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Director Analytical Development
Job in
Seattle, King County, Washington, 98127, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Director of Analytical Development, Analytical Development and Quality Control (ADQC), leading strategic and technical efforts for biologics programs from early development through commercialization.
Responsibilities- oversee analytical control strategies, method development, validation, transfer, lifecycle management, and ensure analytical readiness for late-stage and commercial phases
- perform hands-on laboratory work
- troubleshoot and optimize methods
- manage reference standard and critical reagent programs
- author regulatory CMC sections
- scale capabilities, oversee equipment qualification, and implement workflows
- Collaborate with QC, QA, process development, manufacturing, regulatory affairs, and external partners to ensure compliance with cGMP, ICH, USP, and industry standards
- ensure inspection readiness
- lead external analytical activities and manage external partnerships
- PhD preferred in Biochemistry, Biophysics, or related field
- 8+ years in biopharma, including 4+ years in management within biologics analytical development
- expertise in A280, HPLC, CE, LC-MS, ELISA, cell-based potency
- strong understanding of analytical strategies, validation, transfer, and regulatory guidelines
- proven success supporting regulatory submissions and managing outsourcing
biologics, late-stage development, BLA/MAA submissions, cGMP compliance, analytical method lifecycle, hands-on laboratory expertise.
Work Setupremote; travel not typical.
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