Sr Analytical/QC scientist - ADC development

Position Summary
We are seeking a highly motivated CMC focused Analytical Scientist with deep expertise in analytical method development, qualification, and validation, and a strong foundation in Quality Control to support antibody-drug conjugate (ADC) programs. This role will lead the design, execution, and lifecycle management of robust analytical methods to ensure product quality, support process development, and enable IND and clinical-stage programs.

This role requires demonstrated expertise in ADC-specific analytical challenges, including drug-to-antibody ration (DAR), aggregation, free payload quantification, and stability-indicating methods. Experience supporting CMC regulatory filings, assay control strategies, and management experience with external vendors is essential. A strong understanding of phase-appropriate analytical requirements and readiness for GMP environments is expected.

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.