Director, CMC – Biologics & ADC

Pathos•New York, NY

3d•$210,000 - $250,000•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.
Experience with high-concentration development is a plus
Lyophilization experience is a plus

Responsibilities

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.
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.
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.