API Project Execution Lead
Work as part of a cross-functional matrix team to ensure successful manufacture of active pharmaceutical ingredients, chemical intermediates and specialty materials to support development of R&D pipeline products.
Key responsibilities include:
- Development of the API delivery strategy integrating material delivery needs across the organization with process development requirements. Partners with Strategic Partner Management in development of the sourcing strategy and plan.
- Execution of API delivery plan, including ownership of the overall delivery timeline and associated project management to ensure that all campaign goals are met (e.g., safety, quality, and knowledge).
- Leads execution of external manufacturing efforts. Uses a cooperative approach with Strategic Partner Management, Quality, and Development teams to manage interactions with suppliers and deliver against the scope of work.
- Point of contact for the Supplier Virtual Plant Team where appropriate to facilitate progress against statements of work.
- Develop and maintain project schedule that maintains alignment with all on-going internal and external activities such as analytical transfer activities, document review periods, material delivery timing, batch execution timelines, project close-out deliverable and batch release time lines, etc.
- Serve as interface to Quality and Safety to ensure compliance with BMS procedures and regulatory requirements.
- B.S., M.S. with a minimum of 5 years relevant industrial experience or PhD in chemistry or chemical engineering with 3 years of relevant industrial experience in a GMP environment.
- Experience in process development and/or pilot plant operations with demonstrated strength in project management and problem solving.
- Strong technical skills (process development and scale up, chemical processing equipment, plant operations) with proficient understanding of pharmaceutical drug development process
- Up to 10-15% percent domestic and/or international travels annually.
- Essential to success are the ability to build strong working relationships with internal and external partners, to apply cooperation principles and ways of working in a matrix environment, and to lead matrix teams. Demonstrated strength in all modes of communication (presentation, oral and written) and the ability to effectively manage activities across a complex portfolio of projects with minimal supervision are essential