Senior Specialist, Investigations, Cell Therapy in Devens, MA

Bristol Myers Squibb • Devens, MA

23h • 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 Senior Specialist, Investigations, Cell Therapy provides investigation leadership to the Devens Cell Therapy Facility. The Senior Specialist will perform root cause analysis, work with stakeholders to identify corrective and preventative actions, and facilitate impact assessments. Shifts Available: TBD

Requirements

• Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline plus 2-4 years’ experience in biopharmaceutical operations, or its equivalent is required

Nice To Haves

• Experience utilizing root cause analysis/OPEX tools and identifying corrective and preventative actions preferred
• Experience with Operational Excellence and Lean Manufacturing is a plus
• Experience in cell therapy, biologics, or vaccine manufacturing/support desired
• Experience in cGMP’s and multi-national biopharmaceutical/cell therapy regulations desired
• Excellent verbal/written communication skills and ability to influence at all levels
• Ability to think strategically, and to translate strategy into action
• Ability to prioritize and provide clear direction to team members in a highly dynamic environment

Responsibilities

• Conducting and managing the resolution of root cause investigations, including impact assessments, and CAPAs as a Lead Investigator
• Collaborating with many different groups/organizations as a Lead Investigator including Process Engineering and Support, Engineering and Facilities, Manufacturing Operations, Quality Assurance, and Quality Control
• Proactively managing the progression of investigations and CAPAs to timely and compliant closure per established KPIs
• Presentation of investigation findings to key stakeholders and site senior management
• Use of Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste
• Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; Actively supporting regulatory inspections

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