Lead Associate, Clinical Cell Therapy Manufacturing in Devens, MA

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.

BMS Cell Therapy Manufacturing is seeking a Lead Associate, Clinical Cell Therapy Manufacturing that bring enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. We are searching for enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support start up activities, and routine manufacturing operations for Cell Therapy. This role is key to start up of Clinical Trials at Devens in a multi-product Cell Therapy Facility.

Shifts Available:

M-F, standard working hours (there will need to be flexibility and this could be subject to change in the future)

Responsibilities:

• Execute operations described in standard operating procedures and batch records.
• Demonstrates strong practical and theoretical knowledge in their work
• Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Solves complex problems; takes new perspectives using existing solutions
• Performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
• Completing training assignments to ensure the necessary technical skills and knowledge.
• Sets up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
• Collaborates with support groups on recommendations and solving technical problems.
• Help to ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule.
• Collaborates closely with Shift Managers to ensure seamless pass down and communication of operational status.
• Supports investigations 
• Identifies innovative solutions
• Supports writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Training others on SOPs, Work Instructions to successfully complete manufacturing operations.
• Working with production planning with leadership to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.

Knowledge and Skills:

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).
• Must be able to work in a cleanroom environment and perform aseptic processing
• Must be comfortable being exposed to hum