Cleanroom Performance Testing firm certification, and for holding the NEBB certification personally on the firm's behalf. Certification Delivery • Perform and authenticate certification and requalification of cleanrooms and controlled environments, including:, • Airflow velocity and volume testing, unidirectional and non-unidirectional, • HEPA and ULPA filter installation leak testing by aerosol photometer or discrete particle counter scanning, • Room pressurization and pressure cascade verification, • Airflow visualization studies, including recording and interpretation, • Recovery testing and containment leak testing, • Non-viable airborne particle counting and ISO classification, including sample location determination, • Biosafety cabinet and fume hood certification to NSF/ANSI 49, • Isolator, RABS and glovebox testing, including glove integrity, • Author test methods, certification protocols and standard operating procedures for the service line, and maintain them through revision., • Review and approve certification reports produced by other engineers and technicians., • Investigate out-of-specification results and support customer deviation and corrective action processes, • Train and direct field service personnel carrying out clean room certifications, including technicians outside of the direct reporting line., • Establish and maintain the business's CETA registration, and deliver all certification work to CETA standards from appointment., • Build the record required for NEBB CPT firm certification — continuous operating history, annual cleanroom testing hours, instrument ownership, local chapter membership and endorsement letters — and manage the application., • Obtain NEBB CPT certification personally, completing the Technician examinations and subsequently the Certified Professional examinations, so that the business can authenticate NEBB Certified Reports., • Maintain relationships with customers and awarding authorities who may provide endorsement in support of firm certification., • Support the evaluation and, if pursued, the technical scope of ISO 17025 accreditation for physical certification. Team • Establish the training and qualification pathway for certification engineers and technicians within and outside the direct reporting line., • Train, mentor and assess engineers and technicians toward CETA and NEBB certification, and sign their competency records. Instruments • Specify, commission and maintain the certification instrument set, including particle counters, aerosol photometers and generators, balometers and flow hoods, thermal and vane anemometers, and micromanometers. Assist in the calibration of similar equipment used by other Eurofins businesses., • Perform troubleshooting, preventative maintenance and repair both in the field and in the lab of various types of laboratory equipment including balances, pH meters, environmental monitoring equipment, hoods, biosafety cabinets, room HEPA filters, plate readers and chambers., • Manage personal parts inventory effectively., • Provide feedback to Director regarding any issue impacting service delivery, particularly issues impacting turnaround times. Commercial and administrative • Provide the technical basis for quotations, including room counts, classification, test scope and frequency., • Represent the business technically to customers during scoping discussions and audits., • Complete administrative paperwork and reports promptly and accurately., • Follow good documentation practices (GDP) as applicable to daily activities., • Contact customers on time and schedule service efficiently., • Adhere to environmental health and safety guidelines., • Effectively communicate with clients and other internal and external parties., • Follow Eurofins work policies and all applicable SOPs. Ensure that training on both remains current., • Maintain client confidentiality, specifically if information about the customer is obtained from sources other than the customer (e.g. complainant, assessors)., • Act impartially within the management system., • Perform other tasks as assigned by Management. Qualifications Requirements • Four-year degree in a related field (e.g., chemistry, analytical chemistry, electronic engineering, or similar) plus 7-10 years’ experience in a related field, preferably as a Field Service Engineer., • SME on providing field service support for clean room certifications, hoods, biosafety cabinets, HEPA filters and other controlled environments., • CETA certification held and in good standing, obtained or renewed within the past five years — CNBT, RCP-CT, or equivalent CETA credential appropriate to the scope of work., • NEBB Cleanroom Performance Testing certification is an advantage, at either Certified Professional or Certified Technician level, held and in good standing. AABC certification will also be considered., • Clear, respectful, and timely verbal and written communication. Proven ability to author protocols, methods, qualification/validation documents and SOP’s., • Experience representing a certification firm during customer quality audits, state board of pharmacy inspections or FDA inspections is preferred., • Demonstrable knowledge of ISO 14644 Parts 1, 2 and 3, and ISO 14644-7 where isolators, RABS and gloveboxes are within scope., • NSF/ANSI 49 for biosafety cabinet and hood calibrations and certifications, • USP <797> and USP <800>, including state board of pharmacy certification and recertification requirements. Where this knowledge is not already held, it must be acquired within the first six months., • Physical ability to lift and transport equipment and perform tasks in various lab environments, • Experience with technical troubleshooting and problem solving, • Must be self-motivated and proactive, • Valid drivers license, • Clean driving record, • Ability to travel within customer territory up to 5 days per week Monday-Friday. Overnight travel as needed. Additional Information Position is full-time, Monday through Friday, 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of North Brunswick, NJ are encouraged to apply. Pay range: $100,000 - $130,000 annually depending on related experience and qualification. Excellent full time benefits including • Comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match, • Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labeling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. Job Description Supervise and assist in the conduct of regulatory studies performed. Responsibilities include: • Supervise study conduct., • Assist in protocol development, design and implementation., • Responsibilities as stated in GLP regulations., • Data interpretation and report writing., • Client liaison. Management Responsibilities: • Overall, day-to-day laboratory operation including supervision of technical staff assigned to your studies., • Scheduling and coordinating initiation and conduct of studies., • Ensure that the study schedule and financial aspects of each study that you are responsible for are accurately tracked on a regular basis. Technical Responsibilities: Overall responsibility for the technical conduct of all studies and interpretation, analysis, documentation and reporting of results. Specifically: • Establish test protocols and corresponding SOP's., • Develop experimental design and supervise implementation of experiments (tests)., • Obtain sponsor approval of protocols and institute any necessary deviations from the test protocol with sponsor approval., • Ensure all experimental data is properly recorded and that observations of unanticipated responses of the test system are accurately recorded and verified., • Ensure tests are conducted in accordance with the test protocol and SOP., • Supervise conduct of all phases of the study, including participation in study conduct., • Ensure that GLP regulations are followed., • Interpretation, calculation, analysis, documentation and reporting of results., • Instruct, train and supervise scientists in all procedures., • Maintain liaison with sponsors, advising them of test results; and assisting with protocol development., • Maintain liaison with regulatory agencies in conjunction with: test protocols, and past or present studies submitted for regulatory approval, compliance with GLP's and appropriate test guidelines., • Ability to safely wear a respirator requiredQualifications, • BS degree in a field related to their area of responsibility (e.g. animal science, chemistry, biology, microbiology)., • Minimum of 5 years experience overseeing biocompatibility studies, • Intimate working familiarity and/or ability to quickly learn and develop such familiarity with all government regulations dealing with testing particularly EPA, FDA, DOT, OECD, and GLP regulations in addition to ISO standards., • Hands-on working knowledge of the tests that will be under their responsibility., • Good administrative skills and leadership ability. Must communicate effectively and write well. Additional Information Position is full-time, Monday-Friday, 9:00am.- 5:00 pm, with overtime as needed. Candidates currently living within a commutable distance of Dayton, NJ are encouraged to apply. Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Job DescriptionABOUT VITALIEF Vitalief is a consulting firm built exclusively for the research and clinical trial industry, providing innovative Consulting and Functional Service Provider (FSP) solutions to academic medical centers, health systems, sponsors, CROs, and site networks. By combining deep subject matter expertise with the experience of senior research practitioners, we help organizations accelerate study activation, optimize operations, improve financial performance, and build scalable workforce solutions that reduce costs, increase efficiency, and advance clinical breakthroughs for patients. POSITION SUMMARY Vitalief is seeking an experienced Clinical Research Program Manager to join our team as a full-time employee supporting interventional oncology clinical trials at a premier research center in Somerset, NJ. In this highly visible role, you will oversee the successful execution of Phase II–IV oncology clinical trials, spanning multiple oncology disease groups, including Breast, GI/GU, Head & Neck, and Lung cancers. The ideal candidate thrives in a fast-paced, high-volume clinical research environment and is passionate about advancing cancer research while ensuring operational excellence, regulatory compliance, and the successful delivery of complex clinical trials. WHY VITALIEF? • Meaningful Impact: Support innovative oncology research that advances treatment options and improves patient outcomes., • People-First Culture: Join a collaborative environment focused on professional growth, innovation, and teamwork., • Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability coverage, a 401(k) retirement plan, and comprehensive healthcare benefits., • Work Location: Four (4) days on site in Somerset, NJ and one (1) day on site in Hamilton, NJ per week., • Schedule: Monday through Friday, 8:00 AM – 4:30 PM., • Salary Range: $115,000 to $145,000 depending on experience. RESPONSIBILITIES • Lead daily oncology clinical research operations across two locations., • Oversee protocol implementation, study activation, enrollment, data collection, and research workflows., • Supervise, mentor, and develop a small clinical research team., • Support recruitment, onboarding, performance management, competency assessments, and professional development., • Ensure compliance with GCP, FDA regulations, OHRP, NIH, HIPAA, and IRB requirements., • Oversee regulatory submissions, documentation, record retention, and reporting of protocol deviations., • Develop corrective and preventive action plans to support continuous improvement., • Partner with investigators, research leadership, clinical teams, and institutional stakeholders to support research goals and priorities., • Participate in operational planning, resource management, and process improvement initiatives., • Lead meetings and multidisciplinary collaborations to enhance research performance and patient access to clinical trials. QUALIFICATIONS • Bachelor’s degree in Nursing, Health Sciences, Life Sciences, Public Health, or related field required; Master’s degree preferred., • Minimum of 3 years of oncology clinical research experience, including experience managing clinical trials., • Minimum of 1 to 2 years of supervisory or management experience within a clinical research environment., • Registered Nurse (RN) preferred., • Experience working in an academic medical center, cancer center, or large healthcare system preferred., • Knowledge of oncology clinical trial operations, protocol implementation, regulatory requirements, and research compliance standards, including GCP, FDA, OHRP, NIH, HIPAA, and IRB requirements., • Demonstrated ability to lead, mentor, and develop research teams in a complex clinical environment., • Strong project management, organizational, and time management skills with the ability to manage multiple priorities., • Experience with quality assurance activities, auditing, process improvement, and operational optimization., • Proficiency with Microsoft Office and clinical research systems, including CTMS, EDC platforms, and/or OnCore., • Excellent written, verbal, and interpersonal communication skills with the ability to collaborate effectively with physicians, research teams, and cross-functional stakeholders., • Strong critical thinking, problem-solving, decision-making, and relationship-building abilities. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. 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 3NaVS1u2kO

