Fda jobs in Edison, New JerseyCrear alertas

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.). 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: • 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., • 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

Job Description A Japanese food manufacturing is looking for a QC technician in Somerset, NJ. Title: Food QC Specialist Location: Somerset, NJ Salary: 25/hr Hours: Monday to Friday from 9pm to 6am (Starting from Sunday 9pm) OT Required Type: Direct-hire, full-time will an excellent benefit package Responsibility: -Testing of raw materials, work-in process and finished products. -Conducting environmental testing for cleaning and sanitary verifications. -Conducting internal inspections (GMP walk through, record checking, etc.) -Following strict regulatory and internal guidelines. -Serving as an active member of Food Safety Management Team. -Documenting, reviewing documentation, and creating quality-related report -Performing verification and validation of production processes and equipment. -Collaborating with other employees to address and solve the quality issues promptly. -Performing other functions as trained and requested by QC manager and Supervisor. Skills and Qualifications: -High School degree or higher -5+ year working experience in food and Beverage Manufacturing as QC or production leader -Proficient of Food Safety, cGMP, Sanitation Program, and HACCP -Knowledge and experience of SQF, FDA regulations, and FSMA/PCHF are plus-Fundamental computer skills (e-mail, Excel, Word, PowerPoint.) -Self-disciplined and Self-motivated -English, Spanish (Preferred but not required) -Ability to lift-up to 40lbs.-Ability to work in various work conditions (hot, humid, cold, wet). Company DescriptionWe are a Talent Acquisition/People Operation (HR) group that connects people to careers and professional growth. Would you like to look for a new job opening to expand your career path or a new applicant for your opening position? Then you are in the right place to start! TOP Group has grown from a single office in New York in 1992, to one of the global leaders in Japanese-related talent solutions today. As one of the first Japanese staffing agencies in the U.S., we started our focus in Finance but quickly expanded to other industries such as Technology, Freight Forwarding, Trading, and Manufacturing. We have offices in New York - Head Quarters, San Francisco, Los Angeles, and Houston. We have been expanding to Mexico to assist the Japanese corporations and become the #1 Japanese Recruiting Agency in Central America. Our Industries include: ●\tIT/Innovation ●\tManufacturing ●\tTrading ●\tLogistics ●\tEngineering ●\tOil & Gas ●\tCPA/Accounting ●\tFinance/Bank ●\tEntertainment If you are open to new job opportunities or interested in developing your career path, please follow our page, and let’s connect! You are more than welcome to InMail recruiters below. Unsure of which office to connect to? No worries! We will direct you to the nearest office for your desired location. For more information, please visit our website. are a Talent Acquisition/People Operation (HR) group that connects people to careers and professional growth. Would you like to look for a new job opening to expand your career path or a new applicant for your opening position? Then you are in the right place to start!\r\n\r\nTOP Group has grown from a single office in New York in 1992, to one of the global leaders in Japanese-related talent solutions today. \r\n\r\nAs one of the first Japanese staffing agencies in the U.S., we started our focus in Finance but quickly expanded to other industries such as Technology, Freight Forwarding, Trading, and Manufacturing. \r\n\r\nWe have offices in New York - Head Quarters, San Francisco, Los Angeles, and Houston. \r\n\r\nWe have been expanding to Mexico to assist the Japanese corporations and become the #1 Japanese Recruiting Agency in Central America.\r\n\r\nOur Industries include:\r\n●\tIT/Innovation\r\n●\tManufacturing\r\n●\tTrading \r\n●\tLogistics\r\n●\tEngineering \r\n●\tOil & Gas\r\n●\tCPA/Accounting \r\n●\tFinance/Bank\r\n●\tEntertainment\r\n\r\nIf you are open to new job opportunities or interested in developing your career path, please follow our page, and let’s connect! You are more than welcome to InMail recruiters below. Unsure of which office to connect to? No worries! We will direct you to the nearest office for your desired location.\r\n\r\nFor more information, please visit our website.

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. Job Description Job Summary: Under minimal supervision, the Quality Assurance Specialist III will ensure systems and processes are in a state of compliance with regard to internal, regulatory, and industry standards. He/she will promote a culture of quality for the Company. Candidates in this position will routinely report on the performance of the Quality System to senior leadership. Additionally, candidates will identify CAPAs, Deviations, Investigations, Change Controls, Process Improvements, and Root Cause Analysis. Candidates will participate in both internal (annual, in-process, for cause, etc.) and external (client, regulatory agencies, accreditation bodies, etc.) audits. Essential Duties/Responsibilities: • Participate in all aspects of Quality Assurance to ensure regulatory activities are performed in compliance with both internal procedures and external cGXP/ISO requirements., • Maintain the internal auditing program to ensure the established techniques are followed and understood., • Participate in the planning, preparation, and hosting of customer and regulatory audits; respond to audit reports and implement resolution of audit findings., • Maintain the Management Review process., • Maintain the laboratory proficiency testing program., • Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP-related items, as needed to help minimize laboratory errors and audit findings., • Support quality event investigations to completion using formal root cause analysis tools., • Support periodic summaries of audit outcomes and risk statements that identify whether there are uncontrolled risks within the QMS., • Maintain the list of approved suppliers and subcontractors., • Audits various reports prior to issuance (e.g. analysis reports, method validation reports, research and development reports (as needed), special project reports, etc.). Serve as site contact for all quality inquiries on analytical reports and related documentation., • Audit methods, work instructions, deviations, investigations, corrective actions, preventative actions, risk assessments, and instrument qualification/calibration paperwork., • Maintain site-specific procedures including the Quality Manual, Standard Operating Procedures, and other site-specific Quality Assurance documents., • Create, revise, review, and approve newly written documents and document revisions., • Work with Operations Management to maintain the training program and ensure that laboratory personnel performing tests have completed all necessary training requirements., • Trains laboratory personnel in GXP/ISO procedures, practices, and guidelines., • Exist as a backup for all other Quality Assurance personnel.Qualifications Education: • 3-5 years of experience in Quality Assurance within a laboratory or regulated industry (e.g., pharmaceuticals, biotechnology, medical devices)., • Must have experience working in a GMP facility., • ISO 17025:2017 accredited lab experience preferred., • Moderate understanding of microbiology and/or chemistry-related terms and testing., • Moderate understanding of USP/EP/JP standards and guidelines., • Moderate understanding of laboratory regulations (FDA, ISO, GLP, GMP), • Must be a detail-oriented, self-initiating individual with strong interpersonal written and oral communication skills., • Displays sound judgment and ambition; is quality focused; displays good communication skills; good implementation and follow-up skills., • Hands-on experience and strong understanding of industry regulations and how to apply them including 21 CFR Part 11, 21 CFR Part 820, ISO 17025, USP, and GxP., • Hands-on experience with CAPA, change control, quality events, and validation documentation (IQ/OQ/PQ). Additional Information Positions are full-time, working (Monday-Friday 8:00am-5:00pm), overtime as needed. Candidates currently living within commutable distance to North Brunswick Township, NJ are encouraged to apply. Compensation: $60,000-$78,000/year 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 What Happens Next Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths. Your data As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations. Closing Date We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible. Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately, on this occasion your application has been unsuccessful. Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer. Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

