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Director, Drug Product

Revolution Medicines · Redwood City, California, United States · On-site

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About Revolution Medicines

Backed by GV.

About the role

The Director, Drug Product, will lead formulation and process development activities for small-molecule and biologic drug products within the Pharmaceutical Development & Manufacturing (PDM). The role will oversee development of portfolio programs from candidate assessment, preformulation, and IND-enabling studies through clinical development, registration, technology transfer, process validation, commercialization, and lifecycle management.

What they're looking for

  • BS/MS/PhD in Pharmaceutical Sciences, Chemical or Biochemical Engineering, Chemistry, Biochemistry, Biophysics, or related scientific/engineering discipline
  • 8+ years of experience in drug product development and manufacturing across small molecules and biologics, with deep technical expertise in at least one modality and demonstrated ability to lead programs in the other
  • Experience spanning early development and late-stage development, including candidate assessment or IND-enabling work, clinical development, registration, process validation, and commercial readiness
  • Strong knowledge of small-molecule dosage form development and biologic formulation, aseptic fill-finish, primary packaging, scale-up, and technology transfer
  • Experience managing CROs, CDMOs, and external manufacturing partners across development and GMP manufacturing activities
  • Strong knowledge of cGMP, QbD, pharmaceutical risk management, process validation, and applicable FDA, EMA, and ICH requirements
More about this role

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Director, Drug Product, will lead formulation and process development activities for small-molecule and biologic drug products within the Pharmaceutical Development & Manufacturing (PDM).

The role will oversee development of portfolio programs from candidate assessment, preformulation, and IND-enabling studies through clinical development, registration, technology transfer, process...

Read the full posting on Revolution Medicines's site ↗

Drug Product

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