CAR-T Cell Therapy Manufacturing Associate

Biopharma Careers; Summit West (CA); On-site; USD 39,000 - 47,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Paid holidays

Job summary

Bristol Myers Squibb in Summit West, NJ, is seeking a Manufacturing Associate for our CAR-T cell therapy team. The role performs setup and operation of equipment to produce blood component lots through cell culture, harvest, and cryopreservation in a controlled, cGMP cleanroom under supervision.

The shift is Quad 4: Wednesday–Saturday, onsite overnight from 5 p.m. to 5:30 a.m., with times subject to change based on business demands.

Qualifications

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing.
• 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.

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.
• Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc

Skills

Cell culture basics

Cryopreservation

Aseptic processing

cGMP/FDA knowledge

Technical writing

MS Office

Biology/chemistry background

Education

High school diploma or equivalent

Associate or Bachelor's degree in related field preferred

Tools

MS Office

Lab equipment handling

Job description

Bristol Myers Squibb in Summit West, NJ, is seeking a Manufacturing Associate for our CAR-T cell therapy team. The role performs setup and operation of equipment to produce blood component lots through cell culture, harvest, and cryopreservation in a controlled, cGMP cleanroom under supervision.

The shift is Quad 4: Wednesday–Saturday, onsite overnight from 5 p.m. to 5:30 a.m., with times subject to change based on business demands.