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

Job Description POSITION SUMMARY The Quality Control Chemist-II is responsible for performing a variety of complex analytical testing, ensuring the quality of dietary supplements and OTC products through testing, documentation, and compliance with regulatory standards. This position also involves reviewing and maintaining SOPs, Testing Procedures, calibrations, and other controlled documents to support quality assurance activities. Additionally, the Chemist-II will assist with troubleshooting and minor repairs of laboratory equipment and support stability testing and documentation. This mid-level position will require more independent work, the ability to mentor QC chemist-I and Lab Tech personnel, and involvement in process improvements and corrective actions. ESSENTIAL FUNCTIONS (Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills and other characteristics. This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.) • Coordinates with other QC Supervisors and laboratory management so that the shared resources such as laboratory instruments, reagents, etc. are available for assigned staff to perform their job duties effectively and efficiently., • Performs the pharmaceutical OTC & Dietary supplement analysis to support OTC & Dietary Supplement manufacturing which includes assay, impurity, dissolution testing, content uniformity, and physical testing., • Conduct Analysis in compliance with cGMP requirements, compendia standards, and internal procedures., • Maintain accurate record of analysis and perform documentation to company standards, • Perform laboratory analysis right first time, contemporaneous documentation, analyze and document the results., • Notify manager immediately of nonconforming data or unexpected occurrences., • Reviews and analyzes the stability samples and associated analytical data, prepares or assists in preparing Stability Summary Reports for Annual Product Review Reports., • Reviews/Checks of analytical data by following test methods/SOPs., • Performs operational qualification on analytical instruments, analytical method verification/validations, validation protocols and reports for analytical methods., • Conducts laboratory investigation (OOS/OOT) under the supervision of laboratory management., • Organize work schedule to complete assigned tasks efficiently and on schedule., • Work under direction provided by supervisor and other duties as assigned, • Assist in Training and monitoring of the new hires (trainees) in learning or performing basic skills and assists in evaluating the need of any potential equipment for laboratory., • Ensures the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards., • Maintains knowledge of the latest guidelines of regulatory requirements of International Conference of Harmonization, USP, USFDA and OSHA. Complies with all regulatory/ in-house requirements may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation., • Assists in compilation of regulatory documents. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the experience and education required: EDUCATION & EXPERIENCE o Bachelors degree in Chemistry or related science field with eight (8) to ten (10) years lab experience in a pharmaceutical chemical or related industrial experience; preferably solid dosage forms manufacturing. Method Development experience is preferred. o Masters degree or higher with six (6) to eight (8) years of progressive lab experience in a pharmaceutical chemical or related industry; preferably generic pharmaceuticals. Method Development experience is preferred. o Demonstrated skills and experience in leading a group of QC Chemists. COMPUTER SKILLS o Basic knowledge of computers using MS Office, MS Outlook and business software systems commonly used in the pharmaceutical industry required. MATHEMATICAL SKILLS o Requires a strong knowledge of algebra, calculus and statistics and how they are applied. o Math skills commensurate with scientific background are required. KNOWLEDGE, SKILLS AND ABILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required: INDUSTRY KNOWLEDGE: Knowledge and experience of applicable FDA regulatory standards and requirements for the solid oral dosage manufacturing required. Knowledge of analysis of pharmaceutical dosage forms and raw materials utilizing HPLC, GC, ICP-MS, UV, TLC, dissolution testing, spectroscopic and wet chemistry techniques is a plus. COMMUNICATION SKILLS: Advance level of written and verbal communication skills with the ability to read, technical procedures or governmental regulations. Ability to write reports, and required documentations. REASONING ABILITY: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Must possess initiative and trouble shooting ability.

Job Description Position: Pharmacovigilance Supervisor Location: New Jersey (on-site) Salary: $80,000 to $100,000 per year FLSA Classification: Exempt Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit . Job Overview: The PV Supervisor will be a key member of the US PV Team making appropriate processes for the project according to regulations and SOPs, and managing PV projects and performing PV work independently. This person will have strong technical expertise, will be a collaborative team player and proactive problem solver. Additional tasks: • Manage PV projects independently, including communicating with clients, making project plan, prepare study-specific Safety Management Plans and controlling project progress., • Solve the problems of the PV project, and maintain good communication with clients., • Receive safety reports from various sources, appropriately processing case reports in the safety database, raising query, regulatory/site submission and follow up., • Safety updated report (DSUR, PSUR, etc.) writing and quality control., • Formulate literature search strategy and conduct literature search., • Support business bidding., • Attend department or project meetings and provide feedback on challenges/problems or successes., • Potentially responsible for establishing the PV team in the United States., • Bachelor's degree or other advanced degree in Medicine, Pharmacy, Nursing or equivalent Scientific or healthcare discipline or allied life sciences., • Minimum of 5 years of experience in pharmacovigilance, good experience and understanding of pharmacovigilance., • Knowledgeable of FDA PV regulations and relevant global regulations and guidance for clinical and post-marketing safety., • Experience in PV management of clinical trials., • Proficiency in Chinese (Mandarin/Cantonese) - including speaking, reading, and writing is highly desirable to effectively communicate with clients, stakeholders, and team members, and to manage documentation and correspondence in Chinese. Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You'll thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners and collaborators. Comprehensive benefit package: As part of our commitment to your well-being, we offer a comprehensive benefits package: • Insurance including Medical, Dental & Vision with significant employer contributions, • Employer-funded Health Reimbursement Account, • Healthcare & Dependent Care Flexible Spending Accounts, • 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance, • 401k plan with generous employer match Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! #LI-JB1

