Director, Drug Substance

About the role

Playing a critical role as a technical lead within the Drug Substance function, the position will be responsible for process research and development and scale-up of manufacturing in support of Revolution Medicines' pipeline compound development, clinical programs and commercial readiness.

Responsibilities

• Responsible for developing chemical processes for the manufacture of drug substance, intermediates and/or starting materials, including route evaluation and process optimization.
• Conduct process development and optimization studies according to the principles of quality by design (QbD), to enable regulatory starting materials designation, establish control strategy and process characterization studies using tools such as design of experiment (DOE) studies.
• Lead and/or enable technology transfer, process familiarization, and manufacturing at CDMOs.
• Participate in identification, selection, and management of CROs and CDMOs including management of redundant supply and geographic diversity.
• Write, review, and approve protocols, manufacturing batch records, and development and campaign reports.
• Author, review the relevant CMC sections of regulatory filings and patent applications.
• Partner with analytical development, pharmaceutical development, and supply chain functions to design overall strategy for programs.
• Communicate effectively within cross functional project teams.
• Travel to CRO/CDMO for the oversight of development activities and manufacturing (up to approximately 15%).
• Required Skills, Experience and Education:
• PhD (minimum MSc degree) in organic chemistry, chemical engineering or related discipline.
• 10 or more years (15+ years for Master's degree) of relevant industrial experience in chemical / drug substance process research and development.
• Strong people management skills.
• Hands-on proficiency in synthetic organic chemistry.
• Knowledge of current ICH guidelines, GMP, and relevant industry practices.
• Working experience and knowledge of regulatory submissions (IND, IMPD, NDA and MAA).
• Previous experience managing projects at CROs/CDMOs.
• Strong problem solving skills with sound technically driven decision-making ability.
• Effective written and verbal communication skills and interpersonal skills.
• An innovative team-player with high energy for our dynamic company environment.
• Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
• Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
• Base Pay Salary Range
• $211,000 - $264,000 USD
• Please note that Revolution Medicines does not exten

Benefits

Additional Information

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

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