Scientist I

The Scientist I, Quality Control performs GMP testing in support of viral vector manufacturing, release, and stability programs. The role focuses primarily on cell-based potency and infectivity assays and routine mammalian cell culture.

Primary Responsibilities:

• Independently perform cell-based potency, infectivity, transduction, and other functional assays for viral vector products and enter data in LIMS.
• Maintain mammalian cell cultures, including passaging, cell counting, viability assessment, and cryopreservation.
• Prepare samples, standards, controls, reagents, and media according to approved procedures.
• Execute testing in accordance with approved methods, SOPs, GMP, GDP, and data integrity requirements.
• Review and document assay results against established system suitability and acceptance criteria.
• Operate and maintain laboratory equipment such as biosafety cabinets, incubators, plate readers, microscopes, and automated cell counters.
• Support assay troubleshooting and method qualification/validation activities.
• Participate in deviations, OOS/OOT investigations, CAPAs, and continuous improvement activities.
• Maintain accurate and contemporaneous laboratory documentation.
• Collaborate with Analytical Development, Manufacturing, and Quality Assurance teams.
• Follow applicable safety and biosafety procedures when handling viral vectors and biological materials.

Education, Experience, & Qualification:

• Bachelor’s degree in biology, Cell Biology, Molecular Biology, Biochemistry, Biotechnology, or a related discipline.
• PhD with 0-2 years of experience or M.S. with 2-3 years of experience or B.S with 4-6 years of experience of relevant laboratory experience; experience in a GMP environment is preferred.
• Hands-on experience with mammalian cell culture and aseptic technique.
• Experience with potency, cell-based assays, plate-based assays, or flow cytometry.
• Familiarity with GMP, GDP, and data integrity principles is preferred.
• Preferred Experience: AAV and/or lentiviral vector testing, cell-based potency assays, qPCR/ddPCR, ELISA, flow cytometry, or other analytical methods commonly used in cell and gene therapy QC laboratories.