Associate Director, CAR-T Process Engineering, Systems and Technology Support

Bristol Myers Squibb • Devens, MA

7d • Onsite

About The Position

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. 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 Associate Director, CAR-T Process Engineering, Systems, & Technology Support leads a team of scientists and process and/or systems engineers that support clinical and commercial cell therapy manufacturing. This team is responsible for product and process monitoring, troubleshooting, and improving clinical and commercial cell therapy unit operations and process systems records. This position reports to the Director of Process Engineering within the site Manufacturing Sciences and Technology organization. Shifts Available: TBD

Requirements

• 12+ years relevant experience in cGMP environment for Biologics/CMC/Vaccines
• 4+ years managing direct reports with varying levels of experience
• Ability to prioritize and provide clear direction to team members in a highly dynamic environment
• Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
• Experience with internal and health authority audits
• Excellent verbal/written communication skills and ability to influence at all levels
• Ability to think strategically and to translate strategy into actions
• BS in Engineering or Biotechnology related field.

Nice To Haves

• Advanced degree is a plus.
• Subject Matter Expert in cell therapy and/or sterile manufacturing processes, with demonstrated ability to troubleshoot issues and provide technical support.
• Experience with Operational Excellence and Lean Manufacturing is highly desired with experience leading process technology transfer and validation is a plus.
• This position may require flexibility to travel up to 10 % of time

Responsibilities

• Leads a team of process subject matter experts that support clinical and commercial cell therapy manufacturing operations.
• Provides on call, 24/7 manufacturing support for clinical and commercial production for run the business and continuous improvements or roll out of required system and process updates in alignment with the network
• Establishes and maintains the site’s process monitoring program.
• Collaborates with other sites and global teams on the continued process verification program and brand APQR.
• Identify, prioritize and drive continuous improvements that reduce safety risks, operational costs, lead times, scrap, and discrepancy rates across all aspects of production.
• Promote problem identification and the creation of meaningful solutions through a culture of proactive problem prevention
• Reviews and approves manufacturing batch records and procedures
• Reviews and approves process investigations and change controls
• Engage and align CMC lifecycle strategy and execution with stakeholders
• Influence and review technical content within the CMC sections of regulatory filings
• Build and cultivate for the team and site a culture of maintaining a constant state of inspectional readiness
• Function as a primary contact for internal and Health Authority audits and driving audit observation corrective actions to closure
• Serve as MS&T representative on cross-functional and multi-site teams
• Build and maintain effective collaborative relationships across the site and network, influencing site and network product/process life cycle programs
• Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
• Exercise sound judgment and flexibility while adapting to rapidly changing priorities, challenging situations, and deadlines needed to meet business objectives
• Coach and mentor team members thereby enabling their development and career growth
• Establish and track departmental performance metrics

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees