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VP, API Manufacturing
5 months ago
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.
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