Tech Stack

Description

You will perform routine and non-routine QC testing within a GMP laboratory, including cell-based assays, in-process testing, and lot release testing. This role supports gene therapy clinical trials and requires adherence to cGMP guidelines.

Requirements

• BA/BS in Biochemistry, Cell Biology, or related science
• Minimum 2 years lab experience in QC testing, preferably in cGMP environment
• High proficiency in cell culture and cell-based assays
• Understanding of GxP regulations and industry testing requirements
• Proficiency in MS Word, Excel, and LIMS (preferred)

Responsibilities

• Perform routine/non-routine cell-based testing (q-PCR, ddPCR, cell culture, ELISA) on in-process, DS, DP release, and stability samples
• Participate in equipment validation, method transfer/qualification/validation, and critical reagent qualification
• Review/generate protocols, reports, and maintain standard operating procedures
• Train other analysts as required
• Actively communicate gaps to leadership and work in cross-functional teams