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. Job Description Job Summary: Under minimal supervision, the Quality Assurance Specialist III will ensure systems and processes are in a state of compliance with regard to internal, regulatory, and industry standards. He/she will promote a culture of quality for the Company. Candidates in this position will routinely report on the performance of the Quality System to senior leadership. Additionally, candidates will identify CAPAs, Deviations, Investigations, Change Controls, Process Improvements, and Root Cause Analysis. Candidates will participate in both internal (annual, in-process, for cause, etc.) and external (client, regulatory agencies, accreditation bodies, etc.) audits. Essential Duties/Responsibilities: • Participate in all aspects of Quality Assurance to ensure regulatory activities are performed in compliance with both internal procedures and external cGXP/ISO requirements., • Maintain the internal auditing program to ensure the established techniques are followed and understood., • Participate in the planning, preparation, and hosting of customer and regulatory audits; respond to audit reports and implement resolution of audit findings., • Maintain the Management Review process., • Maintain the laboratory proficiency testing program., • Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP-related items, as needed to help minimize laboratory errors and audit findings., • Support quality event investigations to completion using formal root cause analysis tools., • Support periodic summaries of audit outcomes and risk statements that identify whether there are uncontrolled risks within the QMS., • Maintain the list of approved suppliers and subcontractors., • Audits various reports prior to issuance (e.g. analysis reports, method validation reports, research and development reports (as needed), special project reports, etc.). Serve as site contact for all quality inquiries on analytical reports and related documentation., • Audit methods, work instructions, deviations, investigations, corrective actions, preventative actions, risk assessments, and instrument qualification/calibration paperwork., • Maintain site-specific procedures including the Quality Manual, Standard Operating Procedures, and other site-specific Quality Assurance documents., • Create, revise, review, and approve newly written documents and document revisions., • Work with Operations Management to maintain the training program and ensure that laboratory personnel performing tests have completed all necessary training requirements., • Trains laboratory personnel in GXP/ISO procedures, practices, and guidelines., • Exist as a backup for all other Quality Assurance personnel.Qualifications Education: • 3-5 years of experience in Quality Assurance within a laboratory or regulated industry (e.g., pharmaceuticals, biotechnology, medical devices)., • Must have experience working in a GMP facility., • ISO 17025:2017 accredited lab experience preferred., • Moderate understanding of microbiology and/or chemistry-related terms and testing., • Moderate understanding of USP/EP/JP standards and guidelines., • Moderate understanding of laboratory regulations (FDA, ISO, GLP, GMP), • Must be a detail-oriented, self-initiating individual with strong interpersonal written and oral communication skills., • Displays sound judgment and ambition; is quality focused; displays good communication skills; good implementation and follow-up skills., • Hands-on experience and strong understanding of industry regulations and how to apply them including 21 CFR Part 11, 21 CFR Part 820, ISO 17025, USP, and GxP., • Hands-on experience with CAPA, change control, quality events, and validation documentation (IQ/OQ/PQ). Additional Information Positions are full-time, working (Monday-Friday 8:00am-5:00pm), overtime as needed. Candidates currently living within commutable distance to North Brunswick Township, NJ are encouraged to apply. Compensation: $60,000-$78,000/year 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 What Happens Next Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths. Your data As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations. Closing Date We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible. Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately, on this occasion your application has been unsuccessful. Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer. Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Job Description Reliance Vitamin, LLC is a leader in the development and manufacturing of high-quality dietary supplements and nutraceuticals. We take pride in our innovation, integrity, and dedication to excellence. Join our growing Regulatory Affairs team and contribute to ensuring that our products meet the highest standards of compliance and quality. Job Summary: We are seeking a Senior Regulatory Affairs Specialist to support all aspects of product documentation, labeling compliance, and regulatory submissions. This role is key in ensuring that all dietary supplement products, labels, and materials comply with FDA, FTC, and international standards. You will collaborate closely with R&D, Quality, Purchasing, Marketing, and Operations teams, driving compliance from product development through commercialization. Key Responsibilities: • Develop and review supplement facts panels (SFPs) and product labels for dietary supplements, • Collect, review, and maintain supplier documentation and certifications (e.g., Vegan, Organic, Non-GMO, Kosher, Halal), • Approve finished product and raw material specifications; ensure compliance with MMRs and supplier data, • Lead and manage third-party certifications, renewals, and audits (e.g. USDA Organic, Non-GMO Project Verified, Kosher, Halal, Vegan, NSF) by coordinating applications/audits, collective evidence (traceability, mass-balance, segregation controls), maintaining required SOPs/records, and managing renewals and compliant label use, • Review product labels and marketing materials for compliance with 21 CFR Part 101 and related FDA/FTC regulations, • Support international registration and documentation (Free Sale Certificates, GMP, apostilled/legalized docs), • Manage regulatory and customer portals (e.g., TraceGains, Bamboo Rose, Specright), • Stay current on regulatory updates and translate them into actionable internal guidance, • Partner with cross-functional teams to ensure labeling, claims, and documentation accuracy Qualifications: • Bachelor’s degree in Chemistry, Biology, Nutrition, or related scientific field, • Minimum of 5 years of regulatory experience in the dietary supplement or nutraceutical industry, • Strong working knowledge of DSHEA, 21 CFR Parts 101, 111, and 117, • Experience with label review and regulatory documentation, • Excellent research, communication, and organizational skills, • Proficiency in Microsoft Word and Excel; familiarity with regulatory or ERP systems a plus Preferred Skills: • Experience with customer portals such as TraceGains, Bamboo Rose, or Specright, • Experience managing third-party certifications (USDA Organic, Non-GMO Project, NSF, etc.), • Ability to interpret scientific research and regulatory guidance Benefits: • 401(k), • 401(k) matching, • Dental insurance, • Flexible spending account, • Health insurance, • Life insurance, • Paid time off, • Vision insurance Work Location: In person Company DescriptionReliance Vitamin is a high growth consumer products company in the very “on trend” natural and organic space, and is comprised of three divisions: · Private Labeling of premium branded and private label products for various companies/retailers using 450 stock products and differentiating with over 50 Patented and Trademarked raw materials. · Contract Manufacturing of premium powders, tablets and capsules differentiating with over 50 patented and trademarked raw materials, specializing in probiotics and plant proteins. Customer base is branded, domestic and international companies. With over 30+ years in business, Reliance provides expertise and resources to deliver nutritional innovation that truly makes a difference in consumer’s lives. The Company is in the process of transforming to maximize its entrepreneurial culture and heritage while building enterprise practices to achieve sustainable performance.Reliance Vitamin is a high growth consumer products company in the very “on trend” natural and organic space, and is comprised of three divisions:\r\n\r\n· Private Labeling of premium branded and private label products for various companies/retailers using 450 stock products and differentiating with over 50 \r\n Patented and Trademarked raw materials.\r\n\r\n· Contract Manufacturing of premium powders, tablets and capsules differentiating with over 50 patented and trademarked raw materials, specializing in probiotics \r\n and plant proteins. Customer base is branded, domestic and international companies. \r\n\r\nWith over 30+ years in business, Reliance provides expertise and resources to deliver nutritional innovation that truly makes a difference in consumer’s lives. The Company is in the process of transforming to maximize its entrepreneurial culture and heritage while building enterprise practices to achieve sustainable performance.

