Senior Scientist II / Principal Scientist, Process R&D – CMC

REVOLUTION Medicines discovers and develops new drugs that translate frontier cancer targets through exceptional drug discovery delivering revolutionary medicines on behalf of cancer patients.  Our innovative science draws inspiration from nature and evolution, which offer insights into cancer targets, disease mechanisms and therapeutic approaches.  As a new member of the RevMed team, you will join other outstanding scientists who are helping lead our efforts in the discovery and development of new medicines for unmet needs in cancer.

Opportunity

Playing a critical role as the technical / project / functional lead of Process R&D within CMC function, the position will be responsible for API process development, optimization, scale-up and manufacturing in support of Revolution Medicines pipeline compound development and clinical programs.

  • Be responsible for the API supply chain and deliverables

  • Synthetic route evaluation, developability and processability assessment

  • Design and execution of the process R&D relevant studies

  • Identification, selection and management of CROs and CDMOs

  • Starting materials and intermediates sourcing and development 

  • API process development, transfer, optimization, scale-up and manufacturing  

  • Work with project team(s) to identify API requirements, manage and optimize aggressive project timelines.

  • Communicate strategy and project status to ensure senior stakeholders and assist decision-making.

  • Prepare, review and/or edit, approve study protocols, manufacturing batch records, development and campaign reports.

  • Prepare, review and/or edit CMC regulatory and Quality documents.  

  • Interface with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Analytical Development, Pharmaceutical Development, 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 chemistry, chemical engineering or related discipline.

  • Ideally 10+ years of process chemistry experience with a track record of scientific and project leadership.  

  • 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).

  • Strong problem skills with sound technically driven decision-making ability.

  • Effective written and verbal communication skills.

  • Ability to mentor technical staff.

  • Ability to lead, plan and achieve the Process R&D function goals.

  • Ability to navigate, innovative team-player with high energy for our dynamic company environment.


APPLY FOR THIS POSITION