Job Details

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 mutationsin 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.
• Present work and results in team and group meetings.Required Skills, Experience, and Education:
  • Ph.D. with a min of 5 years industry experience or MS degree with a min of 8 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.
  • Experience with analytical method development, validation and method transfer.
  • 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 Skills:
    • Ph.D or MS in analytical chemistry, organic chemistry, or related discipline.
    • CMC experience with small Molecules is strongly desired, and experience in solid oral dosage is a plus.
    • Familiarity with document management systems (such as Veeva or similar).The base salary range for this full-time position is $140,000 to $180,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.Please note that 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 ourand.For additional information, please contact.#LI-Hybrid #LI-CT1
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