Senior Specialist, Investigations, Cell Therapy Devens, MA

ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.

Challenging. Meaningful. Life-changing. Those arent 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. Youll 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 theres 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:

Monday Friday 8am 5pm

Responsibilities will include but are not limited to the following:

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
Knowledge Skills & Abilities:

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 cGMPs 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