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%