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 within CMC function, as Senior Scientist I, Analytical Development the position will support the manufacturing and control of drug substances and drug products during clinical development. The position will provide analytical support to API process research and development, formulation development, and assist in regulatory filings in support of Revolution Medicines pipeline compound development and clinical programs.

Specifically, you will be responsible for:

• Provide support and oversight to analytical development activities, such as method development, method validation and testing, at contract partner sites to ensure outsourced activities are executed successfully and meet the objectives.
• Provide analytical support for API process R&D and manufacturing, formulation development and drug product manufacturing, and participate in cross-functional project team meetings.
• Critically review data packages associated with method validations, release testing, and other characterization testing for drug substances and drug products.
• Collaborate with cross functional teams in the establishment of control strategy and setting specifications for drug substances and drug products.
• Prepare, review, and/or approve study protocols, study reports, and CMC regulatory submission document.
• Communicate technical findings to colleagues and collaborators within formal and informal settings, including cross-functional project team meetings.
• 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:

• Ph.D. with a min of 8 years industry experience or MS degree with a min of 11 years of relevant industrial experience in analytical development.
• Technical knowledge of analytical technologies including HPLC/UPLC, XRPD, LCMS, DSC, DVS and Dissolution.
• Experience managing projects at CROs/CDMOs.
• Work experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).
• 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 Experience, Skills and Education:

• PhD in analytical chemistry, organic chemistry, or related discipline.
• Small Molecules CMC experience is strongly desired.

The expected salary range for this role is $135,000 to $175,000. 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 privacy@revmed.com.