Job Description Job Description Date 02/2024 Location 1300 Airport Road, North Brunswick NJ Title Lead, Quality Control Chemist Department Quality Control Reports to Manager, Quality Control Laboratory FLSA (Exempt or Non-Exempt Exempt Role Overview The Lead, QC Chemist performs specific routine analysis of samples of raw materials, in process, and finished products according to established (official and/or in-house) test procedures. Testing assesses the strength, identify, purity of the test samples and/or raw materials. The Chemist prepares reagents, standards, and solutions and may monitor and verify quality in accordance with statistical process and other control procedures. The Chemist maintains & organizes testing’s and compliance while working in a fast-paced environment with changing priorities. Areas of Responsibility • Performs assigned sampling, physical, chemical tests and assay on raw materials, active dietary ingredients, in-process, finished, and stability products in an FDA regulated lab environment. Uses a variety of wet chemicals, physical and instrumental techniques as well as routine QC instruments HPLC, GC, IR, Auto Titrator, Bulk Density, UV Spectrophotometer, Dissolution, Karl Fisher (KF), Potentiometer., • Troubleshoots HPLC, GC, QC instruments for specific tests in order to assist in determining the root cause of aberrant results and help in performing Lab investigations / OOS., • Evaluates daily raw data sheets for product samples and release, if needed., • Coordinates annual review of STPS / SOPS as per USPL procedures., • Prepare new methods and test procedures for new or existing raw materials and finished products., • Ensures compliance with company and customer specifications as well as federal, state and local regulatory requirements., • Perform floor supervision of QC Chemists for routine testing, if required., • Prepares and reviews QC related documents during and finishing of testing of sample. Submit all testing related documents like data sheets, chromatograms, spectras, instruments print outs in timely manner to Qc Documentation department to release the batch of raw material / finished product., • Prepares and/or Reviews Test Procedures, SOP's and Protocols as assigned., • Performs maintenance and calibrations of laboratory instruments /equipment, if required to help in-house calibrations., • Assures GMP compliance according to FDA CFR Part 111 and USPL SOPs / guidelines., • Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, GLP, documentation) when performing the assigned activity., • Trains new QC Chemists to perform instrumental testing., • Must be able to work extended hours as needed and occasional weekends., • Works in a safe and responsible manner to create an injury-free and incident-free workplace., • Complies with all job-related safety and other training requirements. Education & Qualification: • BS/MS in Chemistry or related scientific disciplines., • Five (5) years of basic chemistry techniques (can be academic) is a plus., • Ability to maintain integrity and honesty at all times and to communicate with transparency., • Ability to work independently or as part of a team., • Solid understanding of cGMP’s and GLP and is familiar with 21 CFR Part 11., • Strong working knowledge of Microsoft Word, Excel., • Good documentation practices and able to write simple, clear reports., • Meets commitments on time and practices time-management skills., • Seeks to identify continuous improvement needs., • Experience with Shimadzu LC2010, Nexera, GC2010, Thermo ICP-MS, Labsolution and Waters, • Ability to navigate office, lab, and/or plant floor working environments., • 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 and leaning 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 is regularly performed inside a laboratory 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., • May execute up to 20% of their work at the bench level either standing or sitting on a stool., • Work performed in a standard office environment is without unpleasant or hazardous conditions. 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. Office Hours: 8:30 AM - 5:00 PM 9:00 AM - 5:30 PM

