Scientist, QC Analytical

Quality Control Bioanalytical Scientist

About Site

Catalents 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

• Bachelors degree in Biochemistry Analytical Chemistry Molecular Biology Microbiology or related field with 4 years of relevant experience (Masters 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 7000 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.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

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Required Experience:

IC