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Sr. Director, Pharmaceutical Development and CMC Lead

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Industry: Biotechnology
  • Post Date: 09/20/2022
  • Website: www.revmed.com
  • Company Address: 700 Saginaw Drive, Redwood City, CA, 94063

About Revolution Medicines

REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients. Our innovative product engine draws inspiration from nature and evolution, which offer insights into cancer targets, disease mechanisms and therapeutic approaches.

Job Description

Playing a critical role as the drug product technical lead and CMC project lead, the position will be responsible for drug product development activities leading to NDA submission and commercialization, as well as the development and execution of the CMC strategy.  The individual will provide technical and project leadership, and work with cross-functional stakeholders to ensure pharmaceutical drug product development and CMC activities are executed seamlessly and in alignment with the integrated product development plan and program timelines.

The Opportunity:

  • Lead drug product development activities from early to late development through commercialization.

  • Lead drug product technical transfer, process development, optimization, qualification, and validation of activities related to all manufacturing operations. 

  • Design and oversee the execution of QbD and risk-based studies, as well as process development activities in preparation for registration, validation, and commercialization activities.

  • Be responsible for the development of strategies, overseeing the execution of technical activities associated with product development and manufacturing in support of clinical development, regulatory filings (IND/NDA/MAA), and product approvals and commercialization.

  • Author/review the relevant CMC sections to enable global regulatory filings.

  • Lead cross-functional CMC team for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies.

  • Serve as a project core team member and communicate CMC strategy and project status to key stakeholders cross-functionally and assist in driving decision-making.

  • Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to ensure CMC and program goals are met.

  • Travel to CDMOs for vendor assessment and qualification, as well as manufacturing oversight as needed.

Required Experience, Skills, and Education: 

  • Preferably a Ph.D. (minimum MSc degree) in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field is desirable.

  • 18 + years of experience in the pharmaceutical/biotech industry with a sound track record of technical expertise and leadership, early and late phase drug product development experience of small molecules.

  • Demonstrated strong project and cross-functional team leadership, as well as people management

  • Thorough understanding and working experience of the pharmaceutical drug product with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.

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

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

  • Excellent written and verbal communication skills and interpersonal skills.

  • 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.

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.

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