Director, CMC – Biologics & ADC

Drug development shouldn’t be guesswork, not when patients are waiting.

• Define and execute the end-to-end biologics/ADC CMC strategy for one or more oncology programs, spanning antibody drug substance, conjugation, and drug product.
• Serve as the CMC program lead and single point of accountability, representing CMC on cross-functional program teams alongside Research, Clinical, Regulatory, and Quality.
• Translate program goals and timelines into phase-appropriate development plans, budgets, and risk-mitigation strategies.

• Expert in biologics cell line and drug substance development.
• Lead upstream process development for antibodies — cell line development oversight, media/feed optimization, and fed-batch/perfusion bioreactor processes from bench through scale-up.
• Lead downstream process development — harvest/clarification, Protein A and polishing chromatography, viral clearance, ultrafiltration/diafiltration, and formulation.
• Apply QbD and risk-based approaches to establish robust, scalable, and controllable processes and control strategies.

• Direct ADC-specific CMC activities including linker-payload strategy, conjugation process development, and drug-to-antibody ratio (DAR) control.
• Oversee ADC drug substance and drug product manufacturing, including handling of high-potency payloads and appropriate containment (OEB) controls.
• Coordinate the multi-component supply chain (antibody intermediate, linker-payload, conjugated drug substance, and drug product) across specialized CDMOs.
• Experience with high-concentration development is a plus 
• Lyophilization experience is a plus

• Own the analytical strategy for antibodies and ADCs — method development, qualification/validation, specifications, and stability.
• Direct product characterization and comparability, including purity/impurities, aggregation, charge variants, glycosylation, potency/bioassays, DAR, free-drug, and other ADC-critical quality attributes.
• Design and execute studies to assess protein stability, aggregation, degradation pathways, viscosity, and developability under relevant formulation conditions.

• Select, manage, and technically oversee CDMOs for antibody and ADC manufacture, leading tech transfer, scale-up, engineering, and GMP campaigns.
• Ensure timely, phase-appropriate clinical supply (Phase 1–3) and lead process performance/validation to support late-stage development and commercialization.
• Author and review CMC sections of regulatory filings (IND, IMPD, briefing documents, and later BLA/MAA modules) and support health-authority interactions.
• Partner with Quality to ensure GMP compliance, manage deviations and change control, and support audits. 

• Ph.D. in Biochemistry, Chemical/Biochemical Engineering, Biotechnology, or a related field (or an M.S./B.S. with commensurate additional experience).
• 8–10+ years of biopharmaceutical CMC experience with demonstrated depth in antibody upstream AND downstream process development and analytics.
• Hands-on experience with ADC manufacturing — conjugation chemistry, linker-payload handling, DAR control, and high-potency containment.
• Direct experience in oncology drug development.
• Proven track record across the full development lifecycle: phase-appropriate development for Phase 1–3 as well as hands-on experience with late-stage development.
• Experience in BOTH a small/emerging biotech and a large pharma environment, with the versatility to operate effectively in each.
• Demonstrated success managing CDMOs and leading technical transfer, scale-up, and GMP manufacturing for biologics and/or ADCs.
• Strong command of ICH, FDA, and EMA guidance for biologics/ADCs and phase-appropriate GMP expectations, with experience authoring CMC regulatory submissions.

• Experience taking a biologic or ADC oncology asset through pivotal/late-stage development and toward registration (BLA/MAA).
• Familiarity with site-specific/next-generation conjugation, novel payload classes, or bispecific antibody formats.
• Experience with comparability strategies and control of ADC-specific critical quality attributes across process changes.
• Comfort operating in a data- and technology-forward organization; interest in leveraging AI/ML to accelerate CMC decision-making.

• Reliable, phase-appropriate clinical supply of antibody and ADC material that never gates the clinical program.
• Robust, scalable processes and well-controlled critical quality attributes that de-risk late-stage development.
• Clean, defensible CMC regulatory submissions and successful health-authority interactions.

This is a hybrid role, requiring 3 days per week onsite, in our NYC Headquarters.