Development: Scientist II / Senior Scientist I, Process Chemistry – CMC

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit elusive frontier targets in RAS-addicted cancers.  The company’s R&D pipeline includes RMC-4630, a clinical-stage investigational drug that is designed to selectively inhibit the activity of SHP2, an upstream node in RAS signaling. Preclinical programs include inhibitors of multiple mutant RAS proteins and SOS1.  RMC-5552, currently in IND-enabling development, is designed for use against tumors featuring mTORC1 activation, particularly certain RAS-addicted cancers.  As a new member of the Revolution Medicines team, you will join other outstanding scientists who are helping lead our efforts in the discovery and development of new medicines for unmet needs in cancer.

Playing a critical role as the technical/project lead of Process R&D within CMC function, the position will be responsible for API process research and development, process optimization, and scale-up manufacturing in support of Revolution Medicines’ pipeline compound development and clinical programs.   

  • Develop chemical processes for the manufacture of drug substances.

  • Manage technology transfer, process familiarization, and drug substance manufacturing at CDMOs.

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

  • Source and develop raw materials, intermediates, and regulatory starting materials.

  • Work with project team(s) to identify API requirements, manage and optimize aggressive project timelines.

  • Identify, select, and manage of CROs and CDMOs.

  • Write, review, and approve study 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 CMC strategy for programs.

  • Communicate effectively within cross functional project teams at Revlution Medicines including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Project Management, Legal and Regulatory.

  • Travel to CRO/CDMO for the oversight of development activities and manufacturing (up to approximately 20%).

Required Skills
  • Preferably a PhD (minimum MSc degree) in organic chemistry, chemical engineering or related discipline.

  • 3+ years of relevant experience in pharmaceutical process research and development.

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

  • Hands-on experience in non-GMP and GMP API process development, scale-up, and manufacturing .

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

  • Working experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).

  • 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.