Associate Director, Cleanroom Operations

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.

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 Associate Director, Cleanroom Operations, leads a team of Senior Managers, Managers, Team Leads and Material Handlers that interface with GMP cleaning and EM sampling partners responsible for all processes associated with GMP cleaning & EM Sampling within CAR T clinical and commercial operations in a several cGMP multi-cleanroom suite as well as control/enhancement of CNC/Cleanroom/Transitional areas part of production.

This position plays a critical role in the CAR T production processes ensuring appropriate controls, complete traceability, and efficient operations regarding effective cleaning processes of GMP areas and cleanrooms (CNC, Classified Areas), along with EM sampling of these areas.

The AD leads GMP Cleaning/EM Sampling teams and other cleanroom partners across several production areas and multiple shifts (future 12hr/7d Operation). This position assures individual and group compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs and applicable policies, regulations and certifications including training, documentation, standard operating procedures, and corporate policies, while maintaining a culture of safety, compliance, innovation, and Continuous Improvement.

Shifts Available:

Monday – Friday, Standard Working Hours

Responsibilities:

• Accountable for completion of production 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).
• Responsible for role modeling and driving safety, accountability and sustainable processes within the team and respective team members. Perform regular safety Gemba walks, identify the hazards associated with team’s work and provide process-based solutions for safety challenges.
• Accountable for the Production Records/Process Documentation produced by the team. Execute/perform batch record reviews (BRR) or Electronic Batch Record review by exception and ensure that all documentation produced by the team follows the ALCOA+ principles.
• Perform Cell Therapy production 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.     
• Responsible for providing the Production Scheduling team with information (daily, weekly monthly) on the availability production resources and task execution/progression.
• Actively set team priorities and adjust as necessary to align with site and or functional priorities, establishes the team goals and monitor, measure and assess the performance/completion of the team production activities and goals. Report performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans.
• Drive completion, adherence to training requirements and assess appropriate level of training for team members, complete training plan on time and ensure proficiency and qualification to perform the production tasks.  Monitor team training due dates and maintain the trained