The Director will lead and facilitate launch readiness and commercial supply of glycoconjugate drug substances, including polysaccharide activation and conjugation processes. This role involves coordinating cross-functional efforts for regulatory filings, facility readiness, and ensuring process robustness throughout the product lifecycle.
Lead the development of digital infrastructure, AI capabilities, and the commercial technology roadmap for the launch of VAX-31. Act as a strategic enabler across Marketing, Sales, Medical Affairs, and Market Access to reduce friction and increase operational leverage.
Lead enterprise-wide efforts to structure, govern, and utilize data and knowledge assets to support process development, clinical, and regulatory activities. Establish systems to capture institutional knowledge and ensure data integrity for commercial regulatory submissions.
Develop and execute global regulatory CMC strategies for investigational products and lead the preparation of regulatory submissions. Manage interactions with Health Authorities and provide regulatory guidance to cross-functional teams to ensure global compliance.
The Associate Director will lead commercial process validation and risk management strategies across end-to-end manufacturing processes. This role involves cross-functional coordination to ensure regulatory compliance, successful technology transfer, and product lifecycle management.
