Scientist, QC Analytical

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.

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.