Senior Scientist I, Process R&D - CMC

Recruiter
Revolution Medicines
Location
Redwood City, California
Posted
Nov 01, 2019
Closes
Nov 14, 2019
Ref
09e623bc0dd4
Sector
Science
Organization Type
Corporate
Opportunity

Playing a critical role within CMC as the technical / project lead of Process R&D, the ideal candidate will be responsible for API process development, optimization, scale-up and manufacturing in support of pipeline compound development and clinical programs. Other responsibilities for the role include:
  • Conduct API synthetic route evaluation, process development and manufacturing, technology transfer, and manufacturing processes.
  • Source and develop raw materials, intermediates and regulatory starting materials.
  • Work with project team(s) to identify API requirements, manage and optimize aggressive project timelines.
  • Identify, select and manage CROs and CDMOs.
  • Write, review and approve study protocols, manufacturing batch records, development and campaign reports.
  • Write scientific reports to a broad scientific audience.
  • Author and / or review the relevant CMC sections of regulatory filing documents.
  • Partner with analytical development, pharmaceutical development and supply chain functions to design overall CMC strategy for programs.
  • Interface with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Project Management and Regulatory.
  • Travel to CRO/CDMO for the oversight of development activities and manufacturing (up to approximately 20%).

Required Skills
  • Preferably a PhD (minimum MSc. degree) in organic chemistry, chemical engineering or related discipline with ideally 5+ years of relevant experience in pharmaceutical process research and development.
  • Hands-on experience in non-GMP and GMP API process development, scale-up and manufacturing.
  • Knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices.
  • Working experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).
  • Proven ability to multi-task and handle multiple projects simultaneously with strong problem-solving skills and technically driven decision-making ability.
  • Excellent organizational skills, detail oriented and thrives in a collaborative team setting.
  • Effective communication skills (verbal, written and technical) and interpersonal skills.
  • Team-oriented, progressive thinker who enjoys participating in an innovative, creative and high-energy work environment.

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