CMC Biologics & ADC Director – Oncology

Pathos AI; New York (NY); Hybrid; USD 210,000 - 250,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Pathos AI seeks a Director of CMC – Biologics & ADC to drive the chemistry, manufacturing, and controls strategy for antibody and ADC oncology programs. This role owns upstream and downstream development, analytical development, and manufacturing, ensuring phase-appropriate quality and regulatory-ready documentation.

You will build the CMC function from early stage, collaborating with Research, Regulatory, and Quality in a fast-moving environment.

Qualifications

• PhD in Biochemistry, Chemical/Biochemical Engineering, Biotechnology, or related field (or MS/BS with commensurate experience).
• 8–10+ years of biopharmaceutical CMC experience with antibody upstream/downstream and analytics.
• Hands-on ADC manufacturing: conjugation, DAR control, high-potency containment.
• Experience in oncology drug development and regulatory submissions.
• Proven success managing CDMOs, tech transfer, scale-up, and GMP manufacturing.

Responsibilities

• Define end-to-end biologics/ADC CMC strategy for oncology programs.
• Lead CMC program as single point of accountability with cross-functional teams.
• Translate goals into phase-appropriate development plans, budgets, and risk plans.
• Oversee upstream/downstream process development from bench to scale-up.
• Coordinate ADC conjugation/manufacturing and supply chain across CDMOs.
• Own analytical development, characterization, and comparability strategies.
• Author/review CMC regulatory submissions and support health-authority interactions.

Skills

CMC strategy

Biologics

ADC development

Regulatory submissions

CDMO management

GMP knowledge

Oncology

Cross-functional leadership

Education

PhD in Biochemistry/related field

MS/BS with commensurate experience

Job description

Pathos AI seeks a Director of CMC – Biologics & ADC to drive the chemistry, manufacturing, and controls strategy for antibody and ADC oncology programs. This role owns upstream and downstream development, analytical development, and manufacturing, ensuring phase-appropriate quality and regulatory-ready documentation.

You will build the CMC function from early stage, collaborating with Research, Regulatory, and Quality in a fast-moving environment.