Senior Manager, Analytical Development & Qc

Revolution Medicines

Redwood City, United States
Base: $164,000—$205,000 usd; bonus/equity: not spe...
On-site
Manage outsourced qc activities at cdmos
Manage quality events related to qc testing
Author and/or review qc related documents
Revolution Medicines is seeking a Senior Manager of Analytical Development & QC to lead quality control activities for their clinical and commercial programs in oncology. The ideal candidate will have extensive experience in analytical development and a solid understanding of regulatory requirements, with responsibilities including managing QC activities, stability programs, and cross-functional collaboration

Job Summary

  • Playing a leading role and Subject Matter Expert (SME) of Quality Control within PDM Analytical Development & QC department in support of RevMed clinical and commercial programs.
  • The position will be mainly responsible for managing QC activities from process validation to commercial manufacture of drug substance (DS), drug product (DP) and final product (FP).
  • The candidate will also participate in post-approval QC related activities including lifecycle management regulatory submissions such as CBE, PAS, etc.

Matching Summary

Match Score: 85

Revolution Medicines is seeking a Senior Manager of Analytical Development & QC to lead quality control activities for their clinical and commercial programs in oncology. The ideal candidate will have extensive experience in analytical development and a solid understanding of regulatory requirements, with responsibilities including managing QC activities, stability programs, and cross-functional collaboration.

Salary

Base: $164,000—$205,000 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Manage outsourced QC activities at CDMOs
  • Manage quality events related to QC testing
  • Author and/or review QC related documents
  • Lead method validation/transfer activities
  • Manage reference standards and materials
  • Collaborate with cross-functional teams

Nice-to-have

  • Experience in solid oral dosage
  • Commercial QC experience
  • Knowledge of global regulatory submissions
  • Chromatographic experience

Key Requirements

  • 6+ years of relevant industrial experience
  • BS or MS in Chemistry, Pharmaceutical Science or related discipline
  • Solid understanding of compliance and regulatory requirements
  • Extensive knowledge of cGMP guidelines and practices

Work Rights

Not specified

Tailored Resume

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