Senior Analytical/QC Scientist - ADC Development
Location
United States
Posted
5 days ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
Senior Analytical/QC Scientist - ADC Development
StradBio
Role Description We are seeking a highly motivated Analytical Scientist with hands-on experience in method qualification and validation to support the development of antibody-drug conjugates (ADCs). This role will be responsible for designing, qualifying, and validating analytical methods to support process development, IND-enabling studies, and clinical programs. The ideal candidate brings strong technical expertise in biologics characterization with specific familiarity in ADC attributes such as drug-to-antibody ratio (DAR), aggregation, and free payload. - Develop, qualify, and validate analytical methods in accordance with ICH guidelines (Q2(R1)/Q14) to support ADC programs through clinical stages. - Execute method transfer activities to external CROs/CDMOs and provide oversight to ensure successful implementation and lifecycle management. - Design and author validation protocols, reports, and method lifecycle documentation for regulatory submissions (IND/IMPD). - Support release and stability testing strategies, including specification setting and trending of critical quality attributes (CQAs). - Investigate out-of-specification (OOS) and out-of-trend (OOT) results, driving root cause analysis and corrective actions. - Collaborate cross-functionally with process development, manufacturing, regulatory, and quality teams to ensure alignment on CMC strategy. - Contribute to analytical control strategy development, including identification of critical methods and validation requirements. - Evaluate and implement new analytical technologies to enhance characterization of complex ADC modalities. Qualifications - Ph.D. in Analytical Chemistry, Biochemistry, or related field with 5–15 years of industry experience; or M.S./B.S. with 10+ years of relevant experience. - Direct experience with method qualification and validation for biologics; ADC-specific experience required. - Deep understanding of analytical techniques for protein and ADC characterization (e.g., DAR determination, aggregation, charge variants). - Working knowledge of regulatory expectations for analytical methods (ICH Q2, Q6B, Q14, USP). - Experience working with external partners (CROs/CDMOs) and managing method transfers. - Strong technical writing skills with experience contributing to regulatory filings. - Ability to work in a fast-paced, collaborative startup or early-stage biotech environment. Preferred Experience - Familiarity with linker-payload stability, free drug quantitation, and bioanalytical interfaces. - Exposure to GMP environments and QC assay lifecycle management. Benefits - Opportunity to work on next-generation ADCs and complex biologics. - High-impact role with visibility across CMC and regulatory strategy. - Collaborative, science-driven team environment.
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