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Temp Sr. Specialist/ Manager, Quality Control and Stability Management, Analytical Development – CMC

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • 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 subject matter expert (SME) on stability management and quality control operations within Analytical Development - CMC, the position will be mainly responsible for managing stability programs and reference materials, maintaining cGMP-compliant quality control operations and documentation in support of Revolution Medicines pipeline compound development and clinical programs.      

The Opportunity:

  • Coordinate stability activities, including but not limited to monitor schedule, data entry, trending, review and presentations/reports.

  • Track stability studies, maintain stability database.

  • Oversee outsourced stability studies at CDMOs and or contract testing labs.

  • Manage quality events related to stability studies such as lab investigation, deviations, change controls, CAPAs.

  • Author and / or review stability related documents, including protocol, report, and memos.

  • Manage reference materials including monitoring retest date, facilitating qualification/requalification, tracking inventory.

  • Provide support to quality systems and documentation as needed.

  • Collaborate with cross functional teams including Process R&D, Pharmaceutical Development, Toxicology, and Quality Assurance to timely achieve project goals.

Required Experience, Skills and Education:

  • BS or MS in Life Sciences, Chemistry or related discipline.

  • 6+ years of relevant industrial experience in analytical development/QC with 2+ years experience managing stability studies.

  • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to stability study in small molecule drug development.

  • Work experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).

  • Effective written and verbal communication skills and interpersonal skills.

  • Extensive knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices.

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

  • Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.

  • Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

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