Manufacturing Associate, Liso-cel CAR-T, Manufacturing 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. 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.

Position Summary

Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.

Shift schedules are as follows:

• Day Shift (Quad 1 or Quad 3): 5:00 AM – 5:30 PM, Sunday–Wednesday or Wednesday–Saturday
• Night Shift (Quad 2 or Quad 4): 5:00 PM – 5:30 AM, Sunday–Wednesday or Wednesday–Saturday

Start and end times are subject to change based on business demands.

Duties & Responsibilities

• Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
• Support deviation investigations and write-ups as needed; support on-time closure of any assigned CAPAs within the designated shift.
• Apply aseptic technique for tube welding, connections, and transfers, at minimum. Aseptic qualification is required.
• Weigh and measure in-process materials to ensure proper quantities are added/removed.
• Adhere to the production schedule ensuring on-time, internal production logistics.
• Record production data and information in a clear, concise format according to proper GDPs.
• Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
• Work in a team-based, cross-functional environment to complete production tasks required by shift schedule.
• Become a Subject Matter Expert (SME) and qualified trainer within a designated function of manufacturing.
• Maintain on-time completion of training assignments to sustain necessary technical skills and process knowledge.
• Perform other tasks as assigned, including continuous improvement projects, inspection readiness, and right-first-time initiatives.

Reporting Relationship: This position reports to the Manufacturing Manager.

Qualifications

Knowledge, Skills & Abilities:

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
• Knowledge of cGMP/FDA regulated industry
• Basic mathematical skills and general understanding of cGMPs
• Technical writing capability
• Proficient in MS Office applications
• Background in biology, chemistry, or medical/clinical practices
• Prior experience in manufacturing and/or scientific/engineering education preferred

Education (one of the following):

• Bachelor's degree
• Associate's or Medical Technical degree and 3 years of Manufacturing Operations experience
• High School diploma/GED and 2 years of Manufacturing or Operations experience

Working Conditions

• Intermittent walking and sitting to perform job functions; ability to sit or stand for extended periods may be necessary.
• Must be comfortable working with contained human blood components.
• Physical dexterity sufficient to use computers and documentation.
• Sufficient vision and hearing capability to work in job environment.
• Ability to lift up to 25 pounds.
• Must be able to work in laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and personal protective equipment (PPE) are required in designated areas, covering the head, parts of the face, core b