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Global Product Development and Supply - Cell Therapy Analytical Development (CTAD) Job Number: 26-00847 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Global Product Development and Supply - Cell Therapy Analytical Development (CTAD) for our client in Summit, NJ. ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity! Position Overview: The Analyst is responsible for supporting the method transfer and analytical testing with moderate supervision as part of Cell Therapy Technical Operations (CTTO) Team. The analytical department is responsible for flow cytometry, cell-based potency, RT-qPCR/PCR and other analytical assays testing to support process characterization testing of the lentiviral vector and cell therapy drug product samples. This includes the ability to interface with multiple groups, independently perform tasks, interpret results, and troubleshoot. Responsibilities: 100% onsite required. Perform experiments using the following methodologies: PCR, RT-qPCR, flow cytometry, mammalian cell culture, Luminex, MSD, and ELISA. With moderate supervision design and execute analytical experiments of moderate complexity. Perform data analysis, summarize and report experimental results. Document/review laboratory work in notebooks that is detailed, accurate, timely, and in compliance with Good Lab Practices/Good Documentation Practices requirements. Collaborate with the Quality Control and Analytical Development teams to advance analytical and development projects. Ensure proper operation and perform routine maintenance of all laboratory equipment. Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment. Perform cell based in-vitro flow experiment, ELISA, qPCR to assess critical reagent concentration. Capable of handling complex issues and solving problems with only general guidance. Prepare and present continuous improvement projects to management. Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents. Complete all work in a timely manner. Perform peer review of testing data. Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner. Complete all reviews in accordance with required timelines. Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required. Participate in complex projects and continuous improvement efforts. Communicate effectively with management regarding task completion, roadblocks, and resource needs. Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles. Required Qualifications: Education And Experience: Required B.S. with 2 years' work experience or M.S. with 0 years' experience in Molecular & Cellular Biology, Immunology, or related discipline. Advanced hands-on experience with various analytical techniques including flow-cytometry, molecular techniques Scientific knowledge in the characterization and transfer of pharmaceutical products. Experience with PCR and/or flow cytometry and/or mammalian cell culture is required. Experience working in a regulated (GLP/GMP) environment in preferred. Assay development, especially cell-based potency assays are preferred. Assay qualification/validation experience is preferred. Assay Technology Transfer (TT) experience is preferred. Excellent organization skills and ability to handle multiple tasks Highly motivated, willingness to acquire new skills, and ability to work with minimal supervision. Excellent verbal and written communication skills. Advanced problem-solving ability/mentality, technically adept and logical thinking. Ability to represent the interests of the group on cross-functional teams. Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Ability to work with management locally and globally. Advanced ability to communicate effectively with peers, department management and cross-functional peers. Pay Rate: $49.13-$52.11/Hour If hired, you will enjoy the following ECLARO Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO If interested, you may contact: June Binuya junethel.binuya@eclaro.com 2128047476 June Binuya | LinkedIn Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

