Scientist, Potency Assay Development

Scientist, Potency Assay DevelopmentW2 Contract 12 MonthsSan Diego, CA 92130$37/hr + BenefitsWe are seeking a hands-on Analytical Development Scientist to support biologics programs, including AAV-based gene therapies and monoclonal antibodies (mAbs). This role focuses on developing, optimizing, and troubleshooting cell-based functional potency assays, along with molecular and biochemical methods.The ideal candidate has strong laboratory experience, enjoys solving technical challenges, and can collaborate with cross-functional teams to develop reliable analytical methods that support therapeutic development.Key ResponsibilitiesDevelop, optimize, and troubleshoot cell-based potency assays, particularly for AAV-based gene therapies.Design experiments measuring viral transduction, transgene expression, biological activity, and mechanism-of-action (MOA) endpoints.Investigate assay variability and improve accuracy, robustness, and reproducibility.Perform analytical testing, interpret data, and maintain accurate experimental records.Collaborate with internal QC teams and external CDMOs on method development, qualification, validation, and transfer.Prepare SOPs, technical reports, analytical procedures, and method transfer documentation.Support assay comparability assessments and analytical control strategies.Required QualificationsPhD in Molecular Biology, Cell Biology, Virology, Biochemistry, or related field; OR MS with 3+ years; OR BS with 5+ years of relevant industry experience.Hands-on experience developing, optimizing, and troubleshooting cell-based potency assays.Strong mammalian cell culture experience, including aseptic techniques, cryopreservation, and cell banking.Experience with one or more of the following:Cell-based functional potency, transduction/infectivity, or protein expression assays.qPCR, ddPCR, or RT-qPCR.Flow cytometry or cell-based imaging.ELISA, Western blotting, capillary electrophoresis, or MSD assays.Strong analytical, problem-solving, communication, and collaboration skills.Preferred QualificationsAAV gene therapy potency assay development, including MOA-based functional assays.Knowledge of AAV biology, transduction mechanisms, and transgene expression.Experience with monoclonal antibody or other biologics potency assays.Familiarity with analytical method qualification/validation, ICH Q2(R2), and method transfer to QC labs or CDMOs.Knowledge of LC-MS/MS or chromatographic techniques.