Careers

Director / Associate Director, Biologics Analytical Development

Summary

The Associate Director/Director of Biologics Analytical Development will lead analytical activities supporting biologics and antibody–drug conjugate (ADC) programs from early discovery through late-stage clinical development and commercialization. This role will provide scientific leadership, strategic direction, and cross-functional collaboration to ensure robust analytical control strategies aligned with regulatory expectations. This role requires deep expertise in biologics analytical development, hands-on experience with ADCs, extensive experience working with CDMOs, and a proven track record of supporting IND, BLA, and global regulatory filings.

Key Responsibilities

• Lead phase-appropriate analytical development strategies for biologics and ADCs (including mAbs, drug substance, and drug product) across the product lifecycle.
• Design, oversee, and execute analytical method development, qualification, and validation to support IND-enabling through late-stage (Phase 3/BLA) programs.
• Serve as a subject matter expert in analytical characterization, release, stability, and comparability for biologics and ADCs.
• Establish and maintain analytical control strategies, including support for comparability assessments related to process changes, scale-up, and site transfers.
• Act as the analytical lead for CDMO engagements, providing scientific oversight of method development, validation, transfer, and routine testing activities.
• Manage and assess CDMO analytical performance, ensuring data quality, compliance, timelines, and effective issue resolution.
• Support method and technical transfer and ensure analytical readiness at CDMOs for clinical and commercial manufacturing.
• Author, review, and contribute analytical content to CMC sections of regulatory submissions (INDs, IMPDs, BLAs, MAAs).
• Lead responses to analytical regulatory inquiries and support health authority interactions, inspections, and audits.
• Partner cross-functionally with Process Development, Manufacturing, Quality, Regulatory, Clinical, and Supply Chain teams to ensure alignment and execution.
• Provide analytical governance across internal teams and external partners, including CDMOs and CROs.
• Drive scientific rigor, operational excellence, and consistent execution as a key contributor to overall CMC and portfolio strategy.

Key Skills and Experiences

• Detail-oriented with the ability to summarize complex issues Extensive experience in biologics analytical development, including hands-on or oversight experience with ADCs
• Demonstrated experience supporting both early-stage (preclinical/Phase 1) and late-stage (Phase 3/commercial) programs
• Proven experience working with CDMOs, including analytical oversight, method transfer, and issue resolution.
• Direct experience contributing to or leading global regulatory submissions
• Prior direct interaction with FDA, EMA, or other global health authorities
• Experience operating in a virtual or hybrid CMC development model
• Strong knowledge of analytical techniques used for biologics and ADCs, including:
  • Chromatography (HPLC/UPLC, SEC, HIC)
  • Electrophoresis (CE-SDS, icIEF)
  • Mass spectrometry
  • Binding and functional assays
• Solid understanding of ICH guidelines, analytical validation, comparability, and lifecycle management
• Strong leadership, communication, and stakeholder management skills
• Ability to influence and manage external partners without direct authority
• Strategic mindset with a willingness to remain technically engaged

Qualifications

• Associate Director:
  • PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 8–12+ years of relevant Biotech/Biologics industry experience
  • Masters in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 13-18+ years of relevant Biotech/Biologics industry experience
• Director:
  • PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 12–15+ years of relevant Biotech/Biologics industry experience
  • Masters in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 20+ years of relevant Biotech/Biologics industry experience