API Project Execution Lead

Bristol-Myers Squibb New Brunswick, NJ

About the Job

Description:

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.


Qualification:

Qualifications

  • 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