Director, CMC at Revolution Medicines
Redwood City, CA, US
REVOLUTION Medicines is an exciting, early stage biotechnology company that discovers and develops innovative drugs for cancer patients directed toward frontier oncology and immune-oncology targets. The company draws inspiration from evolution and natural products that are inherently rich with biological function. REVOLUTION Medicines deploys an innovative toolkit including REVBLOCKS™, an integrated suite of rapid, agile, and modular synthesis methodologies applied to simple chemical “building blocks,” and the REVEAL™ computational platform, which uses evolution’s lessons to inform selection of chemical scaffolds guide drug design for non-classical drug targets. 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.

Key Responsibilities:

Lead the identification, selection and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of RevMed clinical programs:
Drug Substance: Synthetic route evaluation/selection, salt selection, process optimization and scale-up.

Drug Product: pre-formulation characterization, development of phase appropriate dosage formulations, process optimization and scale-up.

Analytical: phase appropriate method development and qualification/validation, develop appropriate specifications for drug substances and drug products - provide guidance for establishing appropriate stability programs to support desired retest and expiry dating of drug substance and drug product.

Ensure delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile. Provide strategic guidance in developing and validating product and process parameters in a time and cost-sensitive manner.

Lead the formulation design/development for RevMed clinical programs.

Actively manage the supply chain and logistics in support of RevMed clinical studies.

Communicate strategy and project status to senior stakeholders and assist in driving decision making. Prepare technical reports, publications and oral presentations.

Identify and monitor critical path activities of vendors and develop contingency plans when the project deviates from that path.

Oversee or act as technical lead in development projects and ensure execution of plans and program objectives.

Interact with cross-discipline personnel to integrate technical information across project activities, specifically communication of CMC-related topics.

Interface with Regulatory Affairs to communicate CMC topics for regulatory submissions.

Develop budgets and resource planning to achieve product development goals.

Writing and reviewing documents for INDs / regulatory section submissions; represent RevMed as the CMC expert before U.S. and European regulatory authorities.

Prepare, review and/or edit cGMP batch records, CMC regulatory and Quality documents.

Required Experience, Skills, and Education:

Preferably a PhD (minimum Bachelor’s degree) in chemistry, chemical engineering or related discipline with a deep understanding of small molecule synthetic chemistry and demonstrable expertise in CMC.

Ideally 10+ years of CMC/process chemistry experience with a strong track record of scientific leadership with managing CMC teams and overall successful CMC campaigns.

Drug product/process development experience advancing programs through the clinic, including analytical chemistry from method development to validation/route testing.

Experience with process scale up and improvement programs.

Thorough understanding and experience of CMC considerations with respect to GMP, quality systems, FDA and associated regulatory requirements, specifically late stage investigational new drug applications (IND).

Familiarity with US and international regulatory guidance and processes including experience with Regulatory Affairs CMC requirements and expectations, including writing related submissions.

Experience with supply chain management.

Excellent written and verbal communication skills to work with interdepartmental teams.

Innovative team-player with high energy for our dynamic company environment.

Ability to mentor technical staff.

Demonstrated ability to lead, plan and achieve CMC function goals as part of interdisciplinary project teams.