VP, API Manufacturing

Location United States of America
Contact name: Sam Murphy

Contact email: sam.murphy@rbwconsulting.com
Contact phone: 6175951613
Job ref: 8348374385959
Published: 19 days ago
Expiry date: 01 Jun 2024 23:59


  • Independently devise synthetic pathways for target molecules, conduct Process Research and Development, and oversee API process research projects to create efficient, scalable, and reliable drug manufacturing processes.

  • Develop manufacturing routes and strategies for drug substances, including raw materials and intermediates.

  • Strategically plan and provide technical support for contract manufacturing organizations (CDMOs), overseeing manufacturing batches and development documentation.

  • Facilitate technology transfer and process optimization with external parties involved in drug substance manufacturing, ensuring on-site support as needed.

  • Collaborate across functions to ensure compliance with GMP and global regulatory standards.

  • Author and review CMC sections for regulatory filings such as INDs, IMPDs, NDAs, and MAAs.

  • Provide technical support and documentation during regulatory submission reviews.

  • Supervise and lead a team of CMC chemists and related personnel.