Job Description Job Title: USA_Regulatory Associate - Level 3 Location: Warren, NJ Type: 12-month contract Compensation: $49.15 hourly Work Model: Hybrid – 2-3 days onsite Hours: 8am-5PM Overview: The purpose of this role is to execute OTC regulatory activities for new products registrations and life-cycle. Maintenance for the portfolio of products defined by the US Business Units. Responsibilities • Represent USRA on assigned projects, provide guidance on OTC drug regulatory pathways (monograph, NDA). • Develop regulatory strategies and documents for new product launches and maintenance of current products aligned with the regulations. • Develop regulatory label for OTC products, review claims and copy. • Participate in the review of promotional materials. • Support end-to-end regulatory compliance of products in remit. • Apply system and procedure updates to maintain up-to-date technical product records. • Identify and participate in process improvements within US Regulatory Affairs. • Interact with colleagues in other global functions to support global programs. • Effectively communicate regulatory technical requirements and guidelines, facilitating timely and complete submissions. • Develop up-to-date knowledge of guidelines and regulatory requirements, as well as technical trends. Requirements • Bachelor’s degree in Pharmaceutical or Life Sciences or equivalent regulatory experience. • 2-4 years’ experience in regulatory affairs including chemistry, manufacturing and controls, and OTC experience, preferably within a CPG/Consumer Healthcare/Pharma related industry. • Experience and knowledge in Quality, product development and manufacturing areas. • Experience working on FDA applications, OTC monograph products, chemistry, manufacturing and controls. • Proficient knowledge in US FDA regulations. • Excellent communication skills, stakeholder management, and ability to work in multidisciplinary teams. • Ability to manage and prioritize projects of high complexity. • Experience leading end-to-end regulatory processes in new product launches. • Additional Preferred Qualifications: knowledge of US regulatory framework for OTC drugs and devices, ensuring compliance standards, and regulatory lifecycle expertise. • Minimum 2 years of experience in regulatory affairs. • Competencies include agility, attention to detail, strong written and verbal communication skills, evidence-based decision making, and risk evaluation. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M- #LI- Ref: #568-Clinical

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

Job Description Job Summary The Regulatory Affairs Strategist is responsible for developing and executing regulatory strategies that support the approval and lifecycle management of pharmaceutical products. This role serves as a key liaison between the company and regulatory agencies, ensuring compliance with applicable regulations while facilitating timely submissions for clinical trials, marketing authorizations, and post-approval changes. Working cross-functionally with R&D, Clinical, Quality, CMC, and Commercial teams, the strategist provides regulatory guidance throughout all phases of product development. The ideal candidate will possess strong working knowledge of FDA regulations (including IND and NDA processes), international regulatory environments, and experience preparing regulatory documentation. This position requires strategic thinking, attention to detail, and the ability to navigate complex regulatory frameworks to support innovation and business goals. Job Responsibilities • Develop & implement regulatory strategies across product pipelines, including NDAs, BLAs, and supplements., • Draft and submit regulatory documents (e.g. INDs, NDAs, CTAs) to the FDA and international agencies (Canada, Europe, UK)., • Interpret and apply regulations (FDA, ICH, cGMP, USP standards) and monitor changes that may affect product development., • Provide regulatory guidance to cross-functional teams—R&D, clinical, CMC, quality, and commercial., • Maintain submission tracking systems, regulatory databases, and filings., • Interact with regulatory agencies, managing agency correspondence, meetings, and scientific advice requests., • Identify and mitigate regulatory risks, ensuring compliance and protecting timeline integrity., • Support global strategies, including alignment with non U.S. jurisdictions where applicable., • Lead and manage responses to Health Authority information requests., • Work with CROs, consultants, and the internal team as required to plan, manage, and support regulatory deliverables related to US and EX-US submissions for assigned projects., • Interface with senior management to provide project updates., • Anticipate regulatory risks and propose mitigation strategies., • Coordinate and prioritize assigned projects according to company goals. Qualifications • Advanced degree in a scientific discipline required (Life Sciences, PharmD, Regulatory Affairs, or related)., • RAC certification is a strong plus., • 5+ years of regulatory affairs experience—pharma, biotech, or medical devices., • Deep knowledge of FDA requirements and global regulations., • Track record in preparing and submitting regulatory filings., • Proficient in project management, communication, and negotiation., • Experience with submission platforms, eTMF, and regulatory databases., • Excels at cross-functional collaboration and facilitates effective communication and alignment across diverse teams., • Excellent oral and written communication skills., • Experience developing and implementing successful regulatory strategies., • The candidate should be detail oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This position has an expected base salary range of $140,000 - $160,000 annually