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. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Electrical Factory Inspector (Remote/Travel) responsibilities include, but are not limited to, the following: • Support department objectives and company goals, • Be a team player, • Sustain a positive, enthusiastic and professional attitude at all times, • Accommodate requests with a smile and “let me see what I can do” attitude, • Adhere to manager directives, • Maintain a professional appearance and demeanor, • Arrive on time, properly dressed and prepared to work, • Perform all duties in a timely, accurate, honest and professional manner, • Communicate with customers professionally and in accordance with customer service standards, • Be respectful to others Primary Tasks/Responsibilities: • Surveillance inspections of factories to assure products remain in compliance with conditions of granted certification., • Other duties assigned by management.Qualifications Basic Minimum Education Qualifications: • Two-year college degree or four-year college degree required Basic Minimum Qualifications: • Knowledge of electronics, • Certification in Electronics, ideal but not required, • Willing to travel - This position requires 90% - 100% travel, • Able to rent a car, • Willing to work overtime and remote, • Cannot be on any no fly list, • Clean driver record, • Authorization to work in the United States indefinitely without restriction or sponsorship. The Ideal Candidates Possesses the Following: • Ability to maintain confidentially, • Needs to be receptive to and accepting guidance from others, • Ability to deal with difficult people and problems, • Able to work well in a team environment, • Able to work in a diverse group of people, • Attention to detail, • Ability to multi-task and prioritize assignments, • Professional appearance Physical Qualifications: • Able to sit or stand for long periods of time, • Able to lift up to 30 pounds Additional Information Position is full-time travel & hybrid, working Monday - Friday 8:00 am to 5:00 pm, with overtime as needed. • Compensation: $50,000 - $70,000, • Excellent full-time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match, • Paid vacation and holidays Eurofins USA Consumer Product Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Job Description SOKOL GxP Services is seeking a motivated Cell Therapy Analytical Development (CTAD) Analyst to support analytical testing and method transfer activities within a fast-paced cell therapy environment. This role supports process characterization testing for lentiviral vector and cell therapy drug product samples and requires hands-on laboratory experience in regulated pharmaceutical or biotechnology settings. Requirements • Perform analytical experiments using methodologies such as PCR, RT-qPCR, flow cytometry, mammalian cell culture, ELISA, MSD, and Luminex, • Execute GLP analytical testing to support process characterization activities, • Support analytical method transfer and assay execution with moderate supervision, • Analyze, summarize, and report experimental data accurately and compliantly, • Maintain laboratory documentation in accordance with GLP/GDP requirements, • Collaborate cross-functionally with Analytical Development and Quality teams, • Support assay qualification/validation and analytical troubleshooting activities, • Ensure proper operation and routine maintenance of laboratory equipment, • Participate in continuous improvement initiatives and support investigation activities as neededRequired Qualifications, • Bachelor’s degree in Molecular Biology, Cell Biology, Immunology, or related scientific discipline, • Minimum 2 years of laboratory experience in pharmaceutical, biotechnology, or cell therapy environments, • Hands-on experience with PCR and/or flow cytometry and/or mammalian cell culture, • Experience working in a GLP/GMP-regulated environment, • Strong scientific, analytical, and organizational skills, • Ability to work independently and manage multiple priorities in a fast-paced environment, • Strong written and verbal communication skillsPreferred Qualifications, • Experience with assay development or assay qualification/validation, • Cell-based potency assay experience, • Experience supporting analytical technology transfer activities, • Familiarity with lentiviral vector or cell therapy products Benefits Competitive hourly rate: $44.50 – $48.10/hr (W-2 only, no C2C) Working Hours: Monday - Friday, regular business hours 12-month contract with possible extension Health insurance, holiday pay, 401(k) program, and other benefits Employee referral bonus program

Job Description About the Role: The Medical Technologist plays a critical role in the healthcare system by performing complex laboratory tests that aid in the diagnosis, treatment, and prevention of diseases. This position requires meticulous attention to detail to ensure the accuracy and reliability of test results, which directly impact patient care decisions. The Medical Technologist operates and maintains sophisticated laboratory equipment, analyzes biological specimens, and interprets data to provide actionable insights to physicians and healthcare providers. Collaboration with clinical staff and adherence to regulatory standards are essential to maintain laboratory quality and safety. Ultimately, this role contributes to improving patient outcomes through precise laboratory diagnostics and continuous quality improvement initiatives. Minimum Qualifications: • Bachelor’s degree in Medical Technology, Clinical Laboratory Science, or a related field from an accredited institution., • Certification as a Medical Technologist (MT) or Clinical Laboratory Scientist (CLS) by a recognized certifying body such as ASCP or AMT., • At least one year of experience working in a clinical laboratory setting performing diagnostic testing., • Strong knowledge of laboratory safety protocols and regulatory compliance requirements., • Ability to accurately perform and interpret complex laboratory tests with attention to detail. Preferred Qualifications: • Advanced certification or specialization in areas such as microbiology, hematology, or molecular diagnostics., • Experience with laboratory information systems (LIS) and electronic medical records (EMR) integration., • Familiarity with quality management systems and participation in proficiency testing programs., • Previous experience working in a hospital or high-volume clinical laboratory environment., • Graduate coursework or continuing education in emerging diagnostic technologies and laboratory management. Responsibilities: • Perform routine and specialized laboratory tests on blood, tissue, and other body fluids using automated and manual techniques., • Operate, calibrate, and maintain laboratory instruments and equipment to ensure optimal performance and compliance with safety standards., • Analyze test results, identify abnormalities, and report findings accurately and promptly to healthcare providers., • Maintain detailed records of tests performed, quality control procedures, and equipment maintenance logs., • Collaborate with medical staff to troubleshoot technical issues and provide expert guidance on laboratory procedures., • Ensure compliance with all regulatory requirements, including OSHA, CLIA, and CAP standards., • Participate in continuous education and training to stay current with advancements in laboratory technology and methodologies. Skills: The Medical Technologist utilizes strong analytical skills daily to conduct and interpret a wide range of laboratory tests accurately. Attention to detail is critical when calibrating instruments and reviewing test results to ensure data integrity and patient safety. Effective communication skills are essential for collaborating with healthcare professionals and documenting findings clearly. Technical proficiency with laboratory equipment and software systems supports efficient workflow and compliance with regulatory standards. Additionally, problem-solving skills enable the technologist to troubleshoot equipment issues and optimize laboratory processes for improved diagnostic outcomes. Evening/Overnight Tuesday-Saturday 8 hours/80 hours

Job Description Molecular Technologist Full-Time | Overnight Shift | Union, NJ 07083 Location: Union, NJ 07083 (In-Person) Pay: $35.00 – $38.00 per hour Schedule: Monday – Friday, 11:00 PM – 7:00 AM Department: Molecular Diagnostics Status: Full-Time About the Role We are seeking a skilled and detail-driven Molecular Technologist to join our overnight laboratory team in Union, NJ. In this role, you'll perform complex molecular diagnostic testing — including PCR, nucleic acid extraction, and sequence analysis — that directly supports accurate, timely patient diagnoses. This overnight position is critical to keeping our lab's turnaround times fast and our quality standards high around the clock. If you have a strong molecular biology background, thrive in a fast-paced lab environment, and take pride in precision work, we'd love to have you on our team. What You'll Do • Perform molecular diagnostic testing, including PCR, RT-PCR, nucleic acid extraction, and amplification, • Accurately prepare, process, and analyze patient specimens following established protocols and SOPs, • Operate, calibrate, and maintain molecular testing equipment and instrumentation, • Interpret and validate test results, escalating abnormal or unclear findings appropriately, • Document testing data, QC results, and patient information accurately in the laboratory information system (LIS), • Perform and monitor quality control and quality assurance procedures to ensure testing accuracy, • Troubleshoot instrument and assay issues, escalating to supervisors or technical support as needed, • Maintain a clean, organized, and safety-compliant overnight laboratory environment, • Adhere to CLIA, CAP, and all applicable regulatory and laboratory safety standards, • Communicate effectively with day-shift staff to ensure seamless handoff and continuity of testing What We're Looking For Required • Bachelor's Degree in Molecular Biology, Clinical Laboratory Science, Medical Technology, or a related field, • Relevant clinical laboratory certification (ASCP, AMT, or equivalent) preferred, • Hands-on experience with PCR, molecular assays, and nucleic acid testing methods, • Strong understanding of laboratory quality control, CLIA, and CAP compliance standards, • Excellent attention to detail and ability to work independently during overnight hours, • Strong documentation and data entry skills, • Ability to work Monday–Friday, 11:00 PM – 7:00 AM consistently You'll Stand Out If You Have • Experience in a high-volume diagnostic or reference laboratory setting, • Familiarity with next-generation sequencing (NGS) or other advanced molecular platforms, • Prior overnight or off-shift laboratory experience, • A track record of strong problem-solving under time-sensitive conditions Why Join Our Team • Competitive overnight pay: $35.00–$38.00 per hour, • Consistent Monday–Friday schedule — your weekends stay free, • Work with advanced molecular technology in a modern diagnostic lab, • Collaborative, knowledgeable team committed to diagnostic excellence, • Opportunities for growth and continued professional development How to Apply Please submit your resume along with a brief note about your molecular testing experience and certifications. We review applications promptly and look forward to connecting with qualified candidates. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, n Company DescriptionLincoln Reference Laboratory is one of the largest independent, general diagnostic laboratories, located in Union NJ. We take pride in delivering quality service since 2004 for a broad range of medical diagnostic testing in our new and advanced facility. We cover industry leading medical testing in Molecular Oncology, Hematology, Histopathology, and Chemistry. Excellence and specificity of patient testing is our highest priority! Our facility in New Jersey provides an array of services in molecular oncology, diagnostic blood testing, toxicology, GI testing, RPP, Urovysion Fish, H.Pylori breath test, and so much more. All testing is done in-house, which increases turnaround time. Looking at the patient’s susceptibility to illness on a genetic level provides physicians with greater insight into improving patient care. Our state-of-the-art instrumentation and highly skilled and licensed technologists provide quality results and consultation. For many years our experienced pathologists offer their expertise in the oversight of diagnostic cases from all tissue specimens. We provide a full range of histology services, including grossing, processing, embedding, microtome, routine, and special staining. We ensure properly prepared tissues and slides to provide accurate diagnoses. We are highly experienced technologists, who are registered and licensed by NY and other states in US. We use latest, state-of-the-art, medical equipment and instrumentation in the preparation of specimens, and we guarantee strictest quality assurance mechanisms are implemented to maintain consistency and precision. For all our client’s convenience, we offer a web-based reporting tool to get testing results. You can now securely access results virtually anywhere and at any time. At Lincoln Diagnostics LLC, we can guarantee fast responses to your concerns and immediate action should you wish to receive them. Certifications National Women Business Owners Corporation (NWBOC)Lincoln Reference Laboratory is one of the largest independent, general diagnostic laboratories, located in Union NJ. We take pride in delivering quality service since 2004 for a broad range of medical diagnostic testing in our new and advanced facility. We cover industry leading medical testing in Molecular Oncology, Hematology, Histopathology, and Chemistry. Excellence and specificity of patient testing is our highest priority!\r\n\r\nOur facility in New Jersey provides an array of services in molecular oncology, diagnostic blood testing, toxicology, GI testing, RPP, Urovysion Fish, H.Pylori breath test, and so much more. All testing is done in-house, which increases turnaround time. Looking at the patient’s susceptibility to illness on a genetic level provides physicians with greater insight into improving patient care.\r\n\r\nOur state-of-the-art instrumentation and highly skilled and licensed technologists provide quality results and consultation. For many years our experienced pathologists offer their expertise in the oversight of diagnostic cases from all tissue specimens. We provide a full range of histology services, including grossing, processing, embedding, microtome, routine, and special staining. We ensure properly prepared tissues and slides to provide accurate diagnoses.\r\n\r\nWe are highly experienced technologists, who are registered and licensed by NY and other states in US. We use latest, state-of-the-art, medical equipment and instrumentation in the preparation of specimens, and we guarantee strictest quality assurance mechanisms are implemented to maintain consistency and precision.\r\n\r\nFor all our client’s convenience, we offer a web-based reporting tool to get testing results. You can now securely access results virtually anywhere and at any time. At Lincoln Diagnostics LLC, we can guarantee fast responses to your concerns and immediate action should you wish to receive them.\r\n\r\nCertifications\r\nNational Women Business Owners Corporation (NWBOC)

CLIA-approved, NYS-licensed, and Joint Commission and CAP-accredited Anatomic Pathology facility that includes Molecular Genetics, FISH and Flow Cytometry testing. Uses Infection Control practices and procedures including, but not limited to, wearing gloves, goggles, protective masks and other safet

Our partner labs are building models that need to reason about theoretical physics, condensed matter, quantum information, particle physics and high-energy theory, astrophysics and cosmology, atomic/molecular/optical (AMO) physics, plasma physics, biophysics, statistical and computational physics, a

Provide structured feedback on AI accuracy in areas such as molecular biology techniques, genomics and proteomics standards, regulatory guidelines for research (GLP, IRB requirements), and scientific literature interpretation\n \n- Collaborate asynchronously with research teams to refine evaluation

Job Description Principal Scientist, Drug Discovery in our Research and Development Department responsible for identifying new molecular entities and technologies for animal health from our laboratories or external partners.

Job Description The Principal Scientist, Drug Discovery in our Research and Development Department will be responsible for identifying new molecular entities and technologies for use in animal health from our Company Laboratories or from external partners such as human pharma or biotech companies a

New Graduate Nuclear Medicine Scientist - Western Australia Structured Graduate Program with dedicated mentorship and training, exposure to multiple clinics and diverse patient presentations, and career pathways into advanced molecular imaging and leadership opportunities. Why Qscan Group? Qscan Gro

Biologics Process Research & Development Organization Within our company’s Research Laboratories, the Biologics Process Research & Development organization is responsible for developing the drug substance manufacturing processes for our biologics pipeline. We work closely with colleagues in Discovery, Pre‑clinical, and Early Development to rapidly develop manufacturing processes for biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and implementation of new manufacturing technologies, working with the Manufacturing Division to commercialize and launch new products. Position Summary We are seeking a highly motivated and energetic individual to join our Biologics Process Development Department as an Associate Principal Scientist. The successful candidate will work closely with a highly motivated team of scientists and engineers in the Upstream Process Development area and contribute to CMC development of our pipeline. They will play an active role in designing, developing, and optimizing cell culture processes and transferring processes to clinical and commercial manufacturing sites, and participate in technology development initiatives for assets in early and late‑stage clinical development. Responsibilities Lead or participate in upstream process development of first‑in‑human and commercial processes, efficiently developing high‑yield, robust, and scalable cell culture processes. Oversee process development, process characterization, and regulatory filing activities to ensure a clear path to successful PPQs and BLAs. Partner with colleagues in Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that achieve Quality by Design targets with robust control strategies. Advance the upstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs. Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies. Keep up to date with the external patent and literature environment; actively present and publish externally and pursue patenting strategies. Required Qualifications Ph.D. with 4+ years of experience OR Master’s with 8+ years of experience OR bachelor’s with 12 years of experience in chemical engineering, bioengineering, biological engineering, or a related field. Technical background and hands‑on experience with mammalian cell culture and fed‑batch processes to produce recombinant proteins. Scientific understanding and working knowledge of CHO cell biology, metabolism, cell culture media, and engineering principles for large‑scale recombinant protein production systems. Working knowledge of statistical methods (Design of Experiments, multivariate data analysis) and tools (SIMCA, JMP, etc.). Understanding of cell culture bioreactors including microbioreactors, bench‑scale and pilot‑scale bioreactors, and bioreactor scale‑up principles from laboratory to large scale. Proven track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation record. Ability to plan, execute, analyze, and document all stages of cell culture process development and communicate complex data in a highly organized manner. Excellent verbal, written, and interpersonal communication skills and ability to work effectively in a cross‑functional, matrixed team environment. Demonstrated initiative, creativity, and innovation in problem‑solving, productivity, and efficiency in the laboratory. Ability to deliver complex objectives under aggressive timelines. Preferred Qualifications Experience with cell culture media development. Experience with high‑throughput microbioreactor systems and advanced in‑situ analytics for process monitoring and control. Experience with state‑of‑the‑art cell culture processes, including intensified inoculum/fed‑batch and perfusion process development. Background in data science approaches related to cell culture and predictive modeling (e.g., metabolic flux analysis, omics, machine learning, computational fluid dynamics) and experience integrating PAT efforts. Experience with late‑stage commercial process development, technology transfer, scale‑down model qualification, and process characterization. Knowledge of biologics CMC development cycle and scale‑up/down in addition to tech transfer to GMP manufacturing sites. Required Skills Biodesign, Biological Engineering, Cell Cultures, Cell Line Development, Cell Physiology, Chemical Engineering, Clinical Trials, Computational Fluid Dynamics (CFD), Detail‑Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Interpersonal Relationships, Leading Project Teams, Mammalian Cell, Mammalian Cell Culture, Manufacturing Processes, Molecular Biology, Operational Efficiency, Pharmaceutical Formulations, Pharmaceutical Process Development, Physical Characterization, Stable Cell Lines. Equal Employment Opportunity Statement We are committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. If you need an accommodation during the application or hiring process, please let us know. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights EEOC GINA Supplement. Salary and Benefits The salary range for this role is $142,400.00 – $224,100.00. The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits including medical, dental, vision, healthcare and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. #J-18808-Ljbffr

A full-service provider, we provides Sanger DNA sequencing, gene synthesis, molecular biology, high throughput/next generation sequencing, bioinformatics, and GLP regulatory services. As a global leader in R&D genomics services, GENEWIZ, leads the way in providing superior data quality with unparall

Qscan Group is offering an exciting opportunity for a Graduate Nuclear Medicine Scientist in the United States.This structured graduate program includes dedicated mentorship, exposure to multiple clinics, and pathways into advanced molecular imaging and leadership.You will perform Nuclear Medicine e

