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) 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.
- 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 multiple 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 Experience, Skills, and Education:
-
Master’s degree with 10+ years or PhD with 8+ years of relevant industrial experience in analytical development.
-
Extensive experience leading analytical activities independently in small molecule drug development.
-
Experience managing projects at CROs/CDMOs.
-
Work experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).
-
Effective written and verbal communication skills and interpersonal skills.
-
Extensive knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices.
-
Strong problem-solving skills with sound technically driven decision-making ability.
-
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.
Preferred Skills:
- PhD (minimum MS degree) in analytical chemistry, organic chemistry or related discipline.
The expected salary range for this role is $160,000 to $200,000. 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 our CCPA Notice and Privacy Policy. For additional information, please contact [email protected].
#LI-Hybrid #LI-CT1