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. This is a potential expected high level need in Puerto Rico. The requisition is not open yet but should be soon. Parenteral or Sterile drug product experience is a MUST Oversees Manatí Manufacturing Operations including the entire Parenteral Manufacturing areas (Parenteral Vial, Parenteral Syringe, Par Lyo areas), Non Sterile areas including Inspection Operations, Packaging Operations, Packaging Technology Medical Devices, Oral Solid Dose Operations and Manufacturing Process Improvement area. Maintains a production schedule that meets customer needs in compliance with company policies, cGMP’s and all applicable regulatory compliance requirements. Provides leadership and direction to all Manati Manufacturing product portfolio and is the key driver and contact point for all of the Manati Manufacturing Operations strategic initiatives and projects. The incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. MAJOR DUTIES AND RESPONSIBILITIES: 1. Defines the strategy for manufacturing areas to ensure efficient and compliant operations. 2. Manages effectively the Drug Operations people and budget resources to achieve plant objectives. 3. Complies with all planning requirements and supply chain needs for commercial and clinical products. 4. Provides management and technical support to high volume production lines for the successful execution of Manati business plan and strategy. 5. Ensures 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. 6. Partners with MT, Engineering and PMO to achieve sterile strategic growth product projects milestones. 7. Supports the Risk Management initiative and proper in-process controls. 8. Supports all technology transfer activities, equipment qualification, process validation, troubleshooting clinical lots production, and process optimization by providing the necessary resources and process expertise. 9. Supports Productivity initiative programs by identifying efficiencies in the Operational areas and providing resources to support Productivity teams. 10. Embraces and champions OpEx tools to improve yields, efficiency and costs. 11. Drives the operational performance of the Manufacturing section by developing and retaining a robust talent pool which consistently delivers on site metrics, critical capabilities and Operations Strategy and Operating Plan. 12. 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. 13. Ensures and enforces quality control mechanisms for process control and area regulatory compliance. 14.Ensures optimal training to develop the abilities, knowledge and skills needed to monitor and improve adequate Quality standards. 15. Establishes and communicates area performance monitoring metrics for process, cost and quality control. 16. Participates as a key contact of the parenteral and non-sterile operations in internal and external audits. 17. Supports / resolves area safety and security issues. 18.Ensures the creation and revision of SOP’s, WFP’s special test protocols and procedures to assure compliance with cGMP’s, Company policies / procedures and documentation practices. 19. Manages area regulatory affair reports, customer complaints, and area exception reports (e.g., Quality Investigation Reports, Quality Complimentary Reports, Change Request Forms, etc.). 20. Provides the necessary resources to audit manufacturing process records of the daily production as well as other daily paperwork and support processes. 21. 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. 22. 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. 23. Generates and completes personnel requisition forms as required by the manufacturing workload. 24.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.) 25. Assures the correct handling of hazardous waste, as required Performs as back up in the absence of the General Manager. 26. Promotes and model the BMS Core Behaviors and Culture of Excellence, facilitating teamwork, providing coaching and feedback, as needed. 27. Performs as back up to General Manager. 28. Promotes and models the BMS Core Behaviors and Culture of Excellence, facilitating teamwork, providing coaching and feedback as needed KNOWLEDGE/SKILL BA/BS in Chemistry, Biology, Pharmacy, Bio-Technology or Chemical Engineering. Master or PhD degree preferable. Ten (10) years experience in a Parenteral Manufacturing and Lyophilization process supervisory / managerial position. Thorough knowledge of cGMPS’s and Federal and State regulatory requirements. In depth understanding of the Parenteral Aseptic Processes (Compounding, Filling and Lyophilization). Competent knowledge in Isolation technology equipment, operation and applicable regulations. Demonstrated experience in OSD and packaging technologies. Proficiency in product transfer process, root cause analysis and new product development process. Demonstrated knowledge of product standards and budget control. Significant track record of Operations accomplishments within manufacturing arena. Strategic critical mindset to help solve potential operational and / or compliance problems that could interrupt product supply to the market. Strong people skills (communicates directly and assertively, providing prompt feedback and coaching to correct and improve performance related issues). Experience in writing technical reports and T&E’s, executive summary type presentations to senior management and technically detailed presentations to specialized technical groups such as Technical Services, Supply Chain, Engineering and QC/QA