Rutgers University in Newark is seeking a Research Assistant to support the Center for Molecular & Behavioral Neuroscience. The role involves recruiting participants for studies, maintaining lab space, and assisting with experiments under the Principal Investigator's guidance. The ideal candidate mu

Position Summary We are seeking a highly motivated and experienced Associate Principal Scientist to join our Cell Line Development group. The successful candidate will provide scientific and technical leadership for late‑stage biologics programs with a focus on cell line development and cell banking‑related regulatory strategy, filing authoring, and health authority response support. The ideal candidate will have strong hands‑on and strategic experience with mammalian cell line development, late‑stage CMC program support, regulatory filing authoring, and limit of in‑vitro cell age (LIVCA) studies. The candidate will ensure that cell line development and cell bank characterization data packages are scientifically sound and suitable to support global regulatory submissions, serving as a key interface between Cell Line Development, Regulatory CMC, and cross‑functional CMC program teams. Key Responsibilities Lead and support cell line development and cell bank characterization activities for late‑stage biologics programs. Design and execute pre‑LIVCA studies, coordinate LIVCA campaigns, and generate genetic stability data packages to support the establishment of a control strategy for commercial manufacturing processes. Partner with upstream, downstream, analytical, and manufacturing teams. Author, review, and provide technical input for CLD‑related sections of regulatory submissions, including IND, IMPD, BLA, and MAA submissions, and responses to global regulatory agencies. Serve as the CLD representative on cross‑functional CMC teams and partner closely with Regulatory CMC to develop scientifically robust filing strategies. Support responses to health authority questions (RTQs) related to cell line development, cell banking, clonality, genetic stability, LIVCA, and related control strategy topics. Author technical reports, source documents, risk assessments, and knowledge‑management content related to cell line development. Support digitization efforts to streamline authoring and report writing. Maintain awareness of relevant regulatory expectations, industry practices, and scientific developments related to cell line development, cell bank characterization, and LIVCA. Required Qualifications Ph.D. in Biology, Cell Biology, Molecular Biology, Biochemistry, Biotechnology, Chemical/Biochemical Engineering, or a related discipline with 4+ years of industry experience; or Master’s degree with 8+ years of industry experience. Strong experience in mammalian cell line development, preferably using CHO‑based expression systems for therapeutic proteins or monoclonal antibodies. Working knowledge of ICH guidelines and regulatory expectations relevant to biotechnology‑derived products, cell substrates, cell banking, and genetic stability. Demonstrated experience supporting late‑stage biologics programs, including pre‑LIVCA studies to generate both phenotypic and genotypic stability data packages. Experience authoring CLD‑related regulatory submissions and supporting responses to health authority questions in collaboration with Regulatory CMC teams and cross‑functional CMC development teams. Strong scientific writing and communication skills, with the ability to develop clear, accurate, and well‑structured technical and regulatory documents. Strong understanding of cell line history, clone selection, clonality, cell substrate characterization, cell bank generation & testing, genetic stability, and LIVCA. Ability to work independently, manage multiple priorities, and influence cross‑functional teams effectively. Preferred Qualifications Experience supporting global regulatory submissions across major markets, including the United States, Europe, Japan, and China. Experience in upstream commercial process development for biologics programs. Hands‑on experience with cell line genetic characterization techniques including RNAseq, PCR, Southern and Northern blotting. Experience preparing technical source documents, regulatory summaries, RTQs, and agency briefing materials. Experience across early and late‑stage biologics development, with an ability to connect CLD decisions into long‑term regulatory and commercial strategy. Salary and Benefits The salary range for this role is $142,400.00 - $224,100.00. Eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, healthcare insurance for employee and family, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr

Overview Rutgers, The State University of New Jersey (Rutgers University), is seeking a Postdoctoral Associate in the Department of Microbiology, Biochemistry and Molecular Genetics of the New Jersey Medical School (NJMS). Equal Employment Opportunity Statement Rutgers University is an equal access/

Bristol-Myers Squibb is searching for a Senior Specialist in Quality Control Analytical Testing at their Summit, NJ facility.The role entails responsibilities in analytical testing during both clinical and commercial phases, including expertise in flow-cytometry, ELISA, and qPCR.The ideal candidate