Senior Specialist, Investigations, Cell Therapy

Bristol Myers Squibb • Devens, MA

5d • $88,190 - $106,863 • Hybrid

About The Position

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.

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
• 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

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

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.
• 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: Senior