Job DescriptionBenefits/Perks • Highly enriched & healthy work environment, • Excellent growth opportunities, • Competitive Pay 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 lifecyclefrom 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 JRSs 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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 • Bachelors degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or related field., • 25 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 (28C, -20C, 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 DescriptionObjectivePerspective Therapeutics is seeking a highly motivated hands-on scientist with expertise in sterile injectable drug products to join our dynamic CMC drug product team. This role is critical in supporting the development of sterile injectable formulations and drug product process development from early development through scale-up and commercial manufacturing. The successful candidate will play a pivotal role in developing and optimizing injectable radiopharmaceutical formulations and associated manufacturing processes in a cGMP-compliant environment. Working in a fast-paced, integrated, and multidisciplinary environment, the successful candidate is expected to collaborate cross-functionally while also delivering strong independent contributions that support product advancement to late-stage clinical development and commercialization.Objective • Serve as the technical subject matter expert (SME) for formulation and drug product process development., • Conduct formulation/process development studies, including comparability, stability, and compatibility assessments., • Lead scale-up and technology transfer activities to support manufacturing., • Draft detailed study plans to ensure that work is performed efficiently and in a scientifically sound manner, • Monitor experiments (e.g. process development, formulation optimization) and ensure complex data are interpreted in a scientifically correct way, • Support filter and container closure integrity validation studies and other special studies as necessary., • Collaborate with cross-functional teams including Analytical, Quality, Regulatory, and Manufacturing., • Author formulation and process development reports, study protocols, and regulatory CMC module 3 documentation to support late-stage IND and NDA submissions., • Ensure all work is performed in accordance with company policies, procedures and safety standards., • Ensure documents follow relevant regulatory standards (e.g., FDA, USP, ICH) and CMC guidelines., • Troubleshoot and propose scientifically sound solutions in collaboration with internal teams., • Provide technical support during regulatory inspections and audits, as needed.QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.Education/Experience, • Ph.D. or M.S. or B.S. in Pharmaceutics, Chemistry, or related field, • 5-7 years of hands-on experience in formulation development and sterile drug product process development using quality by design (QbD) principles., • Strong understanding of aseptic processing, formulation characterization, excipient compatibility, and container-closure systems, • Experience with QbD principles and risk-based development approaches., • Pharmaceutical product life cycle management, • Deep expertise in regulatory frameworks (FDA, EMA), and clinical/commercial manufacturing., • Familiarity with GMP quality systems and electronic document management systems., • Experience in radiopharmaceuticals or isotope-based therapeutics is strongly preferred.Knowledge / Skill / Ability, • Ability to prepare detailed study protocols and interpret complex data sets across multiple techniques., • Excellent communication skills, including the ability to explain technical concepts to cross-functional teams., • Prior radiochemistry experience and knowledge of radioactive material handling are a plus., • Strong organizational skills, with the ability to manage multiple priorities and meet tight deadlines., • Work independently and proactively in a highly matrixed environment.Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions., • Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels., • May be required to sit or stand for long periods of 8+ hours a day while performing duties., • Willingness to complete safety training within allotted time limits, and work in a team-based environment., • May require travel to Iowa up to 10%. Powered by JazzHR WawpTpaAzu

Job DescriptionCircadia Health built the world’s first FDA‑cleared, contactless remote‑patient‑monitoring system powered by AI. Our platform detects early signs of medical events such as CHF, COPD exacerbations, pneumonia, sepsis, UTIs, and falls—currently protecting 40,000+ patients every day. Our mission is to enhance patient outcomes and improve healthcare processes by providing cutting-edge solutions to healthcare providers and patients alike. As we scale, we’re hiring mission‑driven clinicians who want to pair hands‑on care with data‑driven insight. Position Description:Circadia Health is launching a new, proactive model of care aimed at improving outcomes through early intervention and consistent monitoring in skilled nursing facilities (SNFs). As part of this Proactive Care Program, we are seeking a dedicated Nurse Practitioner (NP) to lead on-the-ground efforts across two partner SNFs in New Jersey, located 13 miles apart. The NP will play a critical role working with the entire facility’s patient population (short and long term). This includes identifying and managing patients at risk — including new admissions, patients with out-of-range vitals (e.g., blood pressure, blood sugar, weight), those flagged by facility staff, Circadia’s AI Predictive Model, and/or patients with behavioral health needs. You will play a crucial role in our mission to enhance patient care through innovative solutions. You will be responsible for performing in-person patient assessments, prescribing necessary medication and treatments, developing individualized care plans and collaborating with the interdisciplinary team to ensure the highest standards of care.Key Responsibilities • Proactive In-Facility Rounding: Conduct initial and routine assessments on patients, prioritizing those flagged by Circadia’s AI powered monitoring system or facility staff. Prescribe all necessary medications and treatments under the covering physician agreement., • Data - Driven Patient Identification: Review alerts and trend analyses generated by Circadia’s platform to identify early signs of clinical deterioration. Verify and act on facility-initiated notifications within agreed response times., • Personalized Care Planning: Develop and update patient-specific care plans that integrate AI insights, evidence-based guidelines and resident goals. Set and monitor threshold-based interventions (e.g. BP, glucose, weight parameters)., • Interdisciplinary Collaboration & Education: Coordinate with facility clinical teams to ensure seamless hand-offs and follow-through on escalations and interventions. Communicate with physicians and/or specialists regarding patient care. Provide education to facility staff on Circadia’s platform and AI insights., • Continuous Quality Improvement: Track key performance indicators (e.g. hospital transfers, response times, guideline adherence) and participate in regular QAPI meetings to drive outcome improvement.KPIs, • Minimum 20 patient visits per facility per day, • Documentation completed within 24 hours for all patient assessments, follow ups, and any communications, • Review all Circadia flags and reports the same day while rounding in facilities, • Ensure individual care plans are up to date for any changes in condition, new risk or goals, • Partner with floor staff and nurses to ensure clinical follow-through on any interventions, • Attend and participate at the facilities QAPI meetings, • Provide brief in-services or huddles, as needed, • Track and review patient outcomes, • Comfortable navigating Circadia alerts, EMR, and documentation toolsQualifications, • Certified and licensed as a Nurse Practitioner in NJ, • Must have an active license and DEA # Medicare participation and ability to have company bill for services on your behalf, • Certification from ANCC (or equivalent) as an Adult, Family, Geriatric and/or Acute Nurse Practitioner, • 2+ years of Nurse Practitioner Experience working with complex adult populations, • Current NJ Driver’s License, • Comfort using technology such as Google Suite, multiple EMRs, Slack, AI transcription tools, • Ability to thrive in a fast-paced environment, • Comfortable in an adaptive and evolving environment, • English required, Spanish preferredBenefits, • Medical, dental, and vision coverage through Anthem BCBS (or equivalent), • 401(k) with employee contribution option, • Flexible PTO in accordance with company policy

