Manufacturing Associate, Cell Therapy

Manufacturing Associate, Cell Therapy Team

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.

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.

Our Manufacturing Associate, Cell Therapy team manufactures human blood derived components per batch record and standard operating procedures 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 Available:

1. Quad 1: Sunday - Wednesday (with e/o Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 p.m.

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

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.
• Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum.
• Aseptic qualification is required.
• Weighs and measures in-process materials to ensure proper quantities are added/removed.
• Adheres to the production schedule ensuring on-time, internal production logistics.
• Records 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.
• Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
• Motivated, team consciousness individuals are needed to fulfill job requirements.
• Become a SME and qualified trainer within a designated function of manufacturing.
• Supervision will be managed by the shift supervisor or designated team lead.
• Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.

Knowledge & Skills:

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Background to include an understanding of biology, chemistry, medical or clinical practices.

Basic Requirements:

• Bachelor's degree and no prior Manufacturing Operations experience.
• Or Associate/Medical Technical degree and 2 years of Manufacturing Operations experience.
• Or High School diploma/GED and 4 years of Manufacturing Operations experience.

Working Conditions:

• Intermittent walking, standing and sitting to perform job functions; however, ability to stand for extended periods of time 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 25 pounds.
• Must have the ability to work in laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Makeup, gum, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas.
• Flexibility to don clean room garments and personal protective equipment (PPE).
• Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
• Reagents, chemicals, and exposure to sanitization agents are expected.
• Routine exposure to human blood components.
• Restricted areas prohibit food, any outside materials such as cell phones, tablets, at a minimum.