Job Description The CNC Programmer is responsible to analyze job orders, drawings, and blueprints to perform all the necessary calculations and programming to create products per customer specifications. The CNC Programmer is expected to: • Program, test, run and revise machine programming to meet customer specifications., • Set up machine with correct tooling to build product precisely and efficiently CNC Programming 50% · Writes programs from blueprints and/or solid models for the CNC machines with Swiss turning machine programming · Loads electronic files onto the machine. · Studies and interprets drawings, manuals, specifications or sample parts to determine dimensions and tolerances of finished work pieces, sequence of operations, and set-up requirements to maximize efficiencies. · Creates set-up sheets based on tooling selection criteria. · Monitors and verifies the accuracy of each job’s initial set-up and outcome. · Responsible for the machine performance and product outcome of assigned projects. · Revises programs and documents based on engineering changes. · Maintains library of programs. · Sets up and operates machine on a trial run to verify accuracy of machine settings or programmed control data. · Performs first piece inspection once setup is completed. Gives first piece to Quality Inspector and waits for Quality approval to continue. Quality Control 30% · Monitors machine operations to detect out of tolerance machining · Takes corrective action to bring units into specification. Red tags units that are out of specification (OOS), reports OOS to quality personnel and supervisor. · Coordinates with Quality department to ensure parts comply with specifications. · Communicates with supervisor, engineers, quality and other shop personnel for assignments and to resolve machine or quality issues. · Demonstrates ability to streamline processes to increase productivity and quality; production and prototype jobs are setup consistently, timely and accurately. Process Management 20% · Works for continuous process improvements and machine time reductions reporting program changes to Supervisor and /or Manufacturing Engineer. · Keeps CNC operators abreast of daily machine performance and project updates. · Assists in solving plant operating problems and/or cost reductions projects. This position has no talent management responsibilities. EDUCATION AND EXPERIENCE · Associate's degree or equivalent from two-year college or technical school in computer numerically controlled programming, machine tool programing, or a related field is required · 4-7 years of CNC programming experience is required. CNC programming experience in a manufacturing or production environment strongly preferred. · Proficient in writing programs from blueprints and/or solid models for the CNC swiss turning machines · 1-3 years of CAM programming experience is required. LICENSE AND CERTIFICATION · None TECHNICAL SKILLS · CAM programming · GD&T · G-code · AutoCAD Design software · ERP software · CNC equipment, 5-axis, Live tool lathe etc. · Citizen CNC and PartMaker · Blueprint reading · Measuring equipment o calipers o ID / OD micrometers o depth gauges o indicators · MS Office Suite OTHER SKILLS · Mechanical aptitude · Set-up, operation and programming of machines · ISO 13485 · FDA 21CFR820 While performing the duties of this Job, the employee is regularly required to sit; use hands to handle or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee is frequently required to stand; walk; and talk and hear. The employee must frequently lift, push, pull, carry and/or move to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts and vibration. The employee is frequently exposed to risk of electrical shock and odors, dusts, mists, fumes and/or airborne particles. . The employee is occasionally exposed to wet and/or humid conditions. The noise level in the work environment is usually loud.

Job Description Job Title: Packaging Mechanic I Location: Monmouth Junction, NJ Hours / Schedule: 2nd Shift | Mon–Thurs, 3:00 PM – 1:00 AM Type: Temp - Perm Compensation: up to $40 per hour (pending experience) Overview The Packaging Mechanic I supports the Packaging Department by maintaining and repairing packaging equipment. Responsibilities include troubleshooting, preventive maintenance, line changeovers / startups, equipment upgrades, and root cause analysis to ensure compliance with SOPs, cGMPs, and FDA requirements. Must have strong electronics / PLC (Programmable Logic Controllers) background with strong ability to troubleshoot and diagnose! Responsibilities Perform maintenance and troubleshooting on packaging equipment (fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc.) Conduct preventive maintenance, repairs, and continuous improvement activities Execute line changeovers and startups Support QA and Operations during packaging runs Ensure safe equipment operation at all times Requirements High school / GED Minimum 3 years of pharmaceutical / Biotech packaging mechanic experience Strong electrical background Hands-on experience with fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc. Must pass pre-employment and physical Proficient in manufacturing procedures, FDA regulations, cGMPs, SOPs Ability to read/interpreting safety, maintenance, and procedure manuals Basic PC skills Willingness to work overtime as needed Preferred Requirements Trade school or technical certification Physical Requirements Ability to lift up to 50lb Stand for extended periods Use of PPE as required System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M1 Ref: #562-Joule Staffing - Edison

Engineering Manager Manufacturing • 5–10 years of engineering or facilities management experience in regulated manufacturing., • Strong knowledge of cGMP, FDA, OSHA, EPA regulations, and engineering validation principles. Summary The Engineering Manager is responsible for overseeing manufacturing equipment, utilities, facilities, and engineering operations to ensure safe, reliable, and compliant production. This role manages capital projects, preventive maintenance, engineering documentation, and safety programs under cGMP, OSHA, EPA, and state regulations. The position requires strong leadership to guide engineers and technicians, coordinate contractors, and support continuous improvement initiatives. Key Responsibilities: • Equipment & Facilities — Oversee maintenance and reliability of manufacturing equipment, utilities, HVAC, and cleanroom infrastructure., • Capital Projects — Lead expansions, installations, upgrades, and construction activities; manage CapEx budgets., • Automation & Improvement — Implement robotics, cobots, and automation solutions; drive cost‑saving initiatives., • Validation & Documentation — Manage SOPs, preventive maintenance systems, work orders, and validation protocols (IQ/OQ/PQ)., • Safety & Compliance — Ensure compliance with OSHA, EPA, and FDA cGMP standards; manage audits and incident investigations., • Leadership — Supervise engineers, technicians, and facilities staff; provide training and succession planning., • Vendor & Stakeholder Management — Coordinate contractors, suppliers, and service providers; present reports on budgets and projects. Qualifications: • Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Industrial, Environmental) or equivalent., • 5–10 years of engineering or facilities management experience in regulated manufacturing., • Strong knowledge of cGMP, FDA, OSHA, EPA regulations, and engineering validation principles., • Experience managing teams, contractors, and capital projects., • Familiarity with automation systems, robotics, and advanced manufacturing technologies.

Solco Healthcare U.S., LLC, Company Overview: Solco Healthcare is a top-ranked, high-growth generic pharmaceutical company dedicated to expanding patient access to high-quality, affordable medications. As the commercial arm of a vertically integrated global leader, we combine the agility of a mid-sized firm with the stability of a global supply chain. With a portfolio of over 50 FDA-approved products and a rapidly expanding pipeline, we foster a collaborative environment where every employee’s contribution directly supports our mission to improve healthcare outcomes across the U.S. Join us as we continue to set new standards of excellence in the generic pharmaceutical industry. SUMMARY Provide support to the Sales and Contracting functions for the Director of Contracts and Pricing through a variety of duties including maintaining customer pricing and rebate agreements in SAP, reviewing and resolving price discrepancies, and coordinating timely entry of forecasted customer usage. KEY RESPONSIBILITIES · Maintain and update contract pricing information in SAP and other reference systems, following established procedures. · Update forecasted customer usage and enter one-time buys in SAP. · Prepare regular and ad hoc reports on pricing, contract status, or other sales reports as requested. · Research pricing discrepancies and requests for price adjustments; process corrections or changes as appropriate within department procedures; prepare summaries of changes or corrections. · Protect and prevent disclosure of highly confidential customer pricing data. · Maintain and update master data used to prepare new product offers and net price files. · Assist in preparing product bids and/or individual product offers to customers. EXPERIENCE Required Skills and Education: · A Bachelor’s degree is required and/or comparable experience. · Previous/current work experience within the generic pharmaceutical industry. · Ability to possess advanced Microsoft Excel skills to maintain several complex spreadsheets and reports. · Familiarity with SAP is strongly preferred. · Must possess excellent communication skills, including well developed interpersonal skills and the ability to work directly with external customers and other internal business areas. · Good organizational skills and the ability to work independently on multiple projects in a fast-paced environment are required. · Accuracy and attention to detail are essential. REPORTS to: · This position will report directly to Solco’s Director of Contracts and Pricing. Salary Range: $60,000 - $65,000

