Tech Stack

Description

You will perform routine and non-routine QC testing of gene therapy products in a GMP laboratory, including in-process, release, and stability testing using analytical methods such as q-PCR, HPLC, ELISA, and Western Blot. You will also support quality systems like deviations, CAPAs, and investigations, and participate in method transfers and validations.

Requirements

• BA/BS in Chemistry, Biochemistry, or related science
• 2-5+ years (Analyst II) or 5-8+ years (Analyst III) lab experience in QC testing, preferably in cGMP environment
• High proficiency in HPLC methods and analysis, and other analytical methods
• Computer literacy: MS Word, Excel, LIMS
• Effective communication, organizational, and critical thinking skills

Responsibilities

• Perform routine/non-routine QC testing and review of in-process, DS, DP release and stability samples
• Execute analytical methods including q-PCR, HPLC (SEC, IEX, rpHPLC), ELISA, RI, HIAC, DLS, Osmolality, Western Blot, CE-SDS
• Peer review assay data as SME with minimal errors
• Participate in equipment validation, method transfer/qualification/validation, and critical reagent qualification
• Support quality systems: deviations, CAPAs, investigations, OOS, OOT, change controls