Director, Process Research and Development - CMC

Company: Revolution Medicines
Location: Redwood City
Posted on: May 22, 2023

Job Description:

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value 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.
Playing a critical role as the technical / project lead of Process R&D within CMC function, the position will be responsible for API process research and development and scale-up manufacturing in support of Revolution Medicines' pipeline compound development and clinical programs. - - -
The Opportunity:

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  Responsible for developing chemical processes for the manufacture of drug substances.
  
  
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  Lead and/or enable technology transfer, process familiarization, and manufacturing at CDMOs.
  
  
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  Conduct process development and optimization studies according to the principles of quality by design (QbD), perform specification justification studies to enable regulatory starting materials designation, establish control limits, perform process characterization studies such as design of experiment (DOE) studies and one variable at a time (OVAT) to identify proven acceptable ranges (PARs) to establish critical process parameters (CPPs), and characterization of API to identify critical process parameters (CQAs).
  
  
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  Propose and/or develop alternative chemistry for drug substance and intermediates, including route evaluation and process optimization.
  
  
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  Assist sourcing and development of raw materials, intermediates, and regulatory starting materials.
  
  
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  Participate in identification, selection, and management of CROs and CDMOs.
  
  
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  Write, review, and approve study protocols, manufacturing batch records, and development and campaign reports.
  
  
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  Author, review the relevant CMC sections of regulatory filings and patent applications.
  
  
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  Work with project team(s) to identify API requirements, manage and optimize aggressive project timelines.
  
  
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  Partner with analytical development, pharmaceutical development, and supply chain functions to design overall CMC strategy for programs.
  
  
  
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    Communicate effectively within cross functional project teams at Revolution Medicines including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Project Management, Legal and Regulatory.
    
    
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    Travel to CRO/CDMO for the oversight of development activities and manufacturing (up to approximately 15%).
    
    
    Required Experience, Skills and Education:
    
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      Preferably a PhD (minimum MSc degree) in organic chemistry, chemical engineering or related discipline.
      
      
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      Proficiency in synthetic organic chemistry.
      
      
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      8 or more years of relevant industrial experience in chemical / drug substance process research and development.
      
      
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      Extensive late stage (Phase III and beyond) small molecule process development, tech transfer and process validation experience.
      
      
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      Knowledge of current ICH guidelines, GMP guidelines, and related industry practices.
      
      
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      Working experience and knowledge of regulatory submission (IND, IMPD, NDA and MAA).
      
      
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      Previous experience managing projects at CROs/CMOs.
      
      
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      Strong problem solving skills with sound technically driven decision-making ability.
      
      
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      Effective written and verbal communication skills and interpersonal skills.
      
      
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      An innovative team-player with high energy for our dynamic company environment.
      
      
      Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company's offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.
      The expected salary range for this role is $195,000 to $245,000. An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. 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.

Keywords: Revolution Medicines, Redwood City , Director, Process Research and Development - CMC, Executive , Redwood City, California