Director, Investigations in Summit, NJ

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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Director of Investigations supports the production of personalized cell therapy products for both global clinical trials and commercial supply.  Leads a team that provides compliance and investigations support to the Summit Cell Therapy facility through delivery of robust deviation investigations.  Provides technical and continuous improvement support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

The organization being supported is a 24x7x365 manufacturing facility. 

Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in S12.  This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MSAT.

This position is based in Summit, NJ.  Global travel up to 10% of time may be required. 

Shifts Available:

Monday – Friday, Standard Working Hours, Onsite

Responsibilities:

• Providing direct and indirect supervision of a team of investigators
  • Supports identification and facilitation of resolution of obstacles to timely completion
• Establishing and reporting metrics for investigation activities
• In collaboration with Quality Assurance, providing oversight of Investigations management to ensure timely and compliant closure
• Representing the Site MS&T Investigations team in cross-functional forums
  • Presents investigation findings to key stakeholders and site management
• Performing review and approval of site and department SOPs
• Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; Actively supporting regulatory inspections
• Interacting with other teams including Process Support/Engineering and Manufacturing Support, Manufacturing Operations, Quality Assurance, Supply Chain Operations, Site Engineering, and Quality Control
  • Leads and participates in cross-functional investigation teams/stakeholders
• Staying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities.
  • Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste

Leadership:

• Create an environment of teamwork, open communication, and a sense of urgency
• Lead as a change agent to promote flexibility, creativity, and accountability
• Cascade organizational strategic goals and objectives that are linked to the overall company strategy
• 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
• Foster a culture of compliance and strong environmental, health, and safety performance
• Promote a mindset of continuous improvement, problem solving, and prevention

Knowledge and Skills:

• Expert knowledge of cGMP’s and multi-national biopharmaceutical/cell therapy regulations
• Experience in cGMP investigations utilizing formal Root Cause Analysis tools strongly preferred
• 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
• Experience with SOPs, cGMPs and the know how to work within a regulatory environment required
• Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
• Experience working with external parties and/or leading cross-functional teams
• Proficient in basic project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment are required
• The candidate has experience in problem solving ability, experience with manufacturing systems and equipment, good interpersonal, oral and written technical communication skills are essential.
• 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

Basic Requirements:

• Biochemical, Chemical, Biomedical Engineering or Cell Biology/Immunology discipline with
  • B.S. with 16 years of relevant experience
  • M.S with 14 years of relevant experience
  • Ph.D. with 10 years of relevant experience
• 6 or more years of people management experience
• 6 or more years of manufacturing support or related experience in the biopharmaceutical industry
• Experience leading investigations, performing root cause analysis, and identifying corrective and preventative actions required
• Experience in cell therapy, biologics, or vaccine manufacturing/support required
• Experience in building and growing an organization into a high performing team
• Experience with Operational Excellence and Lean Manufacturing is a plus
• Robust experience with RCA and process optimization

Working Conditions:

The incumbent will be required to gown to access classified manufacturing areas. 

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments 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 cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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