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 scientists 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 Drug Product team within the Pharmaceutical Development and Manufacturing (PDM) function, the position will be responsible for end-to-end drug product development with focused on late-stage development, formulation and process optimization, scale-up and validation in support of RVMD pipeline compound development and eventual commercialization.     

Responsibilities:

  • Lead or support drug product development activities to advance new chemical entities (NCEs) from early development stage through commercialization.

  • Design and oversee formulation and process development, clinical manufacturing, scale-up, technology transfer, process optimization, and process validation activities related to solid oral dosage drug products at CDMOs.

  • Manage GMP manufacturing of drug products to support clinical studies, primary stability, and process validation.

  • Author and/or review technical reports and CMC-related documents required for regulatory submissions.

  • Design and manage process development studies using a quality-by-design approach. Study and identify critical quality attributes (CQAs) and critical process parameters (CPPs) for drug products. Explore and establish proven acceptable ranges and control strategies for drug product manufacturing.

  • Collaborate with cross-functional teams, including but not limited to Clinical Supply, Quality Assurance, Analytical Development and QC, Drug Substance, Project Management, Regulatory Affairs, and Research teams, to achieve project goals in a timely manner and assist in driving decision-making.

  • Travel to CRO/CDMO sites for the oversight of development and manufacturing activities (up to 20%).

Required Experience, Skills and Education:

  • A graduate degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.

  • 15 + years of experience in the pharmaceutical/biotech industry with end-to-end drug product development and manufacturing experience of small molecules.

  • Thorough understanding and hands-on experience with pharmaceutical drug products including GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.

  • Relevant experience in late-phase drug product development and commercial development with CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China.

  • Excellent communication (both verbal and technical) and problem-solving skills.

  • Working experience in managing and overseeing development and manufacturing activities at CDMOs.

  • Ability to multi-task and thrive in a fast-paced innovative environment.

Preferred Skills:

  • PhD in degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.

The base salary range for this full-time position is $195,000 to $245,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market the candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

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