Scientist, QC Analytical

Catalent Pharma Solutions•Princeton, NJ

2d•$41 - $46•Onsite

About The Position

Catalent’s Princeton facility is a collaborative pharmaceutical development and manufacturing site supporting oral and specialty drug products from early development through commercial supply. This role supports analytical and bioanalytical testing for cell therapy products, raw materials, and critical reagents in a GMP-regulated Quality Control laboratory. Testing covers in-process, release, characterization, and stability activities for autologous and allogeneic cell therapy programs. The scientist generates, reviews, and interprets data for critical quality attributes including identity, purity, potency, and safety, and supports method transfer, validation, troubleshooting, and continuous improvement to ensure compliance with specifications and regulatory requirements. The position is Monday through Friday, 8:00 a.m. to 5:00 p.m., and is 100% onsite in Princeton, New Jersey. Work includes routine and non-routine laboratory testing, method lifecycle activities, data review and investigations, cross-functional collaboration, audit support, and maintenance of laboratory readiness.

Requirements

Bachelor’s degree in Biochemistry, Analytical Chemistry, Molecular Biology, Microbiology, or a related field with at least 4 years of relevant experience; alternatively, at least 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, and ability to identify colors on Ishihara Charts of Color Deficiency; a new visual acuity assessment is required if the employee’s 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 Quality Control testing supporting cell therapy manufacturing, including in-process, release, characterization, stability, raw material, and investigational testing under approved methods, SOPs, specifications, and regulatory requirements.
Execute and support 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 of 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, 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.
Investigate 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.
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.