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Senior Scientist II/Principal Scientist, Process Research and Development - CMC

Company: Revolution Medicines, Inc.
Location: Redwood City
Posted on: June 2, 2021

Job Description:

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value 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.

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.

The Opportunity:

* Responsible for developing 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 CMC project team(s) to identify API requirements, manage and optimize aggressive project timelines.

* Responsible for identification, selection, and management 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 Revolution 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 15%).

Required Experience, Skills and Education:

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

* Proficiency in synthetic organic chemistry.

* 8 or more years of relevant industrial experience in pharmaceutical process research and development.

* Both early and late stage small molecule process development and manufacturing experience is desired.

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

* Experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).

* Previous experience managing projects at CROs/CMOs 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.

Keywords: Revolution Medicines, Inc., Redwood City , Senior Scientist II/Principal Scientist, Process Research and Development - CMC, Other , Redwood City, California

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