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. 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. 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 Director, Clinical Research / Clinical 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. This role is based on site in East Brunswick, New Jersey. 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. Best-in-Class Benefits and Perks We value our employees’ time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including: • Comprehensive health coverage: Medical, dental, and vision insurance options provided, • Robust retirement planning: 401(k) plan available with employer matching, • Financial security: Company-paid life and disability insurance for added protection, • Flexible financial options: Health savings and flexible spending accounts offered, • Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided, • Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture. 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. 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 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, • 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 DescriptionJOB DESCRIPTION: Research Scientist (11-12) - I&S Oral Care North America 909 River Road Piscataway, NJ 08854 Monday – Friday, 8am – 4pm (with some flexibility) 6 months Perform appropriate Lab practices and procedures for making product formulation and testing of products. Follow product stability protocols. Maintain, monitor, validate and calibrate lab equipment, as necessary. Prepare reports, collect data analysis, and communicate progress and completion of tests to leadership. Maintain good record keeping habits. Responsibilities include: • Lead the development and implementation of new toothpaste formulas for North America - under the hello and Tom's of Maine brands., • Be the R&D point of contact for commercial teams for hello and Tom's key innovation., • Lead experimental designs to help identity launch formulations and production processes., • Make lab and pilot batches of formulations for stability testing and customer sampling., • Support Pilot Plant batches by preparing batch sheets, requesting raw materials, pre-weighing materials and batch execution., • Support plant trial batches at various North America locations as needed., • Manage multiple stability studies at the lab, pilot and plant scale, working with support groups (analytical, flavor, micro, etc) to deliver samples and follow up on results., • Create/maintain all required R&D documentation to ensure flawless, high quality commercialization., • This may include R&D project timelines, formula databases, tech transfer checklists, proof of claims documents, registration documents, NODs, change control documents and technical justifications., • Manage independent projects and collaborate with cross-functional teams, leveraging diverse perspectives to achieve key project goals and influence beyond your network, • Create and maintain all required documentation under GMP/GLP per FDA/ICH guidelines as required., • Validate new raw material suppliers and packaging as required., • Maintain a clean and organized working environment., • Work on multiple tasks with changing priorities., • Make day-to-day recommendations and escalate issues regarding formula development., • Stay abreast of supplier and competitor's new developments., • Abide by and follow all company standard operating procedures (SOPs) including those for product development, regulatory and safety., • Bachelor's or MS Degree in Chemistry, Chemical Engineering, Biochemistry, Food Science or related fields., • 4+ years of experience developing and/or implementing consumer products., • Experience scaling up formulations from the lab through pilot or manufacturing scale., • Technical understanding of related chemistry and science (for example: active deliveries, emulsions, surfactants, rheology, liquid chemistry), • Strong knowledge of ingredient chemistry to be able to understand how the interdependencies and interactions of raw material components affect formulation and process performance, • Able to multi-task and coordinate various simultaneous projects, • Strong oral and written communication skills, • Self-motivated but able to work well within a team environment, • Knowledge of cGMP /GMP and GLP, • Knowledge of equipment and procedures for making oral care formulations, • Experience running stability studies for OTC/Drug products, • Experience & understanding of producing formulations at the manufacturing scale., • Experience with claim substantiation., • Strong project planning and management experience, • Knowledge of Regulatory environment in North America and across the globe, • Previous laboratory experience preferred., • Must have hands-on experience with laboratory instruments., • Must be able to learn new procedures in a short period of time., • Must be able to follow SOPs and obtain reliable and accurate data., • Must be able to document data consistently and accurately., • Must be able to perform routine tasks daily#TB_PH #ZRCompany DescriptionFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CAFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

