Specialist, Lead Manufacturing Associate 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.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

Serve as a Specialist, Lead Manufacturing Associate Cell Therapy in the manufacture of human blood derived components per Batch Records and Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment. Lead Manufacturing Associate adheres to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Support the quad manager for communication of production deviations, review of executed batch records and assistance with quality investigations are required, as applicable. The Lead Manufacturing Associate works closely with the Quad Manager and serves to supervise the shift when the manager is not available.  The Lead Manufacturing Associate is also a qualified trainer for all buckets of operation.

Shifts Available:

All positions currently available are with Breyanzi:

• Harvest: Quad 1, Quad 2, & Quad 4
• Selection: 3rd Shift
• Media: Quad 1 (6am - 6:30pm)

Hours:

• Q1: 5am – 530pm Sunday – Tues and every other Wed.
• Q2: 5pm – 530am Sunday – Tues and every other Wed.
• Q3: 5am – 530pm Thursday – Sat and every other Wed.
• Q4: 5pm – 530am Thur – Sat and every other Wed.

• 1st Shift: Tuesday – Saturday 6:00am - 2:30pm
• 2nd Shift: Tuesday – Saturday 1:30pm - 10:00pm
• 3rd Shift: Tuesday – Saturday 9:00pm - 5:30am

Responsibilities:

• Production of blood component lots for one CAR-T bucket of operations
• Cross trained in all other buckets of operations (based on availability and business need)
• Provide training and guidance to manufacturing associates as required.
• Aseptic technique is required for most activities: tube welding, connections, and transfers, at minimum.
• Aseptic qualification required per bucket
• Weigh and measure in-process materials to ensure proper quantities are added/removed.
• Perform and oversee process unit operations described in standard operating procedures and batch records.
• Complete and review documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Assist Manager to ensure the shift performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
• Serve as a qualified trainer to maintain the shift at an acceptable qualification standard.
• Support deviation investigations and on-time closure of deviations and CAPAs.
• Work with Manager to schedule daily unit operations that includes people, product, and material flow across multiple shifts.
• Ensure associates execute scheduled activities on-time, in accordance with the production schedule.
• Ensure the batch records for production data and all information are in a clear, concise, format according to proper GDPs.
• 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 Managers to ensure seamless pass down and communication of operational status.
• Other duties may be assigned, as necessary.
• No direct reports will be assigned to this job role.

Knowledge & Skills:

• Thorough understanding of media production (if a