Quality Control Bioanalytical Scientist
About Site
Catalent’s Princeton facility is a modern, collaborative environment dedicated to advancing pharmaceutical development and manufacturing. The site focuses on providing innovative solutions for oral and specialty drug products, supporting clients from early development through commercial supply. With state-of-the-art laboratories and technical spaces, the location fosters teamwork and scientific excellence, enabling employees to work on cutting-edge projects that make a real impact on patient health. This dynamic setting offers an engaging workplace where expertise and innovation come together to deliver high-quality solutions for global healthcare needs.
Position Summary
We have an opportunity for a Quality Control Scientist to join our team and support analytical and bio-analytical testing for cell therapy products, raw materials, and critical reagents in a GMP-regulated Quality Control laboratory. This role involves in-process, release, characterization, and stability testing for autologous and allogeneic cell therapy programs. You will generate, review, and interpret data to evaluate critical quality attributes such as identity, purity, potency, and safety. The position also supports method transfer, validation, troubleshooting, and continuous improvement activities, ensuring compliance with specifications and regulatory requirements.
Shift: Monday - Friday 8am-5pm
Location: Princeton, NJ
100% Onsite
The Role
- Perform routine and non-routine Quality Control testing to support cell therapy manufacturing, including in-process, release, characterization, stability, raw material, and investigational testing in accordance with approved methods, SOPs, specifications, and regulatory requirements.
- Execute and support cell therapy analytical methods, including flow cytometry-based identity, phenotype, purity, and characterization assays; ddPCR/qPCR-based molecular assays; ELISA or multiplex immunoassays; automated cell count and viability assays; potency or functional cell-based assays; osmolality; pH/conductivity; and applicable compendial or platform methods.
- Support testing for product-specific and platform critical quality attributes, including viable cell concentration, total cell dose, percent viability, identity marker expression, target cell population purity, residual or impurity-related attributes, potency, and applicable vector- or transgene-related readouts.
- Support method transfer, verification, qualification, and validation activities, including protocol execution, data analysis, discrepancy resolution, acceptance criteria assessment, and report generation.
- Analyze, trend, and interpret assay performance data to evaluate method reliability, sample results, system suitability, control performance, assay validity, and laboratory performance indicators.
- Perform investigations related to analytical deviations, assay failures, invalid runs, out-of-specification or out-of-trend results, and atypical assay trends; support root cause analysis, product impact assessment, corrective and preventive action development, and change control activities.
- Collaborate with Quality Assurance, Manufacturing, Process Development, Analytical Development, Regulatory Affairs, and client-facing teams to support product testing, method lifecycle management, technology transfer, manufacturing readiness, and technical issue resolution.
- Support analytical control strategies for cell therapy raw materials, in-process materials, drug substance/intermediate materials, drug product, and final product release testing.
- Review and document test results in compliance with SOPs, approved specifications, regulatory expectations, ALCOA+ data integrity principles, and good documentation practices.
- Support internal and external audits by providing analytical testing data, method documentation, investigation records, qualification/validation evidence, and laboratory compliance documentation.
- Maintain laboratory readiness through reagent management, reference/control material handling, logbook completion, inventory control, equipment cleaning, and other assigned laboratory duties.
The Candidate
Minimum Requirements
- Bachelor’s degree in Biochemistry, Analytical Chemistry, Molecular Biology, Microbiology or related field with 4+ years of relevant experience (Master’s degree preferred), or 10+ years of relevant experience in lieu of degree.
- Hands-on experience with cell therapy analytical methods, including flow cytometry, ddPCR/qPCR, automated cell count and viability, ELISA or multiplex immunoassays, potency or functional cell-based assays, molecular assays, cell culture, and applicable compendial or platform testing.
- Experience with analytical method transfer, verification, qualification, validation, troubleshooting, lifecycle management, and Good Manufacturing Practice implementation in a regulated environment.
- Familiarity with cell therapy Good Manufacturing Practice manufacturing support, aseptic sample handling, chain of custody/chain of identity considerations, stability testing, release testing, and client or regulatory expectations for advanced therapy products.
- Visual acuity requirements: minimum 20/20 vision with or without correction with both eyes using the Graham Field Eye Test Chart from 10 feet; ability to identify colors on the Ishihara Charts of Color Deficiency; if prescription changes during employment, a new visual acuity assessment is required to meet these standards.
Preferred Skills & Background
- Experience supporting testing for cell therapy critical quality attributes such as identity, purity, potency, viability, cell concentration, total cell dose, phenotype, residual impurities, and vector- or transgene-related attributes, as applicable.
- Knowledge of statistical analysis, assay trending, method performance monitoring, and scientific data interpretation.
- Familiarity with quality management systems, deviation/corrective and preventive action processes, change control, continuous improvement, and audit readiness in a regulated Quality Control laboratory.
Pay
The anticipated hourly rate for this position in NJ is $40.86 – $45.67 Plus Bonus. The final hourly rate offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why You Should Join Catalent
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- Competitive paid time off plus 8 paid holidays
- Community engagement and green initiatives
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
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Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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