API Project Execution Lead
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Work as part of a cross-functional matrix team to develop program drug substance supply plans and ensure successful manufacture of active pharmaceutical ingredients, chemical intermediates and specialty materials.
Accountable for ensuring drug substance is available to meet clinical and non-clinical (formulation development, toxicology, stability studies, etc.) program requirements across assigned R&D pipeline products.
Key responsibilities include:
- Develop, maintain, and execute multi-year drug substance manufacturing strategy and supply plans for assigned portfolio programs from ECN through validation that ensure material and development needs across the organization are met. Development of strategies will include options analysis and appropriate risk mitigation strategies.
- Accountable for development and execution of detailed campaign timeline that includes key sourcing and manufacturing milestones and incorporates CPD Project team and External Partner Management (EPM) requirements for successful sourcing and execution.
- Provide assessment of supplier's ability to deliver against program requirements to DS Operations and Supply management and EPM to enable informed supplier selection process.
- Oversee manufacturing at external vendors to ensure successful execution at external manufacturing sites and work with internal and external partners to adapt as changes occur. Responsible for project management, logistical support, and coordination between suppliers.
- Ensure on time, on quality delivery of drug substance.
- Uses a cooperative approach with CPD Project teams, DSOS Subject Matter Experts (safety, etc.), External Partner Management, and Quality to manage interactions with suppliers and deliver against the scope of work while ensuring that all campaign goals are met (safety, quality, data packages, etc. ).
- Represent drug substance supply at key internal and external interfaces - CMC Team, etc.
- Responsible for regular communication of project status to CPD management and other key stakeholders. Escalate and resolve issues as appropriate.
- Develop and maintain tools to aid in oversite of project execution, portfolio management & governance.
- Ensure project to project consistency at external partners.
- 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 analytical development, process development and/or pilot plant operations with demonstrated strength in project management and problem solving.
- Strong technical skills (analytical development, 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 travel 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.
- Must be able to synthesize requirements from a large number of stakeholders into a workable strategy, and present different options and recommendations for consideration to management.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.