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.

• 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.

• 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.

High Value: 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%.

Work Setup: hybrid Chesterbrook, PA; minimum 2 days/week onsite.