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Manager, Drug Product

Posted 18 days ago

  • Sector: Pharmaceutical, Biotech
  • Contact: Stefanni LaJeunesse
  • Contact Email: s.lajeunesse@sciproglobal.com
  • Expiry Date: 29 April 2021

SciPro has teamed up with a premier client in the Biotechnology Industry with a strong focus in biosimilars and Immuno-oncology looking for their next Manager, Drug Product.

In this role, you would will provide technical support for drug product technology transfers and manufacturing, including CMO oversight to ensure successful clinical and commercial production.

  • Provide subject matter expertise for drug product manufacturing unit operations

  • Identify, design, execute, evaluate, and document studies characterizing drug product processes based on solid scientific and engineering principles

  • Ensure syringe and vial aseptic fill technology transfer activities are executed at CMO site per process procedures and best practices

  • Provide technical support to manage deviations, corrective actions, change controls, process monitoring, and process improvements

  • Provide Person-In-Plant oversight of development and manufacturing activities at CMO sites

  • Ensure compliance with international (ICH, EMA), and U.S. (CFR, FDA, USP, OSHA) regulations and license requirements including current Good Manufacturing Practices (cGMP)


Experience Requirements for Manager, Drug Product:

  • Minimum BS required, degree in chemical engineering or similar field

  • Minimum of 5 years drug product experience in the biopharmaceutical industry

  • Must have strong knowledge of biologics manufacturing and aseptic processing expertise

  • Must have experience with drug product process development

  • Prior experience managing third-party CMO relationships and as Person-In-Plant during manufacturing runs

  • Experience with statistical software such as JMP or Minitab desirable

  • Ability to travel domestically and internationally, up to 25%