Director, Analytical Technical Operations
Core
Lead the Core Analytical Testing & Integrations organization to generate controlled, reproducible, filing-ready analytical data underpinning CMC development and Module 3 regulatory submissions for mRNA medicines.
Role type
Director, Analytical Technical Operations (Leadership)
Builds
Development analytical data, stability studies, and regulatory submission packages for mRNA therapeutics.
Domain
Biopharmaceuticals / mRNA / CMC / Analytical Chemistry
Required skills
Strategic planning, team leadership (30-50 scientists), non-GMP analytical testing oversight, regulatory data integrity, cross-functional collaboration, operational efficiency, digital workflow modernization, risk-based decision making.
Preferred skills
PhD in relevant discipline, multi-technology analytical testing leadership (mRNA/LNP/vaccines), broad technical fluency (separations, RNA, lipids, biophysics, molecular biology, sequencing, microbiology), method-performance monitoring, GMP handoff experience.
Technologies
Benchling, LabVantage LIMS, Generative AI tools, digital workflow platforms.
Responsibilities
Set strategy and execution standards for analytical testing; lead a team of 30-50 specialists; oversee non-GMP release and stability testing; ensure data quality for regulatory submissions; modernize digital workflows and LIMS; improve laboratory throughput and cost effectiveness; partner with QC on GMP testing; build high-performing organization through workforce planning and coaching.
Seniority
Director, strategic leadership with hands-on technical oversight