Senior Specialist, Investigations, Cell Therapy - Devens, MA

Military Spouse Corporate Career Network•Devens, MA

5d•Onsite

About The Position

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. 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.

Requirements

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