Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. 1. Leads the Manati Site Drug Product Manufacturing Operation by transpiring a clear vision, defining the strategy for manufacturing areas and by influencing and empowering team leaders on effective communication and talent development. 2. Incumbent is expected to be a champion of our organizational culture and values, and recognition. This also includes involvement in hiring, mentorship and development of remarkable talent. 3. Ensures alignment of manufacturing objectives with GPS DPO strategic plan ensuring efficient and compliant operations. 4. Manages effectively manufacturing operations budget to achieve plant financial objectives. Participates in the preparation of the budget for the production related accounts for manufacturing area and; manages effectively the area budget by evaluation of monthly expenses (variable and fixed) in order to achieve plant and area budget goals, and takes action proactively as required. 5. Ensures Production Planning and Scheduling complies with planning requirements and supply chain needs for commercial and clinical products. 6. Provides management and technical support to high volume production lines for the successful execution of sites business plan and strategy. 7. Oversees that area equipment is well maintained, including but not limited to calibrations and preventive maintenances, in order to achieve optimal operational performance while maintaining regulatory and compliance requirements. 8. Partners with Quality, MS&T, Engineering and PMO to achieve sterile strategic growth product projects milestones. 9. Supports Risk Management initiatives and proper in-process controls. 10. Supports all technology transfer activities, equipment qualification, process validation, troubleshooting clinical lots production, and process optimization by providing the necessary resources and process expertise. 11. Supports Productivity initiatives by enabling production process improvement resources, identifying efficiencies in the Operational areas and providing resources to support Productivity teams. Embraces and champions OpEx tools to improve yields, efficiency and costs. 12. Drives operational performance by developing and retaining a robust talent pool, overseeing optimal training to develop their abilities, knowledge and skills, which consistently delivers on site metrics, monitoring and improving Quality standards, Operations Strategy and Operating Plan. 13. Provides full support to production scheduling by assuring the coordination of the manufacturing Leaders with the area Planner to organize and comply with daily production goals. 14. Ensures and enforces quality control mechanisms for process control and area regulatory compliance. 15. Establishes and communicates area performance monitoring metrics for process, cost and quality control. 16. Promotes a safety culture by enforcing compliance with procedures to prevent accidents, and expedites resolution of area potential safety and security issues. 17. Participates as a key contact of the parenteral and non-sterile operations in internal and external audits. 18. Maintains control of all environmental issues in manufacturing areas. Ensures the compliance with federal and local regulatory agencies (e.g., OSHA, EPA, FDA, DEA, etc.) 19. Assures the correct handling of hazardous waste, as required Performs as back up in the absence of the General Manager. 20. Ensures the creation and revision of SOPs, WFPs special test protocols and procedures to assure compliance with cGMPs, Company policies / procedures and documentation practices. 21. Manages area regulatory affair reports, customer complaints, and area exception reports (e.g., Quality Investigation Reports, Quality Complimentary Reports, Change Request Forms, etc.). 22. Provides the necessary resources to audit manufacturing process records of the daily production as well as other daily paperwork and support processes. 23. Provides direction to the Manufacturing Alignment Team and leads the Investigation Management Process for critical deviation events as well as the systematic approach to reduction of Quality events for the Manufacturing areas. 24. Assesses resource needs for short and long-term talent demand and timely generates and completes personnel requisition forms as required by the manufacturing workload. 25. Exemplifies and promotes BMS Core Behaviors and Culture of Excellence, facilitating teamwork, providing coaching and feedback, as needed. 26. Performs as back up to General Manager 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 the resources to pursue their goals, both at work and in their personal lives. SDL2017