Job Description Job Description Date July 2021 Location 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, rest rooms, high traffic areas, lunchrooms, 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 • Purchasing of cleaning supplies, • 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. Education & Qualification: • High school graduate or GED equivalent, • 1+ years in housekeeping services, • 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., • 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 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., • 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 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. 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. 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 hiring a motivated Data Coordinator who will collect, enter/transcribe, and transmit/submit clinical data for assigned investigational drug studies. This position is onsite at our New Jersey Location (629 Cranbury Rd., East Brunswick, NJ 08816). The hourly rate for this role is $23-$25 per hour. However, hourly rate may vary depending on multiple individualized factors including market location, job related knowledge, skills, and experience. Essential Responsibilities • Collect, enter/transcribe, and transmit/submit clinical data in paper and/or electronic case report forms (CRFs), including correction and query resolution for assigned investigational drug studies., • Receive and request patient records/data from the study team as required to complete CRFs for assigned studies., • Review patient data for completeness and accuracy for assigned studies., • Coordinate and schedule monitor visits for assigned studies. This includes exit meetings with monitors to review data or queries., • Identify lab facilities used for assigned studies and communicate to the Regulatory Affairs staff so that lab certifications can be requested for the study file., • Review and utilize protocols as guides for study activities for assigned studies., • Assure that data entry remains current for all assigned studies., • Attend meetings as required for assigned studies. This includes, but is not limited to, site initiation meetings, monitor exit meetings, close-out visit meetings, and audit preparation meetings., • Be available and on-site, if required, during audits for assigned studies., • Bachelor’s degree or equivalent experience in lieu of degree., • Ability to accurately perform data review and CRF completion in its entirety with minimal direction., • Familiarity with medical terminology., • Travel required up to 10% of the time., • Sitting for extended periods of time., • Comprehensive health coverage: Medical, dental, and vision insurance provided, • Robust retirement planning: 401(k) plan available with employer matching, • Financial security: Life and disability insurance for added protection, • Flexible financial options: Health savings and flexible spending accounts offered, • Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided, • Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture. 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. 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 Title: Senior Customer Service Coordinator (Hybrid) Location: Somerset, NJ (3 days onsite / 2 days remote) Schedule: Monday–Friday, 8:30 am – 5:00 pm 18 month assignment to start Pay: 28.85/hour Are you a detail-oriented customer support professional with a passion for building strong relationships and supporting vital business operations? Kelly® in Partnership with Johnson and Johnson has exciting opportunities to work in the Somerset NJ area in a hybrid work schedule as a Senior Customer Service Coordinator! About the Role As a Senior Customer Support Services Coordinator, you’ll be the cornerstone of our order management process, providing exceptional service to both external customers and internal business partners across our operating companies. This hybrid role is perfect for candidates who are collaborative, organized, and committed to operational excellence, compliance, and continuous improvement. Key Responsibilities • Specialized Order Processing: Manage sophisticated order processing, including coordination of shipments and deliveries, fulfillment of controlled substance orders, and handling cases through multiple channels (phone, email, fax)., • Regulatory Compliance: Maintain thorough records and uphold rigorous compliance with guidelines set by GMP, SOX, DEA, FDA, PWC, and safety/environmental authorities., • Investigative Support: Validate, enter, balance, and edit specialty orders while applying policies, procedures, and regulatory knowledge., • Process Improvement: Handle requests for deviations; collaborate with team members to support business improvements and lean initiatives., • High school diploma or GED required; Bachelor’s degree preferred., • Minimum 4 years’ customer service experience, ideally with multitasking and handling competing priorities., • SAP knowledge (Atlas or ROTC) is required., • Proven background supporting customer service via phone calls and multi-media inquiries (email, fax, electronic system)., • Outstanding oral and written communication, organizational, and investigative skills., • Demonstrated team collaboration and strong interpersonal abilities., • Experience using MS Office, ERP systems, and related business software., • Knowledge or certification in Lean methodologies is a plus., • SAP experience with Atlas or ROTC modules, • Customer service expertise: managing orders/cases via phone, email, fax, and multi-channel inquiries, • Hybrid work schedule for work-life balance, • Inclusive, supportive team environment, • Opportunities for professional growth and development, • Make an impact on our company, customers, and community

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

Job Description 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 45 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. We are hiring a Per Diem – Pharmacist, Investigational Drug Section for our clinic in East Brunswick, NJ Address: 629 Cranbury Rd. East Brunswick, NJ 08816 This position offers competitive compensation of $70–$75 per hour, reflecting the expertise and value you’ll bring to our team. Position Summary: Join our Investigational Drug Service (IDS) team as a Per Diem Pharmacist, Investigational Drug Section. In this role, you will oversee all aspects of medication order verification, dispensing, and documentation for investigational drugs, conventional chemotherapy, and supportive care medications. You will provide pharmaceutical care, including patient interviews, medication education, and drug information for healthcare teams and patients. This position requires a high degree of autonomy and adherence to IDS SOPs and quality assurance guidelines. Essential Responsibilities: • Verify medication orders for accuracy, including dosages, calculations, and patient eligibility criteria., • Oversee preparation and dispensing of medications, ensuring compliance with double-check verification processes., • Provide patient counseling and drug information to healthcare teams., • Maintain effective communication and foster a positive, professional environment., • Manage drug inventories, documentation, and accountability for investigational and conventional medications., • Review new protocols and amendments; maintain accurate reports using IDS systems., • Ensure accurate EMR entries and maintain licensure and competency requirements. Required Skills & Abilities: • Knowledge of sterile compounding (USP <797>, USP <800>) and chemotherapy handling., • Proficiency with Microsoft Office, EMR systems, pharmacy software, and IRT systems., • Familiarity with Good Clinical Practice (GCP) principles., • Bilingual skills are a plus. Education & Experience: • Graduate of an ACPE-accredited School of Pharmacy., • Current New Jersey pharmacist license in good standing., • Minimum two years of hospital/clinic pharmacy experience., • Sterile compounding & chemotherapy certification required., • Preferred: Clinical trial experience, oncology specialty residency, and/or BCOP certification. 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 Summary The Maintenance Engineer ensures reliable operation and upkeep of all pharmaceutical manufacturing, packaging, utility, and facility equipment. This role requires strong mechanical, electrical, and automation troubleshooting skills, along with knowledge of pharmaceutical processes, cGMP, and FDA requirements. The engineer supports production, leads maintenance activities, and ensures safety, quality, and compliance. Key Responsibilities * Perform preventive maintenance, repairs, and inspections on manufacturing and packaging equipment. * Troubleshoot mechanical/electrical issues, reduce downtime, and coordinate vendor support. * Maintain maintenance records, write SOPs and protocols, and support FAT/URS/FRS documentation. * Manage spare parts, purchase requisitions, and equipment inventory. * Collaborate with Production, Quality, and Engineering; train operators/technicians. * Support commissioning/qualification of equipment and utilities. * Promote safety, follow cGMP, and ensure compliance with all regulatory standards. * Oversee direct reports and assign daily maintenance tasks. Requirements * Bachelor’s in Mechanical/Electrical Engineering or related field (Master’s a plus). * 3+ years of experience maintaining pharmaceutical manufacturing/packaging equipment (OSD preferred). * Strong troubleshooting, communication, leadership, and problem-solving skills. * Knowledge of utilities, HVAC, GMP, and safety practices. #ZR

