Senior Director, Manufacturing Science & Technology (MSAT), Cell Therapy

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us

• Foster a culture of compliance and strong environmental, health, and safety performance
• Build and maintain inspection readiness and actively support regulatory inspections, interface with regulatory authorities as required to support pre-license inspections and subsequent routine GMP inspections
• Build and evolve the organizational structure to maximize productivity and organizational success in the design, construction, validation and operation of the Summit Cell Therapy manufacturing facility. Select and develop a well-trained, motivated and informed staff.
• Develop, implement and monitor metrics to track and manage completion of objectives and projects
• Allocate resources to ensure supply plans are met within the planned schedule and budget
• Ensure employees have the resources needed to meet or exceed their goals; ensure adequate systems, procedures, personnel and equipment are in place.
• Work with key partner organizations such as Manufacturing, Quality, and Facilities & Engineering to build and maintain efficient systems that support the safe, successful and compliant startup, technical transfer and operation of a clinical and commercial Cell Therapy manufacturing facility.
• Lead a Validation team that will:
  • Provide technical leadership for the commissioning, qualification and validation of the Summit Cell Therapy manufacturing facility with a focus on clean room technology and Aseptic Qualification
  • Partner with Summit Facilities and Engineering to establish systems that will maintain a compliant, validated state for the Manufacturing facility
• Lead a team of Automation engineers that will:
  • Manage stand-alone manufacturing equipment.
  • Support the design, build, deploy, validate and support both automation and execution systems (Delta V, Syncade, MES, EBR, OSI Pi Data historian, etc.) in a regulated pharmaceutical manufacturing environment.
  • Lead the life cycle management and integration of electronic GMP manufacturing systems
• Lead the Manufacturing Support and Process engineering function with a focus on:
  • Provide technical leadership for the design, construction, validation and operation of the Devens Cell Therapy manufacturing facility.
  • Building and maintaining systems to continuously monitor, analyze, and optimize the end-to-end process performance
  • Anticipating and permanently resolving issues that may arise during production
  • Partnering with QA and Manufacturing to ensure efficient and compliant cGMP systems to support manufacturing, including change control, investigations, etc.
• Lead the Operations Investigation team:
  • Provide technical support to site operations through determination of root cause investigations
  • Determination of suitable CAPA to prevent recurrence of events
  • Partnering with QA, Manufacturing, Supply Chain, Facilities and Engineering to ensure efficient and compliant cGMP systems to support manufacturing, including change control, investigations, etc.
• Monitor the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management
• Working with Global MS&T groups, execute/implement standardized CTDO practices and Life Cycle Management projects in manufacturing in alignment with the overall network plans.
• Maintain and understanding of current industry trends and regulatory standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
• Create an environment of teamwork, open communication, and a sense of urgency, lead as a change agent to promote flexibility, creativity, and accountability
• Drive strong collaboration within the plant and across the network
• Build trust and effective relationships with peers and stakeholders
• Deliver business results through timely and quality decision making and advice
• Promote a mindset of continuous improvement and problem solving

• Bachelor’s degree in relevant science or engineering discipline, advanced degree in a relevant science or engineering discipline preferred
• 12+ years of work experience in the biopharmaceutical or related industry. Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T or Technical Development.
• Minimum 10 years of direct experience in GMP environment and manufacturing site-based MS&T experience
• 8+ years of people management experience
• Expert knowledge of cGMP’s and multi-national biopharmaceutical/cell therapy regulations
• Deep knowledge of facility/clean room design, process, equipment, automation, and validation
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
• Demonstrated ability to build people, processes, and technology in a complex, global, and technical organization
• Experience leading regulatory inspections
• Experience utilizing a Quality Management System (QMS)
• Hands-on experience with and broad knowledge of single-use technologies, closed systems, and cold chain/cryogenic technologies
• Experience leading teams of manufacturing technical experts, engineers and/or scientists.
• Possess strong verbal/written communication skills and ability to influence at all levels
• Ability to think strategically and to translate strategy into actions
• Ability to prioritize and provide clear direction to team members in a highly dynamic environment
• Experience with Operational Excellence and Lean Manufacturing, Green Belt or Black Belt a plus.

BMSCART

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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

COVID-19 Information
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.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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