Job Description Job Title: Packaging Mechanic I Location: Monmouth Junction, NJ Hours / Schedule: 2nd Shift | Mon–Thurs, 3:00 PM – 1:00 AM Type: Temp - Perm Compensation: up to $40 per hour (pending experience) Overview The Packaging Mechanic I supports the Packaging Department by maintaining and repairing packaging equipment. Responsibilities include troubleshooting, preventive maintenance, line changeovers / startups, equipment upgrades, and root cause analysis to ensure compliance with SOPs, cGMPs, and FDA requirements. Must have strong electronics / PLC (Programmable Logic Controllers) background with strong ability to troubleshoot and diagnose! Responsibilities Perform maintenance and troubleshooting on packaging equipment (fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc.) Conduct preventive maintenance, repairs, and continuous improvement activities Execute line changeovers and startups Support QA and Operations during packaging runs Ensure safe equipment operation at all times Requirements High school / GED Minimum 3 years of pharmaceutical / Biotech packaging mechanic experience Strong electrical background Hands-on experience with fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc. Must pass pre-employment and physical Proficient in manufacturing procedures, FDA regulations, cGMPs, SOPs Ability to read/interpreting safety, maintenance, and procedure manuals Basic PC skills Willingness to work overtime as needed Preferred Requirements Trade school or technical certification Physical Requirements Ability to lift up to 50lb Stand for extended periods Use of PPE as required Benefits System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M3 #LI-DS1 Ref: #558-Scientific

The Procurement Operations Specialist is a third-party contract role that oversees the end-to-end lifecycle of R&D and manufacturing suppliers. This role balances strategic procurement (supplier management, onboarding, performance) with strict quality compliance. The candidate will act as the primary owner of the Veeva Quality Management System (QMS) workflow for external vendors, driving audits, change controls, deviations, Supplier Corrective Action Requests (SCARs), and Corrective and Preventive Actions (CAPAs). A Procurement Operations Specialist ensures that an organization's purchasing activities, vendor materials, and supplier networks meet internal quality standards and external regulatory requirements. Core Responsibilities 1. Supplier Management & Procurement • Serve as the primary operational and quality liaison between pharmaceutical manufacturing/R&D teams and external suppliers., • Manage supplier performance metrics, conduct regular business reviews, and mitigate supply chain quality risks., • Oversee the qualification and onboarding process for new raw material, API, and clinical trial suppliers., • Participate in Impact Assessments, Supplier assessment, Supplier and Material Changes Require Formal Evaluation and Supply chain traceability form and site quality overview. 1. QMS & Veeva Process Ownership • Direct and manage the full lifecycle of supplier workflows within the Veeva QMS platform along with internal and external stakeholder management., • Ensure all supplier-related data, documentation, and history are accurately maintained and audit-ready in Veeva. 1. Audits & Compliance • Partner with the QA, QC, MSAT, SCM, Production, Regulatory and other teams to coordinate, execute, and follow up on supplier quality audits., • Ensure suppliers adhere to cGMP, FDA, EMA, and other relevant global regulatory frameworks. 1. Change Notifications, SCARs, and CAPAs • Evaluate and process Supplier Change Notifications (SCNs) to assess their impact on R&D or manufacturing processes., • Issue and track SCARs when supplier materials or services fail to meet established specifications., • Lead root-cause analysis investigations with suppliers to develop, implement, and close out effective CAPAs. Qualifications and Skills • Education: Bachelor's degree in supply chain, Quality Management, Life Sciences, Engineering, or a related discipline., • Experience: 3 to 5+ years of experience in quality assurance, vendor management, or procurement compliance within a regulated industry., • Regulatory Knowledge: Familiarity with standards such as ISO 9001, AS9100, cGMP, or FDA regulations depending on the sector., • Certifications: Preferred credentials include ASQ Certified Quality Auditor (CQA) or Lean Six Sigma.

Job Description Job Description Date August 2026 Location 2 Kings Arthur Court / 1300 Airport Road, North Brunswick NJ Title Associate. Housekeeping Department Housekeeping Reports to Supervisor, Facility Custodial FLSA (Exempt or Non-Exempt Non-Exempt Role Overview Housekeeping Associates are responsible for thorough and outstanding cleanliness of the entire facility, with particular attention to the locker rooms, restrooms, high traffic areas, lunchrooms, labs, warehouses and offices. Housekeepers perform repetitive housekeeping tasks in assigned areas to meet given standards using safe work practices and proper housekeeping techniques and will also perform duties in multiple buildings for daily roles, back-up support, special projects, and special events. Areas of Responsibility • Assists in setting up, serving food for company events, and performs clean up, • Responsible for satisfactory and timely completion of assigned cleaning area according to schedule which can include dusting/cleaning lunchroom sinks, tabletops, counters, refrigerator/microwaves, removing trash, restroom cleaning, and restocking restrooms., • Will be able to wipe down sinks, partitions, and stainless steel., • Mop production areas, washrooms, and lunchrooms, • Replenish cafeteria supplies, • Straighten areas, such as lobbies, conference rooms, locker rooms, & break rooms., • Clean window blinds and draperies, • Reports equipment/cleaning product needs and malfunctions to supervisor in a timely fashion., • Safe and proper mixing and use of cleaning solutions and adheres to all safety precautions., • Collecting trash/recycling/ and for the proper disposal of trash/recycling in correct containers., • Maintain proper gowning and hygiene to ensure integrity of the product as per company policies., • Works extended hours and occasional weekend overtime., • Adheres to all safety protocols, procedures, and PPE requirements., • Cleaning of Warehouse racks, Fans Windows, Pipes, Removal of Cobwebs etc., • Use of Floor scrubbing machine., • Check all exterior of facility and clean/pick up debris as necessary., • Removal of Trash from all exterior trash cans., • Salting and removal of light snow as needed near entrances., • Other duties as assigned Requirements Education & Qualification: • High school graduate or GED equivalent, • 1+ years in housekeeping services, • Past work experience in an FDA regulated workplace and/or manufacturing industries preferred Certifications, Licenses, Credentials: • N/A Skills & Ability • Demonstrates ability to work in a team and assist others., • Must demonstrate timely and reliable attendance., • Must be able to speak, read and write basic English to communicate effectively with stakeholders., • Willingness to perform routine, repetitive tasks on a continuous basis., • Ability to use floor scrubbing machine, • Must be able to accomplish all responsibilities without supervision or other employee assistance after the training period is completed, and to do so without injury to oneself or other individuals., • Must be able to work around tablet, capsules, powder and cleaning products. Physical Requirements (lifting, etc.): • Must clean, walk, stand for a minimum of 6 hours per shift, • Must be able to push & pull a janitor’s work cart or Zamboni floor cleaner of 15 – 25 pounds and be able to lift up to 20lbs.; occasionally lift and move up to 35 pounds., • Uses hands to finger, handle, feel, lifting to waist height and/or above shoulder height, reaching overhead, frequent bending from waist, or squatting, lean over equipment as well as kneeling on the floor to clean under furniture; mopping/vacuuming/sweeping., • Occasionally works from a rolling ladder or step stool., • Must be able wear all PPE including lab coat, face mask, booties, gloves, safety glasses/goggles to work in and around manufacturing areas. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise and fumes. The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. Job Description Acknowledgement I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodations. 7:00 AM to 3:30 PM

Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines. Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our employees shape our future each day. Are you living your life's work? Entity: CCA-Penn Primary Care and Penn Specialty Practices Department: Penn Personalized Care Location: Penn Personalized Care-Dayton 12 Stults Rd. Suite 123 Dayton NJ 08810. Hours: Per Departmental Needs Full Time Summary: The Clinical Services Coordinator (CSC) assists the manager and/or physicians in maintaining a patient/customer focus, supports the delivery of high-quality care, shares a passion for patient and customer centered care, and assists in meeting or exceeding patient satisfaction and financial/operational targets. In addition to performing duties as a Medical Assistant (rooming patients, taking/recording vitals, performing tests/procedures), the CSC will be expected to oversee the daily schedule and operations of an assigned area/group. The CSC may also be required to perform PSA (Patient Services Associate) responsibilities. The CSC serves as the EMR expert and the liaison between staff and Managers/Physicians to ensure daily performance expectations are communicated and met. In the absence of the manager, the CSC may take on additional responsibilities. Responsibilities: • Coordinator Accountabilities, • Ensure self and assigned area(s) are compliant with all applicable federal, state, and local regulatory standards (ex OSHA, TJC, DOH, FDA, HIPAA, etc.), • Oversees the POCT process to ensure accuracy and compliance., • Report and act upon identified equipment/instrument malfunctions., • Manage the day-to-day planning, operations and problem solving for assigned areas ensure daily schedule, staffing, and performance metrics are met and changes communicated appropriately., • Monitor and coach real-time performance against pre-established expectations/metrics. May be responsible for gathering information for performance reviews., • Act as the communication link between the group he/she is leading, and management. Disseminates information to the group and forwards information back up to management., • Effectively works with manager and providers to establish, implement, and maintain practice policies, procedures and efficient systems that support daily operations., • Assists staff in resolving difficult patient situations or complaints., • Participates in the interviewing process and oversees the training of new hires., • Medical Assistant Accountabilities, • Promptly rooms patients, using EMR to alert provider that patient is ready: reviews past medical, surgical, family, smoking history, allergies, medications; notes corrections in EMR, notes medication refills needed for the physician to review, initiates self-management goal setting where appropriate, obtains patient's vital signs and documents in EMR, prepares chart for patient visit, understands insurance restrictions for lab work, referral needs, precertification requirements, etc., • Observes patient condition and communicates any abnormal data or changes to provider., • Assists patients as needed with walking, transfers, dressing, undressing, preparing for the exam, remains in exam room when necessary/requested., • Specimen management: obtain specimens for testing if applicable, performs laboratory and screening tests, records results in EMR and reconciles with logs where appropriate, documents and reports findings to providers, performs all quality controls as per Point of Care Testing guidelines, prepares specimens for transport as necessary., • Performs EKGs and other outpatient screening tests as per MD order and after properly preparing the patient; accurately documents results in EMR., • Assists with minor surgical procedures by handing instruments, maintaining sterile field, positioning of patient and other duties within scope of responsibility. Functions as a witness for procedural consents if required., • Responds appropriately to emergency/code situations., • Demonstrates competence in the observation, treatment, and care of the specific patients served in that practice, whose ages may range from neonate to geriatric., • Responsive and proactive telephonic patient care - including care coordination with specialists, ancillary services, hospitals, labs, home care agencies, and all other involved health services., • Obtain and scan documents as appropriate and required for visit: test results, faxes, reports, notes, referrals, etc., • Completes medical forms and other clinical requests for information as appropriate and required. Prepares and sends patient correspondence as required., • Ensures that the patient care areas are kept neat, orderly, well stocked and properly prepared., • Cleans, disinfects, and sterilizes instruments and equipment according to protocols and checks that the instruments and equipment are in proper working order. Sets up equipment and instruments as per practice protocol., • Maintain temperature log for refrigerator or room temperature as needed., • Clinical Care Associates (CCA) MAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD results, under the direction of the provider/orders and documents in EMR. Promptly performs call-backs as directed by provider, giving patients information within their scope of practice. Provides patients with follow up care instructions. Maintains medication storage closet inventory and security; checks expiration dates; removes outdated items. Performs daily code/crash cart checks as assigned. Credentials: • BLS/CPR, as a healthcare provider as per the American Heart Association (Required), • MA Certification (required within 90 days of hire) (Required), • Must successfully complete/pass EMR training/tests (Required) Education or Equivalent Experience: • H.S. Diploma/GED And 3+ years medical office experience required. Advanced degree (Associate's, Bachelor's, Master's) may be considered in lieu of experience. (Required), • Completion of an accredited Medical Assistant program (or higher level equivalent) Or 2+ years Experience working as an MA may be considered in lieu of MA program completion. Or 1+ year working as a Clinical Support Representative at Penn Medicine may be considered in lieu of MA program completion. (Required), • Associate's Degree Or Bachelor's Degree (Preferred) We believe that the best care for our patients starts with the best care for our employees. Our employee benefits programs help our employees get healthy and stay healthy. We offer a comprehensive compensation and benefits program that includes one of the finest prepaid tuition assistance programs in the region. Penn Medicine employees are actively engaged and committed to our mission. Together we will continue to make medical advances that help people live longer, healthier lives. Salary Range: $18.97 - $29.20/Hourly As part of their job offer, successful candidates are provided a specific rate, taking into consideration various factors including experience and education. Click here for information on UPHS's Benefits. Live Your Life's Work We are an Equal Opportunity employer. Candidates are considered for employment without regard to race, ethnicity, color, sex, sexual orientation, gender identity, religion, national origin, ancestry, age, disability, marital status, familial status, genetic information, domestic or sexual violence victim status, citizenship status, military status, status as a protected veteran or any other status protected by applicable law.

Pharmaceutical Sales Representative - Entry-Level (US BASED REMOTE)Our client is an award-winning biopharmaceutical company with over 30 years of experience developing and commercializing FDA-approved treatments for central nervous system (CNS) and respiratory diseases. We are seeking an ambitious,

The Manager/Sr. Manager, Regulatory Publishing is responsible for publishing, QC, and transmittal of eCTD submissions, as well as document formatting and report-level publishing. This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions and reports in alignment with health authority guidelines and industry best practices. Primary Responsibilities: • Using Acadia's eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions and reports in alignment with health authority guidelines and industry best practices., • For authored documents, ensure formatting is applied consistently according to Acadia's Style Guide., • As needed, prepare PDF documents for inclusion in regulatory submissions by editing bookmarks, hyperlinks, and other elements to ensure submission-readiness., • QC published eCTD submissions and reports, working collaboratively with teammates to resolve findings and issues., • Support authors and contributors to documents/reports to be included in regulatory submissions by advising on use of Veeva Vault RIM., • For clinical study reports, deliver Regulatory Operations kickoff slides (covering use of Veeva Vault RIM and tracking of appendices)., • For clinical study reports, work with SMEs/authors to track status of appendices and manage overall timelines for completion., • As needed, work with system business owners, IT, and QA to support system implementations and updates including execution of validation scripts. Skills Must have experience with/be proficiency in the following: • Thorough working knowledge of eCTD guidance (e.g., ICH, FDA, EMA, etc.), requirements, and technologies., • Experience in vendor selection, configuration, and implementation of regulatory information management systems and publishing systems., • Demonstrated ability to work collaboratively with IT, QA, and vendors to develop, implement, and maintain regulatory systems., • Working knowledge of tools and technologies related to document formatting/document-level publishing (e.g., Acrobat, DXC Toolbox, authoring templates)., • Understanding of computer system validation principles and change control processes., • Ability to work collaboratively with Regulatory Affairs, Medical Writing, and other functions to publish regulatory submissions and support management of documents and reports., • Demonstrated ability to effectively communicate in written and verbal media concepts related to regulatory systems and electronic submissions. Education Bachelor's degree in business administration, a life sciences discipline, information technology, etc.. A minimum of 5 years in Regulatory Operations or a related, relevant function.

Knowledge of supply chain tools and business processes. Animal Health/Pharmaceutical industry and supply chain experience in direct operations, and familiarity with FDA and other regulatory requirements. Business knowledge and ability to develop supply chain strategies.

