Director, Drug Substance

10 or more years (15+ years for Master’s degree) of relevant industrial experience in chemical / drug substance process research and development.

Hands-on proficiency in synthetic organic chemistry.

Knowledge of current ICH guidelines, GMP, and relevant industry practices.

Previous experience managing projects at CROs/CDMOs.

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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.

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.