Manager, Investigations, Cell Therapy in Devens, MA at BristolMyers Squibb
Devens, MA 01434, USA -
Full Time


Start Date

Immediate

Expiry Date

03 Dec, 25

Salary

127360.0

Posted On

03 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Lean Manufacturing, Biologics, Strategy, Product Complaints, Root, Communication Skills, Cell Therapy, Biochemistry, Operational Excellence

Industry

Hospital/Health Care

Description

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 Manager, Investigations, Cell Therapy provides investigation leadership and support to the Devens Cell Therapy Manufacturing Facility. The Manager will perform complex root cause analysis, work with stakeholders to identify corrective and preventative actions, facilitate impact assessments, ensure the Manufacturing Science & Technology team is audit ready, facilitate Annual Product Quality Reviews, and investigate product complaints.

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Responsibilities
  • Conducting and managing the resolution of complex/multi-functional root cause investigations, including impact assessments, CAPAs, and product complaints 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
  • Staying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities.
  • Coaching and mentoring of colleagues on Investigation Program fundamentals and best practices
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