Senior Scientist I, Drug Substance

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

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.

• Manage sourcing and manufacture of raw materials, intermediates, and regulatory starting materials and be accountable to project team to meet aggressive timelines .

• 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.

• 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

• Propose and/or develop alternative chemistry for drug substance and intermediates, including route evaluation and process optimization.

• 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 Master’s degree) with 5 or more years of relevant industrial experience in chemical / drug substance process research and development.

• in organic chemistry, chemical engineering or related discipline.

• 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.

Preferred Skills:

• PhD (minimum Master’s degree) in organic chemistry, chemical engineering or related discipline. #LI-Hybrid #LI-CT1