API Project Execution Lead
About the Job
As API Project Execution Lead, you will 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 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, GPS, R&D Quality, and Development teams to manage interactions with suppliers and deliver against the scope of work.
Leads the first line issue resolution and problem solving to achieve the right outcomes.
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 8 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
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