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.

• 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.

• 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.

• Familiarity with linker‑payload stability, free drug quantitation, and bioanalytical interfaces.
• Exposure to GMP environments and QC assay lifecycle management.

• 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.