Job Description: Regulatory Affairs Senior Associate The purpose of this role is to execute OTC regulatory activities for new products registrations and life cycle. Maintenance for the portfolio of products defined by the US Business Units. Key Responsibilities: • These responsibilities include some of the following..., • Represent USRA on assigned projects, provide guidance on OTC drug regulatory pathways (monograph,, • NDA)., • Develop regulatory strategies and documents for new product launches and maintenance of current products, • aligned with the regulations, • Develop regulatory label for OTC products, review claims and copy, • Participate in the review of promotional materials, • Support end-to-end regulatory compliance of products in remit., • Applies system and procedure updates to maintain up to date technical product records, • Identifies and participates in process improvements within US Regulatory Affairs, • Interact with colleagues in other global functions to support global programs, • Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete, • submissions, • Develop up-to-date knowledge of guidelines and regulatory requirements, as well as technical trends Qualifications: • Bachelor s degree in Pharmaceutical or Life Sciences or equivalent regulatory experience, • 2-4 years experience in regulatory affairs including chemistry, manufacturing and controls, and over the, • counter experience, preferably within a Client/Consumer Healthcare/Pharma related industry., • Experience and knowledge in Quality, product development and manufacturing areas., • Experience working on FDA applications, OTC monograph products, chemistry, manufacturing and controls, • Proficient knowledge in US FDA regulations, • Regulatory Affairs Senior Associate, • Excellent communications skills, stakeholder management and enjoys working in multidisciplinary teams, • Ability to manage prioritize projects of high complexity, • Experience leading end-to-end regulatory process in new product launches Additional Preferred Qualifications: • Knowledge and experience of US regulatory framework for OTC drugs, OTC medical devices, • Ability to ensure compliance standards and key performance indicators are met, • Regulatory expertise in knowledge of the regulatory lifecycle, • Ability to interact at many levels, • Technical knowledge, • Minimum 2 years of experience in regulatory affairs Competencies and Skills: • Agile, attention to detail, written and verbal communication skills using evidence and applying judgement to, • balance pace, rigor and risk

Established in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under such internationally recognized brand names as Colgate, Palmolive, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom's of Maine, Sanex, Ajax, Axion, Soupline, Haci Sakir, Suavitel, PCA SKIN, EltaMD, Filorga and Hello as well as Hill's Science Diet and Hill's Prescription Diet. Colgate-Palmolive is a leading consumer products company that serves hundreds of millions of consumers worldwide with brands and products across four core businesses Oral Care, Personal Care, Home Care and Pet Nutrition. We are committed to offering products that make lives healthier and more enjoyable, and programs that enrich communities around the world. Every day millions of people trust our products to care for themselves and the ones they love. Our goal is to use our technology to create products that will continue to improve the quality of life for our consumers wherever they live. A career at Colgate-Palmolive is an excellent opportunity if you seek a global experience, constant challenge, and development opportunities in an environment that respects work/life effectiveness. Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name! Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core valuesCaring, Inclusive, and Courageouswe foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all. As the Regulatory Affairs Project Manager, you will lead the planning, execution, and oversight of complex global regulatory submissions and ensure the rigorous maintenance of our Medical Device Quality Management System (QMS). This critical leadership role directly supports rapid portfolio growth, focusing on medical device and Rx drug innovation to meet the company's 2030 objectives. By driving continuous improvement in quality processes and partnering with cross-functional teams, you will safeguard compliance while accelerating commercialization timelines for North America. This position offers an exciting opportunity to spearhead high-impact projects that shape the future of our professional clinical portfolio. • Regulatory Submission Leadership: Leads cross-functional projects to prepare, review, and deliver complex regulatory submissions (e.g., 510Ks, NDAs, ANDAs, NDS) to the FDA and Health Canada on time., • QMS and GMP Compliance: Coordinates critical Quality Management System projects, ensuring all system implementations and process improvements align strictly with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 requirements., • Risk Management & Lifecycle Monitoring: Proactively identifies and monitors project risks, developing robust mitigation strategies to protect business continuity and minimize timeline impacts or regulatory penalties., • Environmental & Chemical Compliance: Manages evolving cross-category requirements for complex chemical reporting and environmental compliance data collection, including PFAS, TSCA, DSL, and SmartLabel initiatives., • Stakeholder Reporting & Automation: Serves as the primary point of contact for project-related inquiries, presenting regular updates to senior leadership and partnering with IT to automate regulatory workflows., • Continuous Improvement & Training: Heads "lessons learned" sessions and updates documentation standards (SOPs and WIs) while providing targeted training to team members on advanced project management methodologies. Bachelor's degree in Quality Management, Life Sciences, Regulatory Affairs, or a related technical field. At least seven years of experience in regulatory affairs, or a related compliance role within the medical device or pharmaceutical industry, with at least 2 years of project management experience. In-depth technical knowledge of medical device GMP standards, specifically ISO 13485, ISO 14971, and FDA 21 CFR Part 820. Direct professional proficiency using electronic Quality Management Systems (eQMS), document management systems (DMS), and advanced Project Management software such as Smartsheet. Proven track record of leading cross-functional teams and communicating complex technical regulatory info clearly to diverse stakeholders. Master's degree in Quality Management, Life Sciences, or Regulatory Affairs. Professional certification in Quality Management, such as a Certified Medical Device Auditor (CMDA) or Certified Quality Auditor. Advanced training or professional certification in Project Management (such as a PMP certification). Hands-on familiarity with the GreenlightGuru eQMS system or closely related medical device compliance platforms. Salary Range $124,000.00 - $174,000.00 USD Pay is determined based on experience, qualifications, and location. Salaried employees may also be eligible for discretionary bonuses, profit-sharing, and long-term incentives for Executive-level roles. Benefits: Salaried employees enjoy a comprehensive benefits package, including medical, dental, vision, basic life insurance, paid parental leave, disability coverage, and participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements. Additional benefits include a minimum of 15 vacation/PTO days (hourly employees receive a minimum of 120 hours) and 13 paid holidays (vacation days are prorated based on the employee's hire date within the calendar year). Paid sick leave is adjusted based on role and location in accordance with local laws. Detailed information regarding paid sick leave entitlements will be provided to employees upon hiring and may be subject to adjustments based on changes in legislation or company policies. Our journey begins with our peopledeveloping strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self, is treated with respect, and is empowered by leadership to contribute meaningfully to our business. Equal Opportunity Employer Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law. Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form should you require accommodation. For additional Colgate terms and conditions, please click here.

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our PV Case Operations team. Responsible for providing oversight of pharmacovigilance (PV) operations in the successful management of vendor and case processing deliverables in accordance with applicable regulations and agreements. Responsible for ensuring that assigned staff are appropriately prepared to support current and anticipated activities for receipt, processing, distribution/submission of reports from global development programs and globally marketed products. Responsible for ensuring inspection readiness; monitoring quality of PV deliverables; and monitoring compliance with case submission timelines as per regulatory requirements and agreements with License Partners and other parties. Incumbent may have a central role in audits and health authority inspections. This role has primary accountability for ICSR quality standards, CAPA ownership, KPI governance, and metrics-driven operational oversight across all case processing activities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. Work Location: Warren, NJ, Tarrytown, NY or Cambridge, MA 4 days per week on site 25% Travel may be required Discover your role: • Responsible for accurate and timely case processing deliverables across global development programs and marketed products., • Oversee ICSR quality review processes, including narrative quality, case validity, completeness of assessments, and source document reconciliation., • Establish and maintain tiered quality review frameworks and quality sampling strategies appropriate to case complexity, risk level, and product lifecycle stage., • Drive continuous improvement in ICSR quality by identifying trends, root causes of recurring errors, and implementing targeted remediation., • Assume a supporting role in interactions with auditors and Health Authority inspectors., • Assume a central role in responding to audit / inspection findings, • Lead root cause analysis (RCA) for quality deviations, case processing errors, and compliance failures; ensure findings are well-documented and actionable., • Develop, own, and track Corrective and Preventive Actions (CAPAs) to closure, including scheduling and conducting effectiveness checks post-implementation., • Ensure CAPA commitments made to health authorities, auditors, or internal quality teams are met within agreed timelines; escalate risks proactively., • Track and analyze operational metrics including case volumes, processing cycle times, resource utilization, overtime trends, and vendor performance benchmarks., • Develop and maintain vendor performance metrics frameworks; conduct regular governance meetings to review performance against contractual SLAs., • Ensure compliance with all regulations, guidelines, guidances and Regeneron SOPs and Working Instructions governing pharmacovigilance., • Responsible for mentorship and active support of assigned staff., • Responsible for ensuring deliverables and interests are communicated to senior management, internal partners, and external partners in a timely manner., • Skillful management and resolution of issues, which may, depending on complexity, require effective escalation., • Manage workload in meeting compliance objectives, optimizing job performance/contributions, and achieving high levels of work quality. This role requires: • Minimum Bachelors Degree, Advanced Degree preferred; with 10 years of Pharmacovigilance/Drug Safety/PV Quality experience., • Previous Pharmacovigilance/Drug Safety experience in pharmaceutical / biotech industry, • Well informed on relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required., • Experience with managing and supervising teams on complex projects. Demonstrated success in working on cross-functional teams, • Contributes to and manages organizational projects and goals to support their timely completion., • Assist group members with their activities, as needed. Generally, accomplishes tasks through Individual Contributors or other managers. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on?site. Please speak with your recruiter and hiring manager for more information about on?site expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Salary Range (annually): $157,200.00 - $256,600.00

