VP, API Manufacturing

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SUMMARY OF ESSENTIAL JOB FUNCTIONS:

• 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.