Job Description Position Summary: We are seeking a Director of Technical Sales to lead commercial growth and technical engagement for our dietary supplement ingredient portfolio. As a key member of our management team, this individual will drive sales strategy, lead customer development, and bridge the gap between science and sales, helping customers bring innovative and effective nutritional products to market. This position reports directly to the CEO and will focus exclusively on the North American market. The ideal candidate has a strong technical foundation in nutraceutical or food ingredients, combined with commercial acumen and a passion for building long-term customer relationships in a mid-size, entrepreneurial environment. A formulation-level technical understanding is required to support scientific conversations and formulation guidance. Key Responsibilities: • Commercial Leadership, • Develop and execute sales strategies to grow revenue and market share across innovative ingredients among various dietary ingredient categories (e.g., amino acids, botanical extracts, sweeteners, functional compounds, probiotics, vitamins, and minerals)., • Build and expand relationships with dietary supplement brands, contract manufacturers, and formulators across North America., • Oversee key account development, contract negotiations, and pricing strategies to achieve revenue and profitability targets., • Collaborate with marketing to develop marketing activities and collaterals, promotional materials, and customer education tools., • Drive both new-business acquisition and growth of existing accounts, with emphasis on commercializing innovative ingredient solutions regardless of account type., • Achieve year-one goals centered on expanding awareness, market penetration, and sales traction of innovative ingredients within existing and new customer segments., • Technical Engagement, • Act as the technical voice for the sales organization—translating product science and formulation data into practical, customer-ready solutions., • Support customers with technical presentations, formulation guidance, and troubleshooting., • Coordinate with suppliers and internal QA/R&D to ensure compliance, quality, and technical accuracy in all customer communications., • Stay informed of emerging trends, new ingredient technologies, and relevant FDA/DSHEA regulations., • Leverage formulation-level expertise to advise customers on application challenges and communicate technical value propositions., • Strategic & Cross-Functional Collaboration, • Partner with global sourcing and supply chain teams to align sales priorities with supplier capabilities and inventory planning., • Provide market insights and customer feedback to support new product development and sourcing initiatives., • Represent the company at key trade shows, industry conferences, and supplier meetings., • Work closely with the CEO to align strategic growth priorities and scaling initiatives. Qualifications:, • Bachelor’s degree in food science, Nutrition, Chemistry, Biochemistry, or related field; advanced degree preferred., • Minimum 6 years of experience in B2B ingredient sales within the dietary supplement, nutraceutical, or functional food sectors., • Strong technical understanding of ingredient functionality, formulation, and applications., • Demonstrated ability to manage key accounts, lead sales growth, and deliver against revenue goals., • Excellent communication, negotiation, and presentation skills., • Experience working with international suppliers and distributors., • Willingness to travel domestically and internationally (30–50%)., • Ability to operate within a CEO-aligned reporting structure and navigate a fast-paced, entrepreneurial environment.Preferred Attributes:, • Hands-on leadership style suited for a collaborative, fast-moving mid-size organization., • Existing network of contacts among contract manufacturers and supplement brand companies., • Experience introducing new ingredients to the U.S. market., • Entrepreneurial mindset with a proactive approach to customer engagement and problem-solving. dXlHFjdS2x

Job DescriptionSalary: $45-55/hr. Job Title:Laboratory Relocation Project Manager Job Type:1yr Contract; ~ 40hrs/week Location:Lawrenceville, NJ and/or New Brunswick, NJ Target Contract Start:December 2025 About the Role: Do you have strongproject management and lab relocationskills? You will be the go-to person on-site, supporting lab moves from planning through execution, and ensuring every detail runs smoothly. As the single on-site point of contact, you will coordinate timelines and logistics, liaise with vendors and stakeholders, and manage accurate asset inventory, tagging, and labeling throughout the relocation. You will help ensure compliance with regulatory, OSHA, FDA, and GMP requirements and draw on 2 to 5 years of project coordination experience and strong communication skills. About The Company: MustardSeed PMO designs and delivers project management solutions for complex, regulated sectors. We build PMOs, plan, staff, and run projects and programs, and provide seasoned project managers on demand. Headquartered in West Chester, Pennsylvania, we serve U.S. companies with a fully U.S.-based, distributed team. Were known for fast, structured onboarding that plugs in quickly and builds momentum. Our frameworks improve communication, control, and execution to drive better decisions and measurable results. We support clients across life sciences, aerospace, food, tech, and financial services aligning PM discipline to each organizations stage. Key Responsibilities: • On-Site Coordination:Serve as the primary point of contact during laboratory relocations, ensuring projects stay on schedule and within scope., • Project Planning & Logistics:Assist in the development of relocation plans, including timelines, resource allocation, and risk management., • Asset Inventory, Tagging and Labelling:Responsibility to conduct accurate asset inventories matching customer asset registers against physical assets in the lab, creating gaps analysis and tagging/labelling assets for the move to the new location., • Customer Liaison:Serve as the single POC on site for the customer, supporting by answering questions, providing information, directing updates where needed and managing our relationship directly with end users and key stakeholders., • Vendor & Stakeholder Management:Liaise with third-party vendors, internal teams, and client stakeholders to facilitate smooth transitions., • Compliance & Safety:Ensure regulatory compliance (OSHA, FDA, GMP) is maintained throughout the move., • Issue Resolution:Identify and mitigate relocation risks, troubleshoot logistical issues, and escalate challenges as needed., • Documentation & Reporting:Maintain accurate records of project progress, relocation schedules, and vendor interactions. Qualifications & Experience: • 2-5 years of project coordination or project management experience (preferably in life sciences, or laboratory operations)., • Experience in laboratory relocations, facilities management, or supply chain/logistics is a plus., • Strong understanding of project management principles (PMP certification is a plus but not required)., • Excellent communication and stakeholder management skills to interact with researchers, lab managers, and vendors., • Proficiency in Microsoft Project, Smartsheet, or other PM tools is a plus., • A can do customer centric attitude along with being able to think and pivot quickly using your own initiative., • The ability to work in pressurized situations and environments. Additional Information: This is a 1099 contract position. MustardSeed PMO provides equal opportunity for all and prohibits discrimination and harassment of any kind.