Senior Scientist II, Analytical Development
About The Position
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 Revolutionaries 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.
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, 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
Number of Employees
501-1,000 employees
