Associate Director, Product Technical Steward, Cell Therapy Technical Operations position at Bristol Myers Squibb.| United States Of America

Bristol Myers Squibb Associate Director, Product Technical Steward, Cell Therapy Technical Operations

Experience: 12-years

Pattern: full-time

Country:

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Associate

Devens - MA - ..........United States Of America

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. 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 . The Associate Director, Product Technical Steward, Cell Therapy Technical Operations (CTTO) is highly cross-functional and challenging, involving leadership across all sites of Drug Product manufacture for the designated product. In this role the Technical Steward will: Develop strategy for the product franchise by representing Drug Product on product strategy teams and leading a cross-functional team that manages the Drug Product technical project portfolio. Be the primary owner of the Drug Product process, and leads or participates in process validation, regulatory filings, regulatory inspections and responses, technology transfers, troubleshooting, change management, process monitoring and robustness, continuous improvement, and other initiatives. Interact regularly with product development to ensure process readiness for commercialization, assess resources required, communicating progress and risks, and presenting timelines and strategies for endorsement. Represent the Drug Product manufacturing process in regulatory interactions such as inspections and other meetings. Work with Drug Product manufacturing site teams to troubleshoot manufacturing issues and develop process improvements. Collaborate closely with analytical, quality, regulatory, operations, development, supply chain, program strategy, third-party manufacturing, and manufacturing sciences to drive the franchise strategy. The position requires resolution of complex problems through strong leadership of cross-functional teams to meet product quality, schedule, and cost objectives. Key Responsibilities: Strategic Planning: Defines strategy for the product franchise by representing Drug Product on product strategy teams and leads a cross-functional technical team that creates and governs the Drug Product technical project portfolio for the designated product. Technical Oversight: Collaborate with process development and analytical development to ensure early pipeline assets have a robust process. Key Deliverables: Primary owner of the Drug Product process for the designated product. Technical content and strategy across tech transfers, process validation, technical reports, data analysis, process monitoring, change control and implementation, product comparability and escalated support of technical/scientific process and analytical issues Regulatory & Documentation: Provide technical content for documents such as PPQ protocol or comparability assessments, author content for regulatory submissions and annual product quality review, present technical strategies during major health authority interactions and inspections. Cross Functional Leadership: Collaborates closely with analytical, quality, regulatory, operations, development, supply chain, strategy, third party manufacturing and manufacturing sciences roles to drive the brand strategy and prevent supply disruptions. Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites. Oversees implementation of lifecycle management projects and responsible for gaining consensus on change implementation strategies that ensure robust Drug Product supply. Qualifications & Experience : B.S/MS/PhD in Chemical Engineering or Biology, Chemistry, Biochemical (Life Science) with 12+ years of relevant experience in the biopharmaceutical company with most of that experience demonstrating progression of technical leadership responsibilities and scope. Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T (Technical operations) or Technical Development. Should have excellent communication skills and be able to strategically influence the direction of the company in the scope areas mentioned above. Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for Drug Product manufacturing and processing equipment, manufacturing support and technology transfer. Ability to define the right processes for the team’s maturity level, balancing agility and discipline. Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools strongly preferred. Ability to assess risk and develop contingency plans for process risks. Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities. Detail oriented with excellent verbal and written communication skills. Strong interpersonal and leadership skills to work with teams in different functions and organizations. Experience leading regulatory inspections regarding tech transfer, validation and extensive knowledge of regulations, current industry practices. Should have demonstrated the skill to lead large, complex technical organizations with a global scope and build processes, and technology in a growing organization. Proven 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 Additional preferred qualifications: 2-3 years of experience in cell therapy process development and or manufacturing. Combination of experience in process development, MS&T and quality, experience with manufacturing automation systems/platform. This position will require up to 20% travel. #LI-Hybrid BMSCART GPS_2025 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. Compensation Overview: Devens - MA - US: $178,420 - $216,197
Madison - Giralda - NJ - US: $166,740 - $202,055
 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. 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 a supportive culture, promoting global participation 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 an 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. Supporting People with Disabilities 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. Candidate Rights 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/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1598138 : Associate Director, Product Technical Steward, Cell Therapy Technical Operations

Associate Director, Product Technical Steward, Cell Therapy Technical Operations job opportunity at Bristol Myers Squibb.

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