Job Description

We are seeking a highly motivated Analytical Scientist with hands-on experience in method qualification and validation to support the development of targeted biologic therapies in oncology. 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 targeted antibody-based therapies. 

Key Responsibilities

• Develop, qualify, and validate analytical methods in accordance with ICH guidelines (Q2(R1)/Q14) to support 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 targeted antibody-based therapeutics

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, or related field with 2–10 years of industry experience; or M.S./B.S. with 5–10+ years of relevant experience.
• Direct experience with method qualification and validation for biologics
• Deep understanding of analytical techniques for protein and antibody fusion characterization. Specific experience with targeted immunotherapies, antibody fusions, ADC, and other related molecules a plus.
• 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 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 complex biologics for treatment of cancer
• High-impact role with visibility across CMC and regulatory strategy.
• Collaborative, science-driven team environment.

Job Tags

Similar Jobs