Sr Analytical/QC scientist - ADC development

Position Summary 
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. 

Key Responsibilities 

• 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. 

What We Offer 

• 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.