Scientist II, Drug Substance - REVOLUTION Medicines

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 scientists 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 manufacturing in support of Revolution Medicines’ pipeline compound development, clinical programs and commercial readiness.   

• Responsible for hands-on development of 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.

• 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 reviews the relevant CMC sections of regulatory filings and patent applications.

• Partner with analytical development, pharmaceutical development, and supply chain functions to design an 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 Experience, Skills, and Education:

• Preferably a Ph.D. (minimum Master’s degree) in organic chemistry, chemical engineering, or related discipline.

• Proficiency in synthetic organic chemistry.

• 2 or more years of relevant industrial experience in chemical/drug substance process research and development.

• Late-stage (Phase III and beyond) small molecule process development, tech transfer, and process validation experience are preferred.

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

• Experience and knowledge of regulatory submissions (IND, IMPD, NDA, and MAA) are desired.

• Previous experience managing projects at CROs/CDMOs is preferred.

• 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.

Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.

The expected salary range for this role is $120,000 to $158,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary 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.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.