Specialist, Environmental Monitoring Team Lead

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.

This position will report to the Manager of MSS-EM.  The Lead will work with a team of MSS-EM Samplers to ensure that routine/non-routine Environmental Monitoring (EM Sampling) in the GMP areas of Summit West CAR-T Manufacturing and Warehouses areas is performed. The MSS-EM Lead will provide oversight for collection of environmental monitoring samples for the controlled, non-classified areas as well as controlled non-aseptic and aseptic processing areas of manufacturing. 

Shift Available:

• Sunday - Thursday, Onsite Morning Shift, 4 a.m. - 12 p.m.

Responsibilities:

• Accountable to ensure completion of EM Monitoring Sampling tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP’s) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).

• Take personal responsibility to work safely and drive accountability and process for team members to do the same. Perform regular safety Gemba walks, identify the hazards associated with team’s work and demonstrate safe behavior when operating and maintaining equipment to prevent injuries or incidents.

• Lead and ensure EM sampling responsibilities are performed in accordance with the organization’s policies, procedures, state, federal and local laws.

• Drive compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.

• Drive completion, adherence to training requirements and assess appropriate level of training for team members, completes their training plan on time and ensures proficiency and qualification to perform the production tasks.  Monitors team training due dates and maintain the trained status of all team members by ensuring appropriate time is allocated to training activities.

• Lead will collaborate with Supply Chain Scheduling, Abecma, Breyanzi, Media Prep and Warehouse Ops Management to ensure timely and accurate EM sampling of GMP areas.

• Scheduling EM Sampling for routine EM every week for the team.

• Lead will serve as the liaison to the QC teams for testing of EM samples.

• Communicate effectively with Manufacturing Operations peers, cross-functional peers and management.

• Assist in troubleshooting and solving problems with various functional groups to drive efficiency and productivity.

• Lead EM Sampling Team to perform Environmental Monitoring on a routine and non-routine basis under Static and Dynamic conditions for all S12/S16 and S6A GMP manufacturing and associated warehouse areas.

• Responsible to be the Point of Contact and Communication with Facilities and other functional groups during planned or unplanned events like Air Reversals to be able to pull together the team to perform EM Sampling for Suite Release. Under the guidance of management, support special project work and continuous improvement initiatives for MO.

• Perform Environmental Monitoring Sampling steps to maintain hands-on expert knowledge of each Unit Operation, role model good execution and behaviors for team members and if necessary, able to backfill execution resources to meet the production schedule.     <