Associate Director, Quality Control- Analytical Tech Services
Core
Lead the Quality Control Analytical Tech Services group to support commercial operations in CAR-T technology, focusing on complex projects involving qPCR/ddPCR, Flow cytometry, and cell-based bioassays.
Role type
Senior IC/Lead Quality Control Manager (Analytical Tech Services)
Builds
Analytical assays, validation protocols, and automated testing workflows for CAR-T cell therapies
Domain
Biopharmaceuticals / Cell and Gene Therapy / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
qPCR, ddPCR, Flow cytometry, cell-based bioassays, method validation, method transfer, GMP compliance, CAPA, root cause analysis, LIMS integration, SOP development, technical reporting
Preferred skills
Supervising/managing analytical labs, bioanalytical methods under GMP, US/EU/ROW regulatory standards, change control, quality systems (21 CFR Part 11/210/211), GLP
Technologies
qPCR, ddPCR, Flow cytometry, LIMS
Responsibilities
Lead method validation and transfers; support laboratory investigations and deviations; establish data analytics for trend monitoring; author technical reports and protocols; supervise and mentor junior staff; create and revise SOPs; support equipment lifecycle and LIMS development; participate in compliance audits and inspection readiness; advise on technology purchases and implementation
Seniority
Senior, hands-on IC with leadership responsibilities
