Senior Director, Drug Product Manufacturing Operations

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.

OBJECTIVE OF POSITION

Leads the entire Manati Site Drug Product Manufacturing Operation (Sterile, Non-Sterile and Warehouse Operations) by transpiring a clear vision, defining the strategy for manufacturing areas and by influencing and empowering team leaders on effective communication and talent development. Ensures alignment of manufacturing objectives with GPS DPO strategic plan ensuring efficient and compliant operations. Complies with planning requirements, supply chain needs for commercial and clinical products overseeing alignment with planning scheduling and warehouse (receiving and shipping) efficient management. Manages effectively operations budget to achieve plant financial objectives. Drives manufacturing operational performance by developing and retaining a robust talent pool, driving production process improvement, which consistently delivers on site metrics, critical capabilities, Operations Strategy and Operating Plan. 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. Assures compliance with Company policies and procedures, and with local, state, federal and international government regulations.

MAJOR DUTIES AND RESPONSIBILITIES

• 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.
• 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.
• Ensures alignment of manufacturing objectives with GPS DPO strategic plan ensuring efficient and compliant operations.
• 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 fixe d) in order to achieve plant and area budget goals, and takes action proactively as required.
• Ensures Production Planning and Scheduling complies with planning requirements and supply chain needs for commercial and clinical products.
• Provides management and technical support to high volume production lines for the successful execution of site’s business plan and strategy.
• Oversees that area equipment is well maintained, including but not limited to calibrations and preventive maintenances, in or der to achieve optimal operational performance while maintaining regulatory and compliance requirements.
• Partners with Quality, MS&T, Engineering and PMO to achieve sterile strategic growth product projects milestones.
• Supports Risk Management initiatives and proper in -process controls.
• Supports all technology transfer activities, equipment qualification, process validation, troubleshooting clinical lots production, and process optimization by pro viding the necessary resources and process expertise.
• 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.
• 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.
• 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.
• Ensures and enforces quality control mechanisms for process control and area regulatory compliance.
• Establishes and communicates area performance monitoring metrics for process, cost and quality control.
• Promotes a safety culture by enforcing compliance with procedures to prevent accidents and expedites resolution of area potential safety and security issues.
• Participates as a key contact of the parenteral and non-sterile operations in internal and external audits.
• Maintains control of all environmental issues in manufacturing areas. Ensures the compliance with federal and local regulator y agencies (e.g., OSHA, EPA, FDA, DEA, etc.)
• Assures the correct handling of hazardous waste, as required Performs as back up in the absence of the General Manager.
• 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.
• Manages area regulatory affair reports, customer complaints, and area exception reports (e.g., Quality Investigation Reports, Quality Complimentary Reports, Change Request Forms, etc.).
• Provides the necessary resources to audit manufacturing process records of the daily production as well as other daily paperwork and support processes.
• 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.
• Assesses resource needs for short and long-term talent demand and timely generates and completes personnel requisition forms as required by the manufacturing workload.
• Exemplifies and promotes BMS Core Behaviors and Culture of Excellence, facilitating teamwork, providing coaching and feedback, as needed.
• Performs as back up to General Manager
• Validated ability to collaborate with business leaders to develop, implement and sustain change interventions that enable culture shift and achievement of business goals.
• Influencing skills demonstrating ability to build and sustain excellent relationships at multiple levels in the organization/network. Uses relationships not only to gain a better understanding of the business needs, but also to strategically accomplish goals.
• Ensures timely and transparent communications to promote engagement and understanding amongst employees and improve organizational trust and credibility and shares best practices for promoting a positive work environment.
• Works with the Manati Leadership Team to communicate and implement company initiatives that enhances the culture and creates accountability for leaders to nurture an inclusive team environment.
• Drives effective methods for gathering employee feedback within the Operations team, keeping a pulse on the employee experience, leader effectiveness and the employee value proposition. Creates action plans to support employee engagement and fosters a continuous improvement mindset at the department and company level.

KNOWLEDGE/SKILLS REQUIRED:

• BA/BS in Chemistry, Biology, Pharmacy, Biotechnology or Chemical Engineering. Master or PhD degree preferable.
• At least 10 years’ experience in a Parenteral Manufacturing and Lyophilization process supervisory / managerial position; experience in Sterile Operations is required.
• Thorough knowledge of cGMP regulations 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.
• Strategic critical mindset to help solve potential operational and / or compliance problems that could interrupt product supply to the market.
• Significant record of accomplishment of Operations within manufacturing arena.
• 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.
• Demonstrated knowledge of product standards and budget control.
• Proven people influencer (inspires, listens, communicates directly and assertively, providing prompt feedback and coaching to correct and improve performance related issues).
• Proven experience in developing highly engaged teams and fostering a strong organizational culture within the team and across the organization.
• English required; bilingual English & Spanish is a plus

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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