Sr Analytical/QC scientist - ADC development

StradBio • Seattle, WA

6d

About The Position

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.

Requirements

• 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.

Nice To Haves

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

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree