Drug development shouldn’t be guesswork, not when patients are waiting. Pathos is building a next-generation biotech with AI at the core. Not as a feature, but as the operating system for how medicines get developed. Backed by NEA.
About the role
We are seeking a Director, CMC – Biologics & ADC to lead the chemistry, manufacturing, and controls strategy for our antibody and antibody-drug conjugate (ADC) oncology programs. This individual will own upstream and downstream process development, analytical development, and ADC conjugation/manufacturing — from early clinical supply through late-stage development — ensuring phase-appropriate quality, robust and scalable processes, and regulatory-ready documentation.
What they're looking for
- 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
More about this role
We are seeking a Director, CMC – Biologics & ADC to lead the chemistry, manufacturing, and controls strategy for our antibody and antibody-drug conjugate (ADC) oncology programs. This individual will own upstream and downstream process development, analytical development, and ADC conjugation/manufacturing — from early clinical supply through late-stage development — ensuring phase-appropriate quality, robust and scalable processes, and regulatory-ready documentation. This is a foundational hire on the Pathos CMC/Technical Operations team. You will help build and scale the chemistry, manufacturing, and controls function from an early stage, working shoulder-to-shoulder along with the Head of CMC with Research, Clinical, Regulatory, and Quality colleagues in a fast-moving, resource-conscious environment. You are equally comfortable rolling up your sleeves on technical detail and operating strategically across a portfolio.
What You Will Do
CMC Strategy & Program Leadership
- 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...
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