Associate Director, Antibody Development

Role Summary

The Associate Director, Antibody Development will lead CMC strategy and execution for antibody and antibody-conjugate programs from sequence handoff through IND and early clinical supply. This role requires hands-on experience in cell line development, a solid understanding of upstream and downstream process development, and the ability to work closely with analytical, quality, regulatory, and external partners. This is a hybrid role based primarily in Cambridge, MA.

Responsibilities

• Lead CDMOs through CHO or other mammalian cell line development activities, including stable pool generation, clone selection, and MCB establishment.
• Provide clear guidance on clone selection strategy, expression systems, and overall development path.
• Work directly with external vendors supporting antibody and antibody-conjugate programs.
• Define clone selection criteria (productivity, product quality, stability) and partner with Discovery/Research to assess developability, manufacturability, expression, and comparability risks.
• Review development reports and batch documentation for upstream activities.
• Oversee cell line development & upstream process development to support tox and GMP campaigns at CRDMOs.
• Build scalability and comparability considerations into early development plans.
• Collaborate closely with analytical and process SMEs to guide method development for potency, purity, aggregates, glycosylation, and product variants.
• Align CMC timelines with overall program milestones and proactively identify technical risks and mitigation plans.
• Ensure documentation readiness for tech transfer and GMP manufacturing.
• Coordinate with Quality and Regulatory to support GMP and IND/CTA readiness.

Qualifications

• PhD in Molecular Biology, Biochemistry, Chemical Engineering, or related field (MS with significant experience considered).
• Minimum 8 years of relevant experience in antibody cell line and process development.
• Direct experience advancing biologics (preferably mAbs or related modalities) into IND/CTA.
• Deep experience with complex or challenging biologics modalities is strongly preferred.
• Strong working knowledge of CDMOs and CROs in the biologics space is required.
• Strong understanding of:
  • CHO cell line development workflows
  • Upstream and downstream process development
  • Analytical characterization of biologics
  • GMP manufacturing and regulatory expectations
• Demonstrated experience managing CDMOs.
• Working knowledge of ICH Q5, Q6, and Q8 principles.