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