Director

• Manage multiple CMOs and CROs to deliver bulk starting materials, intermediates, and drug substance of sufficient quality and quantity to meet corporate and regulatory requirements
• Establish and maintain business relationships with CROs and CMOs for process validation and commercial supply requirements
• Lead late-stage drug substance process finalization, validation, and commercial-scale manufacturing
• Identify and lead key process problem resolution activities and process improvement initiatives
• Work closely with Quality Assurance to develop and operate appropriate CMC procedures and ensure product meets established quality standards
• Create and disseminate technical transfer information required by CROs and CMOs to develop and scale up chemical processes and develop and validate analytical methods
• Support authorship, review, and response to queries on all Module 3 drug substance development sections of CTD and contribute to regulatory control strategy
• Support a culture of continuous improvement and high-performance teamwork

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