Cell Culture GMP Manufacturing Technician

VetJobs; New Jersey; On-site; USD 79,901,000 - 96,432,000; Full time

Job summary

Summit West, NJ-based manufacturing role at Bristol Myers Squibb focuses on producing blood component lots through cell culture, harvest, and cryopreservation. The role supports CAPA closures, deviation investigations, and adherence to GDPs and GMP requirements within a cross-functional team.

The position requires understanding of biology/chemistry, cGMP/FDA practices, and strong documentation skills. On-site in Summit West with a shift pattern and training responsibilities outlined.

Qualifications

• 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.
• Pre-requisites: prior experience in Manufacturing and/or scientific/engineering education.
• Associate / Medical Technical degree and 3 years of Manufacturing.
• Operations experience.
• High School diploma/GED and 2 years of Manufacturing or Operations experience.

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.

Skills

Cell culture

Cryopreservation

Purification

Aseptic processing

cGMP/FDA

Technical writing

MS Office

Biology knowledge

Manufacturing experience

Operations experience

Education

Bachelor’s degree

High School/GED

Associate / Medical Technical degree

Job description

Summit West, NJ-based manufacturing role at Bristol Myers Squibb focuses on producing blood component lots through cell culture, harvest, and cryopreservation. The role supports CAPA closures, deviation investigations, and adherence to GDPs and GMP requirements within a cross-functional team.

The position requires understanding of biology/chemistry, cGMP/FDA practices, and strong documentation skills. On-site in Summit West with a shift pattern and training responsibilities outlined.