Senior Specialist, Investigations, Cell Therapy

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 rich in diversity. 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.

The Senior Specialist, Investigations provides investigation leadership and compliance support to the Devens Cell Therapy Manufacturing Facility.  The Devens Cell Therapy Manufacturing Facility is a new facility, and the Senior Specialist will perform root cause analysis, work with stakeholders to identify corrective and preventative actions, and facilitate impact assessments.  The Senior Specialist reports to the Senior Manager, Investigations & Compliance within the site Manufacturing Science & Technology department.

Responsibilities 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

• Collaboration with many different groups/organizations as a Lead Investigator including Process Engineering and Support, Engineering and Facilities, Manufacturing Operations, Quality Assurance, and Quality Control

• Proactive management of 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 maintains permanent inspection readiness; Active support of regulatory inspections

• Staying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities.

Qualifications and Education 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

• Experience utilizing root cause analysis/OPEX tools and identifying corrective and preventative actions is required

• 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

WORKING CONDITIONS (US Only):

Position may require working in Clean-Room manufacturing environment approximately 15% of the time.  Remainder of work is performed in an office environment.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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