Senior Scientist II, Analytical Development

Revolution Medicines•Redwood City, CA

5d•Onsite

About The Position

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide. Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients. The Opportunity: 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.

Requirements

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

Nice To Haves

PhD (minimum MS degree) in analytical chemistry, organic chemistry or related discipline

Responsibilities

Lead day-to-day operations to provide analytical support for API process R&D and manufacturing, formulation development and drug product manufacturing
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