Senior Scientist I, Analytical Development at Revolution Medicines

Ideal for a Scientist with a PhD and at least 5 years of industry experience or an MS with at least 8 years of relevant industrial experience in analytical deve

Work type: hybrid

Location: Redwood City, California, United States

Salary: $149,000 – $186,000/yr

Type: Full-time

Summary

Ideal for a Scientist with a PhD and at least 5 years of industry experience or an MS with at least 8 years of relevant industrial experience in analytical development, this role is critical for supporting late-stage clinical oncology drug development. **What makes it worth a look...** Revolution Medicines offers a full-time hybrid role in Redwood City, California, with a base salary range of $149,000 to $186,000 per year, focusing on developing novel targeted therapies. **You might be a good fit if you...** * Have technical knowledge of analytical technologies like HPLC/UPLC, LCMS, DSC, DVS, and Dissolution. * Possess experience managing projects at CROs/CDMOs and with analytical method development and validation. * Are familiar with regulatory submissions (IND, IMPD, NDA) and ICH/GMP guidelines.

Job Description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals 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.

• Present work and results in team and group meetings.

• 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.

• PhD 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). #LI-Hybrid #LI-CT1

Please note that base pay salary range 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.

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