The Regulatory Affairs Strategist is responsible for developing and executing regulatory strategies that support the approval and lifecycle management of pharmaceutical products. The ideal candidate will possess strong working knowledge of FDA regulations (including IND and NDA processes), internati

The End-to-End Project Manager (E2E PM) will lead several new Abbreviated New Drug Application (ANDA) project launch teams, starting with developing a regulatory filing strategy through the commercialization of products following FDA approval.

Own digital content governance across consumer channels, ensuring timely publication, regulatory compliance, content lifecycle management, and alignment with evolving brand priorities. Ensure all promotional activities, digital content, and paid media programs comply with FDA promotional guidelines,

Tris Pharma, Inc. is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories. Our science and technology make us unique, but our team members set us apart; they're the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success. We have an opening in our Monmouth Junction, NJ office for an experienced Associate Director or Director, Advertising & Promotions to join our Regulatory Affairs team. Title and salary commensurate with experience. This position provides senior regulatory oversight for the review and approval of promotional materials and related external communications for products. Reporting to the Head, Regulatory Affairs Advertising and Promotion, the incumbent helps ensure materials are accurate, balanced, substantiated, consistent with Food and Drug Administration (FDA) approved labeling and compliant with applicable FDA regulations, guidance, industry standards and company policies. She/he supports compliant business execution by providing strategic regulatory advice, leading complex promotional reviews, managing FDA submission requirements and improving review processes. The incumbent serves as secondary company contact to the FDA Office of Prescription Drug Promotion (OPDP) and helps ensure materials are submitted to the FDA in an accurate, compliant and timely manner to meet company goals. Primary duties/responsibilities: • Reviews and approves advertising and promotional materials ensuring compliance with applicable FDA laws, regulations and guidance documents, • Provides strategic input and clear regulatory advice towards the development of compliant yet competitive advertising and promotional material, • Key resource for regulatory advice on promotional and advertising initiatives throughout the company, • Maintains continued awareness and understanding of new and existing FDA regulations, guidance documents and enforcement actions regarding advertising and promotion of pharmaceutical products and communicates these to PRC and senior management, as needed, • Provides training regarding FDA expectations on advertising and promotion, as requested, • Provides strategic input on regulatory requirements for claim substantiation for desired promotional claims to enhance marketability of product portfolio, • Prepares and approves Form FDA-2253 submissions to OPDP, • Contributes to, and drives, Advertising and Promotion regulatory process improvements in relevant areas, as needed Requirements: Special knowledge or skills needed and/or licenses or certificates required: Associate Director - PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 3 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED -OR- Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum 7 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED Director - PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 4 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED -OR- Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum 8 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED FOR ALL LEVELS: • In-depth knowledge of FDA regulations and their interpretation relevant to prescription drug advertising, promotion and labeling REQUIRED, • Direct experience interacting with FDA OPDP REQUIRED, • Ability to influence without direct authority REQUIRED Work Arrangements: We are a HYBRID work environment requiring candidates to be able to work majority of week in our NJ office. Anticipated salary range: Associate Director - $160 to 180K/yr. Director - $185 to $230K/yr. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our Regulatory Affairs Advertising and Promotion team. This position requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). They will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial team's objectives, while maintaining the necessary state of compliance and corporate integrity. Work Location: Sleepy Hollow, NY or Warren, NJ 4 days per week on site Discover your role: • Management of US and Global (if applicable) regulatory activities associated with advertising and promotion of the company's marketed products, as well as commercial development of pipeline products. Manages commercial activities from a regulatory advertising and promotion perspective with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director., • Creatively advise on the development of product messages and materials across multiple functional areas., • Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs, • Provide review of US and Global (if applicable) product and disease state materials/communications, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance., • Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal., • Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies, • Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions., • Responsible for compliance with promotional material submissions to FDA on Form 2253, • Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications, • Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; provide guidance to stakeholders with respect to impact of enforcement activities on the company policies., • Provide input to direct management with respect to process improvement for promotional review activities and establishment of portfolio wide standardization of policies, • Ability to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders, • Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports, • With minimal guidance from management, help provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities, • Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising. This role requires: • A minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion, • At minimum, a Bachelor's degree (BS) from an accredited College or University in Life Sciences. Advanced degree (Masters, Pharm D, Ph.D., MD or DO) preferred in the field of medicine or science. Regulatory experience can offset education requirements., • Advance knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion, • Experience with pharmaceutical products required, biologics experience is a plus, • Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred, • Ability to review promotional materials and interact with FDA OPDP/APLB and managing launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice, • Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable, • Ability to influence cross-functional teams and interact with senior management

