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Senior Scientist I / II, Process R&D – CMC
at Revolution Medicines in California
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.
Responsibilities:
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.
Work with project team(s) to identify API requirements, manage and optimize aggressive project timelines.
Write, review, and approve study protocols, manufacturing batch records, and development and campaign reports.
Author/review the relevant CMC sections of regulatory filings.
Communicate effectively within cross functional project teams at Revlution Medicines.
Required Experience, Skills and Education:
Preferably a PhD (minimum MSc degree) in organic chemistry, chemical engineering or related discipline.
5+ 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.
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.
Reference : Senior Scientist I / II, Process R&D – CMC jobs
Reference : Senior Scientist I / II, Process R&D – CMC jobs
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Viewed: 429 times
Viewed: 429 times