Aseptic Manufacturing Associate, Liso-cel CAR-T, Aseptic Manufacturing Operations

Job Overview

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.

Q1:
Sunday - Wednesday (with e/o Wednesday off), Onsite Day Shift, 5 a.m.

- 5:30 p.m.
Q3:
Wednesday - Saturday (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.

• 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.
• Use aseptic technique for tube activities: welding, connections, and transfers.
• Maintain aseptic qualification.
• 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 an SME and qualified trainer within a designated function of manufacturing.
• Maintain on‑time completion of training assignments to maintain technical skills and process knowledge.
• Perform other tasks as assigned: continuous improvement projects, inspection readiness, right‑first‑time initiatives, etc.

• 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 in biology, chemistry, medical or clinical practices.

• High School Diploma required.
• Bachelor's or associate degree preferred.
• 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.

Intermittent walking, standing and sitting to perform job functions; however, ability to 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 25 pounds. Must work in laboratories and controlled, enclosed, restricted areas. Cleanroom garments and personal protective equipment will be required in designated areas.

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.

• Health Coverage:
  Medical, pharmacy, dental, and vision care.
• Well‑being Support:
  Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work‑life benefits include paid time off, flexible time off, 11 national holidays, optional holidays, unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual global shutdown between Christmas and New Years Day.
• Compensation: $27.83 - $33.72 per hour (Summit West – NJ – US). Additional incentive cash and stock opportunities may be available.

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