Development: Scientist / Senior Scientist, Analytical Development – 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 subject matter expert (SME) and project lead of Analytical Development within CMC function, the position will be responsible for analytical method development/validation/transfer and managing release testing, reference standard qualification and stability programs in support of Revolution Medicines pipeline compound development and clinical programs.      

Opportunity
  • Lead day-to-day operations to provide analytical support for API process R&D and manufacturing, formulation development and drug product manufacturing, and participate in cross-functional project team meetings.

  • Contribute to analytical development strategy for variety projects.

  • Demonstrate technical expertise on analytical technologies and act as a subject matter expert for Analytical Development function.

  • Select appropriate analytical techniques and coach and/or manage the contract lab counter parts to perform analytical method development/validation/transfer to support development and manufacturing of API and drug product.

  • Critically review data from contract partners (CDMOs and/or CTLs).

  • Manage stability testing programs assigned.

  • Prepare, review, and/or approve study protocols, study reports, and CMC regulatory submission document.

  • Collaborate with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Pharmaceutical Development, Process R&D, Project Management and Regulatory to timely achieve project goals.

Required Skills
  • Ph.D. or M.S. in analytical chemistry, organic chemistry or related discipline.

  • 3+ years of relevant experience in analytical development preferably supporting early phase drug development.

  • Hands-on experiences in analytical method development using HPLC/UPLC/GC, cKF, and dissolution.

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

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

  • Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.

  • Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

  • Ability to multi-task and thrive in a fast-paced innovative environment.


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