About this opportunity
Scorpion Therapeutics lists this Director Analytical Development opportunity in chesterbrook, Pennsylvania. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.