Senior Director, MS&T (Manatí, PR)

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.

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.

The incumbent leads the Manufacturing Science and Technology organization at the site for existing and new sterile products, acting as main technical steward for the site and primary functional leader. This role has additional focus on the site’s process engineering, the lead investigator team and non-sterile operations support. Accountable for the transfer, validation, optimization and daily support of manufacturing, including both aseptic processing and secondary packaging (devices) for five commercial biologic products distributed across the globe. Responsible for the effective introduction and robustness of the processes and related equipment of products transferred from Research and Development, other BMS sites, or business partners, while meeting or exceed established timing targets and business plans. Must comply with all relevant EH&S requirements, Security guidelines and current Good Manufacturing Practices.

• Primary technical leader at the site, assuring that current and upcoming manufacturing processes are robust and efficient. Manages the overall Technical Transfer program at the site and ensures effective technical input regarding equipment and materials is provided early in the TT process.
• Oversees the ‘end to end’ technical success of process transfers and new product launches, effectively integrating technical stewardship with manufacturing activities and priorities established by BMS, while remaining compliant with any current regulations.
• Oversees the validations program to assure high assurance of compliance to regulatory requirements and the efficacy, repeatability and robustness of manufacturing processes and associated equipment.
• Oversees Process Engineering as part of Tech Transfer/New Product launch activities and routine process support.
• Oversees technical process support activities, leading to successful on time resolution of investigations, and improvement of the manufacturing processes, including equipment. This includes site activities for optimization of new and existing manufacturing processes, while championing and leveraging the robustness program.
• Co-sponsors the BMS investigation program at the site. Supports the plant in process investigations and /or directs process and other complex investigations.
• Accountable for the identification of best practices in our industry related to validation, technology transfers, sterile processing technology, investigations and process support to manufacturing. Achieves effective introduction of best practices to the site and the network to enable a competitive advantage.
• Represents MS&T internally and externally to BMS, and influences the organization with authority on formulation, processing, filling and packaging of Parenteral products and other relevant areas.
• Drives effective working relationships with other functional organizations, such as Quality, Operations, Engineering, Global Regulatory Sciences, the Microbiology Center of Excellence, and others, both internally and externally to the site. Promotes a collaborative and inclusive environment while driving a culture of high performance and mutual accountability.
• In collaboration with other functions, ensures that effective systems and business processes are in place at the site to assure compliance to corporate guidelines for Technology Transfer, Validations, Raw Material Qualification and other relevant areas. For example, supporting finance to develop and control project budgets for the site and the department.
• Leads, motivates, mentors and develops team members to meet or exceed plant and company goals and objectives.
• Establishes an effective technical and leadership development program for the MS&T site organization. Identifies high potentials and provide leadership to assure their development and incorporation in succession plans, based on business and individual needs.

• Minimum of Bachelor's degree in relevant science or engineering discipline (chemistry, pharmacy, biology, chemical engineering or a related pharmaceutical science). Masters or Doctoral degree preferred.
• 16+ years of experience in the biopharmaceutical or applicable industry in product and process development and commercialization in a global environment.
• Expert in biologics/sterile/liquid drug product development and commercialization, process engineering, aseptic processing (Lyo and RTU), fill, finish, inspection and packaging operations.
• Experienced in sterile drug product Technology Transfer, scale up and technology evaluation.
• Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals in commercial manufacturing.
• Thorough understanding of regulations, familiarity of regulatory environment and industry trends for sterile drug products, including combination products.
• Working competency of Statistical Process Control, Computer Modelling, Data Analytics and related tools.
• Comprehensive experience managing and leading diverse teams and interfacing with multiple stakeholders.
• Excellent communication and presentation skills.
• Strong understanding of project management systems and tools and six sigma green/black belt certification are desirable.

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.

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.