Analytical Sciences Associate
On-site · Morrisville, North Carolina, United States
Job Summary
Analytical Sciences Associate responsible for performing routine analytical testing to support GMP release, stability, and product characterization programs, including cell-based potency assays, molecular assays (ddPCR), and/or biochemical assays (ELISA, CE, HPLC, Western blot) with primary depth in at least one assay category. Will execute assays per SOPs under GMP documentation practices (ALCOA+), review data for accuracy/compliance, collaborate on method qualification/validation/transfer per ICH/USP/GMP, maintain lab readiness, support audits/regulatory inspections, and train/mentor analysts. Requires a Bachelor’s or Master’s in relevant life sciences and 3-8 years of Analytical Sciences experience with hands-on cell-based potency assays, molecular assays, or biochemical assays, plus strong attention to detail and cross-functional collaboration.
Required Qualifications
- Bachelor’s or Master’s degree in Molecular Biology, Cell Biology, Biochemistry, Biotechnology, or a related discipline
- 3-8 years of relevant experience in Analytical Sciences or QC environment in the biopharmaceutical or gene therapy industry
- Familiarity with GMP documentation practices, data integrity principles, and regulatory expectations for biologics or gene therapy products
- Strong attention to detail, organizational skills, and ability to execute protocol-driven workflows in a regulated environment
- Effective communication and ability to work collaboratively in cross-functional GMP teams
- Hands-on experience in at least one of the following areas required, with working knowledge or exposure to others preferred: Cell-based potency assays, Molecular assays, or Biochemical assays (ELISA, CE, HPLC, Western blot)
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