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.
* 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
* 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
* 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
* Strong problem solving skills with sound technically driven
* Effective written and verbal communication skills and
* An innovative team-player with high energy for our dynamic