Director, Drug Product Development

Revolution Medicines, Inc.; San Francisco (CA); On-site; USD 211,000 - 264,000; Full time

Job summary

Revolution Medicines, Inc. in Redwood City, CA, is seeking a Director, Drug Product to lead formulation and process development for small‑molecule and biologic products, guiding programs from candidate assessment through commercialization.

The role includes phase‑appropriate strategy, regulatory alignment, and oversight of external partners. You will oversee clinical drug product manufacturing, technology transfer, lifecycle management, and quality systems, partnering with multiple functions to

Qualifications

• BS/MS/PhD in Pharmaceutical Sciences, Chemical or Biochemical Engineering, Chemistry, Biochemistry, Biophysics, or related field.
• 8+ years of drug product development and manufacturing across small molecules and biologics, with deep technical expertise in at least one modality and ability to lead programs in the other.
• Experience across early and late development including IND-enabling work, clinical development, process validation, and commercial readiness.
• Strong knowledge of small‑molecule dosage form development, biologic formulation, aseptic fill‑finish, packaging, scale‑up, and technology transfer.
• Experience managing CROs, CDMOs, and external manufacturers across GMP activities.

Responsibilities

• Define and execute phase-appropriate drug product strategies for small‑molecule and biologic programs across early- and late-stage development.
• Provide drug product input into candidate selection, developability assessment, pre‑formulation, and dosage form selection.
• Lead formulation and process development for small‑molecule and biologic drug products, including oral, injectable, and lyophilized forms, and aseptic fill‑finish processes.
• Oversee clinical drug product manufacturing and supply from early studies through pivotal trials and registration campaigns.
• Lead late‑stage scale‑up, process optimization, technology transfer, process validation, PPQ execution, and lifecycle management.
• Establish QTPs, CPAs, CQA/CMAs, specifications, and control strategies using QbD and risk management.
• Select and manage CROs, CDMOs, and external partners to meet quality, timeline, and budget goals.
• Author and review drug product sections of INDs, CTAs, IMPDs, NDAs, BLAs, MAAs, and responses to health authorities.
• Partner cross‑functionally with Drug Substance, Analytical Development and Quality Control, Clinical Supply, Regulatory Affairs, Supply Chain, and PM.
• Manage and coach drug product scientists and engineers.

Skills

Drug product development

CRO/CDMO management

Cross-functional leadership

Quality by Design (QbD)

Regulatory submissions

Project management

Education

BS/MS/PhD in Pharmaceutical Sciences or related field

Job description

Revolution Medicines, Inc. in Redwood City, CA, is seeking a Director, Drug Product to lead formulation and process development for small‑molecule and biologic products, guiding programs from candidate assessment through commercialization.

The role includes phase‑appropriate strategy, regulatory alignment, and oversight of external partners. You will oversee clinical drug product manufacturing, technology transfer, lifecycle management, and quality systems, partnering with multiple functions to