Senior Scientist II (Associate Director) / Principal Scientist (Director), Pharmaceutical Development – 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 Pharmaceutical Development within CMC function, the position will be responsible for preformulation studies, formulation and process development, optimization, scale-up and manufacturing in support of Revolution Medicines pipeline compound development and clinical programs.

Accountable for:

  • Lead optimization, API form selection/characterization, preformulation, formulation development, manufacture of clinical supplies.

  • Development of efficient and scalable manufacturing processes, process scale up based on Quality by Design (QbD).

  • Lead identification, selection and management of Contract Development and Manufacturing Organization (CDMOs) for formulation development and drug product manufacturing.

  • Work with project team(s) to identify drug supply 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, study reports, 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, Process R&D, 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 in pharmaceutical sciences, chemical engineering, physical organic chemistry or related discipline.

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

  • Experience in pre-formulation, formulation and process development, scale-up and manufacturing of oral and /or parenteral drug products.

  • Expertise and experience in poorly water drug delivery technologies and enabling formulation development.

  • Sound understanding of the principles and practices of chemistry or pharmaceutical science and can integrate and apply this knowledge effectively to formulate new chemical entities.

  • Knowledge of basic analytical skills required: HPLC, UV, solid state characterization.

  • 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.

  • Excellent communication skills (both verbal and technical) and interpersonal skills are required.

  • Ability to mentor technical staff.

  • Ability to lead, plan and achieve the Pharmaceutical Development function goals.

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


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