Senior Director, Analytical Development
Core
Define and execute analytical development strategies for biologics programs in a lean, virtual development and manufacturing model.
Role type
Senior Director, Analytical Development (Biologics)
Builds
Analytical operating models, control strategies, and external partner networks for protein therapeutics
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development, qualification, validation, lifecycle management, protein characterization, GMP compliance, regulatory submission support, CDMO management, budget management, team leadership
Preferred skills
Experience with monoclonal antibodies, recombinant proteins, fusion proteins, technology transfer, comparability assessments
Technologies
Chromatographic, electrophoretic, spectroscopic techniques
Responsibilities
Define long-term analytical strategy and governance, lead external testing operations, manage CDMO relationships, support regulatory submissions, lead high-impact technical investigations, manage departmental budgets
Seniority
Senior Director, strategic leadership with hands-on technical execution
