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Principal Scientist, Analytical Development

Location: Redwood City
Posted on: September 21, 2023

Job Description:

Principal Scientist, Analytical Development at Revolution Medicines Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit 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. The Opportunity: Playing a critical role as the subject matter expert (SME), project lead of Analytical Development within the PDM function, the position will be responsible for analytical enablement of Revolution Medicines pipeline compound development and clinical programs, such as control strategy development for DS and DP, method development/validation/transfer and managing release testing. Responsibilities: Lead day-to-day analytical project activities to support the development and manufacturing of API and DP, and participate in cross-functional PDM project team meetings. Select appropriate analytical techniques and manage contract partners (CDMOs and/or CTLs) to perform analytical method development/validation/transfer, oversee release testing as well as resolve any OOSs/OOTs. Demonstrate technical expertise in the development of analytical methods and phase-appropriate control strategies for API and DP. Author and review Quality sections of regulatory submissions, and respond to queries from regulatory agencies. Prepare, review, and approve study protocols and reports. Collaborate with cross-functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Pharmaceutical Development, Process R&D, Project Management, and Regulatory Operations to timely achieve project goals. Education, Experience, and Skills Requirement: Preferably a Ph.D. (minimum MS degree) in analytical chemistry, organic chemistry, or related discipline. 6+ years of relevant industrial experience in analytical development. Extensive late-phase experience leading analytical activities in small molecule drug development. Excellent scientific and business communication skills (verbal, written, and presentation), strong interpersonal/collaboration skills, and planning skills. In-depth understanding of CMC enablement of small molecule drug development. Extensive experience managing projects at CROs/CDMOs. Working experience and knowledge of regulatory submission (IND, IMPD, and/or NDA, MAA). Extensive knowledge and understanding of current ICH, GMP guidelines, and related industry practices. Ability to think critically and creatively and be able to work independently and on a team to determine appropriate resources for the resolution of problems. Strong problem-solving skills with sound technically driven decision-making ability. Ability to multi-task and thrive in a fast-paced innovative environment. Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company's offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law. The expected salary range for this role is $195,000 to $245,000. An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. 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. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with ourCCPA Notice andPrivacy Policy .For additional information, please .

Keywords: THIRD ROCK VENTURES, LLC, Redwood City , Principal Scientist, Analytical Development, Other , Redwood City, California

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