Director Analytical Development

Role: Director of Analytical Development leading late-stage biologics programs, with a focus on supporting Phase 3 clinical supply, process characterization, validation, regulatory submissions, and commercial readiness. Responsibilities: provide strategic leadership for analytical methods development, validation, transfer, characterization, stability, and control strategies; oversee external CROs/CDMOs; ensure analytical approaches support product quality attributes, comparability, and regulatory compliance; lead investigations of analytical issues; collaborate cross-functionally with Manufacturing, Quality, Regulatory, and Supply Chain to mitigate risks and meet program milestones. Requirements: Ph.D., M.S., or B.S. in relevant sciences; 10+ years in biopharma analytical development, especially with biologics such as monoclonal antibodies or recombinant proteins; extensive experience supporting late-stage development, regulatory filings (BLA/MAA), and commercialization; strong expertise in chromatographic, electrophoretic, mass spectrometry, and biological potency assays; proven external partner management and regulatory documentation skills. HighValue: biologics (mAbs, proteins), Phase 3, regulatory submissions, cGMP, analytical lifecycle management, stability, comparability, and process validation; experience with global CRO/CDMO oversight; travel up to 30%. WorkSetup: hybrid Chesterbrook, PA; minimum 2 days/week onsite.