Job Location : Andover,MA, USA
We are seeking a Senior Gene Therapy QC Associate to support quality events, data trending, and analytical lab activities in a GMP-compliant environment.
Key Responsibilities:
Senior QC testing for bacterial plasmids, viral vectors, and reference materials
Perform assays (qPCR, ddPCR, JESS, Agarose Gel, Nanodrop UV/Vis)
Monitor, analyze, and trend QC data
Author/review SOPs, deviations, CAPAs, and Change Controls
Prepare and qualify standards for potency and titer assays
Qualifications:
B.S. in Molecular Biology, Cell Biology, or Virology (3–5 years experience)
Hands-on cGMP lab experience required
Expertise in PCR, electrophoresis, ELISA, spectrophotometry
Knowledge of USP, ICH, EP guidelines preferred
Strong documentation (GDP) and communication skills