Associate Director, Quality Control- Analytical Tech Services

Role: Associate Director leading the Quality Control Analytical Tech Services group at Kite, focused on supporting CAR-T cell therapy operations. Responsibilities include overseeing complex bioanalytical methods such as qPCR/ddPCR, flow cytometry, and cell-based bioassays, driving automation development, method validation, transfer, and troubleshooting; supporting lab investigations, deviations, CAPAs, and change controls; authoring technical reports; and mentoring staff. Collaborates extensively with QA, Analytical Development, Manufacturing, and Regulatory teams, ensuring compliance with GMP standards. Qualifications: Advanced degree (MD, PharmD, PhD) with 2+ years or relevant experience in biologics/cell-gene therapy QC Analytical/Development; or equivalent experience with a master’s or bachelor’s degree and more years. Preferred skills include proven management of analytical labs, deep GMP bioanalytical expertise, investigation experience, and regulatory knowledge (21 CFR). High-value biopharma specifics: focus on cell therapy, biologics, GMP compliance, QC validation, and assay automation within a fast-paced, innovative cancer immunotherapy environment. Work setup: based in Frederick, MD, with involvement in compliance and inspection activities.