Manager, Quality Control

Role: Manager, Quality Control at a biopharma company, overseeing HPLC and compendial testing for biologics in a GMP environment. Objectives: ensure timely QC testing, data review, method validation, and management of quality events. Responsibilities: perform and oversee analytical testing (HPLC, CE-SDS, ICP-MS), author/revise SOPs, develop protocols for assay transfers/validation, manage QC lab operations, and serve as SME for key techniques. Qualifications: Bachelor's degree, 7+ years in QC, with experience in gene therapy or biologics, especially GMP release testing, and expertise in HPLC, ICP-MS, and protein purity assays. Preferred: direct reports management, FDA-regulated environment experience, strong organizational skills. High-Value: biologics, gene therapy, GMP, QC release, HPLC, ICP-MS, CE-SDS, in-person based in San Diego, CA. Work setup: full-time, on-site.