Sr Director, Analytical Operations
Core
Leading analytical development activities for protein-based biologics, including structural characterization, comparability strategies, and control of critical quality attributes.
Role type
Senior Director, Analytical Operations (People Leader)
Builds
Robust control strategies and regulatory filings for late-stage biologics portfolio
Domain
Biopharmaceuticals / Biologics / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development, Mass spectrometry, Biophysical techniques, Separation methods, Regulatory documentation (IND/BLA/PAS), Budget management, Team leadership, cGMP practices, CQA definition, Method bridging
Preferred skills
High throughput assay methodologies, Automation, Data governance, Strategic vision, Cross-functional collaboration
Technologies
Mass spectrometry, Biophysical techniques, Separation methods
Responsibilities
Lead a team of ~20 scientists, Oversee capital equipment budgeting, Define and implement analytical comparability strategies, Guide regulatory CMC section authoring, Establish state-of-the-art analytical laboratory, Recruit and mentor talent
Seniority
Senior Director, People Leader