Established in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under such internationally recognized brand names as Colgate, Palmolive, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom's of Maine, Sanex, Ajax, Axion, Soupline, Haci Sakir, Suavitel, PCA SKIN, EltaMD, Filorga and Hello as well as Hill's Science Diet and Hill's Prescription Diet. Colgate-Palmolive is a leading consumer products company that serves hundreds of millions of consumers worldwide with brands and products across four core businesses Oral Care, Personal Care, Home Care and Pet Nutrition. We are committed to offering products that make lives healthier and more enjoyable, and programs that enrich communities around the world. Every day millions of people trust our products to care for themselves and the ones they love. Our goal is to use our technology to create products that will continue to improve the quality of life for our consumers wherever they live. A career at Colgate-Palmolive is an excellent opportunity if you seek a global experience, constant challenge, and development opportunities in an environment that respects work/life effectiveness. Role Summary The Senior Director, Global Consumer Affairs provides executive leadership and functional governance for the worldwide Consumer Affairs organization. This critical role is responsible for transforming consumer care into a primary catalyst for brand loyalty, strategic product innovation, and consumer retention. The Senior Director establishes a forward-thinking consumer care vision that functions as an insights engine, collecting consumer feedback data from various channels and leveraging AI and data analytics to deliver actionable consumer intelligence directly to internal stakeholders. This role institutionalizes and scales best practices in omnichannel consumer care, ensures Consumer Affairs regulatory compliance and brand risk mitigation globally. Responsibilities • Strategic Leadership & Enterprise: Drive strategic alignment across commercial divisions' objectives to transition the global service function to support business growth and brand equity. Measure and optimize impact from proactive insights and resolutions., • Global Compliance & Strategic Risk Mitigation: Champion regulatory compliance across global and regional frameworks while deploying data analytics as a proactive Quality tool. Institutionalize key product and regulatory data collection to eliminate liability, mitigate product recalls, and partner with IT to source and scale modern compliance platforms., • Omnichannel Agility & Consumer Experience Excellence: Architect consumer strategies across all digital and voice touchpoints, including social media, SMS, live chat, and email. Advance channel engagement using data analytics, AI and intelligent automation, ensuring seamless and efficient consumer experiences., • Consumer Advocacy & Voice of the Consumer (VOC) Insights: Amplify the voice of the consumer across the enterprise by driving optimized usage of first-party data and capabilities translating consumer feedback into actionable intelligence for Marketing, R&D product development and packaging innovation., • Situational and Reputation Risk Management: Formulate proactive identification matrices for potential reputational risks and establish communication frameworks. Transform company policies into clear messaging., • Talent Transformation: Develop and implement strategy to evolve contact center Representatives into omnichannel consumer advocates. Develop and grow internal talent and organizational capabilities for the future. Required Qualifications Bachelor's Degree in Business Administration, Marketing, Communications, Data Analytics, or a related discipline 12+ years of progressive experience in Global Consumer Affairs, consumer Experience, Consumer Insights, or a closely related field. Progressive leadership experience within global, highly regulated Consumer Packaged Goods (CPG) organizations or pharmaceutical industry 10+ years of senior leadership experience managing large, globally distributed, and matrixed teams (both direct and dotted-line reporting). Outstanding communication and collaboration skills. Track record of building strategic partnerships with Executive Leadership, R&D, Quality, Legal, Regulatory, and division Marketing to leverage consumer insights into action Experience overseeing global consumer center contact center platforms. Previous responsibility for 3rd party contact center strategic sourcing, partner selection, contract negotiation, and managing global vendor KPIs/SLAs. Proficiency in regulatory (e.g FDA) and data privacy compliance (e.g., GDPR, CCPA/CPRA) within the consumer care ecosystem. Experience and ability to develop Consumer Affairs data strategy that leverages deep consumer interactivity and drives optimized actions enterprise-wide. Preferred Qualifications MBA or Master's degree in Business, Data Science, or Consumer Experience Management to support the high-level modeling and analytical demands of the role Experience designing and deploying modern, omnichannel contact center platforms that maintain seamless, end-to-end consumer context across voice, digital, and social media channels Demonstrated expertise in modeling and leveraging data to influence executive decision-making Organizational design, talent upskilling, and change management. Compensation and Benefits Salary Range $235,000.00 - $275,000.00 USD Pay is determined based on experience, qualifications, and location. Salaried employees may also be eligible for discretionary bonuses, profit-sharing, and long-term incentives for Executive-level roles. Benefits: Salaried employees enjoy a comprehensive benefits package, including medical, dental, vision, basic life insurance, paid parental leave, disability coverage, and participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements. Additional benefits include a minimum of 15 vacation/PTO days (hourly employees receive a minimum of 120 hours) and 13 paid holidays (vacation days are prorated based on the employee's hire date within the calendar year). Paid sick leave is adjusted based on role and location in accordance with local laws. Detailed information regarding paid sick leave entitlements will be provided to employees upon hiring and may be subject to adjustments based on changes in legislation or company policies. Our Commitment to Inclusion Our journey begins with our peopledeveloping strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self, is treated with respect, and is empowered by leadership to contribute meaningfully to our business. Equal Opportunity Employer Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law. Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form should you require accommodation. For additional Colgate terms and conditions, please click here.

Job Description Position Description: SUMMARY:The Encapsulation Mechanic / Operator is responsible for setting up, operating, assembling, disassembling, cleaning, and troubleshooting encapsulation machines and related equipment. This position ensures consistent and efficient production of soft gelatin capsules in compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (cGMPs), and safety standards. The role requires strong mechanical aptitude, attention to detail, and the ability to maintain equipment performance to meet production quality and quantity standards.ESSENTIAL DUTIES AND RESPONSIBILITIES:•\tAssemble, disassemble, clean, and set up encapsulation machines and auxiliary equipment as per SOPs.•\tOperate encapsulation equipment efficiently to meet daily production targets while ensuring capsule quality and consistency.•\tPerform equipment adjustments, preventive maintenance, and minor repairs as required.•\tTroubleshoot mechanical issues to minimize downtime and coordinate with maintenance when necessary.•\tRecord equipment and production data accurately in batch records and logbooks.•\tFollow all cGMP and safety regulations, including use of personal protective equipment (PPE).•\tMaintain cleanliness and organization of the work area.•\tAssist in training new operators or mechanics as needed.•\tEnsure compliance with all company policies, SOPs, and FDA requirements.EDUCATIONAL QUALIFICATION:•\tHigh school diploma or equivalent required.•\tMinimum of 2+ year of experience in encapsulation, injection molding, tablet operations, or other mechanical/machine operation roles.•\tFluent English communication skills to read/interpret SOPs, complete documentation, and communicate issues effectively.•\tManual dexterity for handling tools and assembling/disassembling equipment.•\tPhysical ability to stand and walk for extended periods, and to push, pull, or lift up to 50 pounds.Work Environment and Physical Requirements:•\tAbility to stand/walk for most of the work shift and perform repetitive operations.•\tPeriodically push/pull large containers (up to 500 lbs with wheels) and lift items up to 50 lbs.•\tExposure to moderate noise levels, warm temperatures, and oily/wet conditions—hearing protection and slip-resistant footwear required.•\tMust wear required PPE, including protective eyewear, gloves, uniforms, hairnets, and steel-toed shoes.•\tMust be able to perform job duties safely without endangering self or others.

Job Description The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access” to cutting edge trials throughout the United States and Europe. We are seeking an Infusion Nurse. The Infusion Nurse is responsible for providing direct patient care to individuals who are participants in research protocols that are conducted at START. The Infusion Nurse uses appropriate professional judgment and decision-making in planning and providing care. Location: 629 Cranbury Road, East Brunswick, New Jersey 08816 Work Schedule: 8am-5pm, Monday-Friday The hourly pay rate for this role is $55/hour-$64/hour. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience. Patient Care • Administer chemotherapy/immunotherapy/investigational agent to participants (inclusive of parenteral) according to the protocol and applicable regulations., • Perform study-related activities including but not limited to venipuncture, obtaining blood specimens, IV insertion, and venous access device (central line) management, ECG collection, and vital signs., • Provide patient education regarding participation in a clinical trial, chemotherapy/immunotherapy/investigational agent administration and potential side effects. Protocol management tasks • Work with study team to ensure that study related procedures, drug administration, labs, vital signs and ECG are completed. Education & Experience • High School Diploma or GED., • Licensed Registered Nurse in practicing state., • 2 - 4 years of experience in peripheral IV insertion and management of venous access device(s). Preferred Experience • Bachelor's degree., • Oncology Certified Nurse (OCN) certification., • Clinical Trial and oncology experience., • Experience working with Microsoft Office, including Teams, Excel and Word. Best-in-Class Benefits and Perks We value the time, talent, and dedication our employees bring to START. Our commitment to your well-being and growth is reflected in a competitive compensation package—based on experience—along with comprehensive benefits designed to support you both personally and professionally: • 401(k) retirement savings plan with employer match, • Eligibility for an annual performance bonus, based on role and company results, • Generous paid time off and paid holidays, • Comprehensive medical, dental, and vision coverage and optional insurance options, • Company‑paid life and disability insurance for added financial protection, • Employee Assistance Program (EAP) providing confidential, no‑cost support for you and your family from day one, • Flexible FSA and HSA plans to support your financial wellness, • Commitment to a supportive environment that values balance, wellbeing, and flexibility, • We’re committed to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START, you’ll join a team that values continuous learning, professional growth, shared ideas, and a culture built on inclusivity and innovation. More About START START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators across its Network of clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world via our mission of “Hope Through Access”. Learn more at STARTresearch.com. Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online. We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.