Developing and implementing CMC strategies with cross functional teams to manage mRNA vaccine platforms for internal and external CMO sites to meet critical business milestones Manage supply chain of GMP raw materials including custom lipids to avoid disruption in clinical forecast.Lead site readinesss activities focused on quality inspections by regulatory authorities and business partners.Manage CMC P3 readiness for key program which includes process, analytical, raw material, vendor management, automation implementation, etc. Plan and manage budget to ensure capital is secured to achieve business objectives

Supported CMC activities for manufacturing and release of drug substance and drug product, manufacturing process improvements, raw material and material supplier selection and qualification, process validation, process and analytical tech transfer, and product launch related activities.

Provide leadership and guidance in executing CMC related activities for product in various stages of clinical development and/or commercial launch by working closely with cross functional teams. Create and manage development plans and budgets.Oversee contract manufacturing sites, testing, packaging and labeling operations for drug substance and drug product. Provide support for process and analytical tech transfer, process optimization, product qualification and validation activities. Ensure timely communication between all stakeholders including senior management.

Global management of CMC related activities for drug substance and drug product such as steady CTM supply, global regulatory submissions, addresssing regulatory deficiencies (FDA, CTA, EMEA, ANVISA, ANVIMA, PMDA, etc), successful commercial launches, stable commercial supply, life cycle managment. Work with various cross functional teams such as regulatory, quality, supply chain, technical, marketing and sales, clinical.

Supported activities for clinical trials such as IND submissions, briefing documents for FDA meetings, CTM supply for all clinical stages (Phase 1-1V), management of CMO activities. Involved in due diligence related activities. Worked on module 3 CTD documents for global NDA submissions in major territories (US, EU and JP). Managed technical transfer of commercial product with successful PAS resulting in significant cost saving. Managed authorized generic collaboration with cross-funcational team resulting in successful transfer and timely launch.