Scientist, QC Analytical

Catalent • Princeton, NJ

15h • Onsite

About The Position

Catalent’s Princeton facility is a modern, collaborative site supporting pharmaceutical development and manufacturing, with laboratories and technical spaces dedicated to oral and specialty drug products. The Quality Control Scientist supports analytical and bio-analytical testing for cell therapy products, raw materials, and critical reagents in a GMP-regulated Quality Control laboratory. The work covers autologous and allogeneic cell therapy programs and includes in-process, release, characterization, and stability testing. The scientist generates, reviews, and interprets data to evaluate product critical quality attributes, and supports method transfer, validation, troubleshooting, and continuous improvement while ensuring compliance with specifications and regulatory requirements.

This is a Monday–Friday, 8:00 a.m.–5:00 p.m. position located 100% onsite in Princeton, New Jersey. The anticipated hourly rate is $40.86–$45.67, plus bonus; the final rate may vary based on experience, skills, education, and business needs.

Requirements

• Bachelor’s degree in Biochemistry, Analytical Chemistry, Molecular Biology, Microbiology, or a related field and 4+ years of relevant experience; alternatively, 10+ years of relevant experience in lieu of a 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 GMP 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.
• Minimum 20/20 vision with or without correction in both eyes, assessed using the Graham Field Eye Test Chart from 10 feet; ability to identify colors on Ishihara Charts of Color Deficiency. A new visual acuity assessment is required if prescription changes during employment.

Nice To Haves

• Master’s degree.
• 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.

Responsibilities

• Perform routine and non-routine QC testing supporting cell therapy manufacturing, including in-process, release, characterization, stability, raw material, and investigational testing according to approved methods, SOPs, specifications, and regulatory requirements.
• Execute and support cell therapy analytical methods, including flow cytometry, ddPCR/qPCR, 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, 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 by executing protocols, analyzing data, resolving discrepancies, assessing acceptance criteria, and generating reports.
• Analyze, trend, and interpret assay performance data to evaluate method reliability, sample results, system suitability, control performance, assay validity, and laboratory performance indicators.
• Investigate analytical deviations, assay failures, invalid runs, out-of-specification or out-of-trend results, and atypical trends; support root cause analysis, product impact assessment, corrective and preventive actions, and change control.
• Collaborate with Quality Assurance, Manufacturing, Process Development, Analytical Development, Regulatory Affairs, and client-facing teams on 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.

Benefits

• Competitive paid time off and 8 paid holidays.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.
• Potential for career growth and a defined career path with annual performance review and feedback.
• Bonus potential.
• Diverse, inclusive culture and community engagement and green initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level