Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations
Bristol Myers Squibb
2 days ago
On-site
Summit, NJ
Operations
Shift Available:
- Wednesday - Saturday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m. (start/end times subject to change)
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; support on-time closure of assigned CAPAs within the designated shift.
- Use aseptic technique for welding, connections, and transfers (minimum); maintain aseptic qualification.
- Weigh and measure in-process materials to ensure proper quantities are added/removed.
- Adhere to the production schedule to ensure on-time internal production logistics.
- Record production data in a clear, concise format according to GDPs.
- Perform all tasks per site safety policies, quality systems, and GMP requirements.
- Work in a team-based, cross-functional environment to complete shift production tasks.
- Become a SME and qualified trainer within a designated manufacturing function.
- Maintain on-time completion of training assignments.
- Perform other assigned tasks (e.g., continuous improvement, inspection readiness, right-first-time initiatives).
Knowledge & Skills:
- Basic understanding of cell culture, cryopreservation, purification, and aseptic processing/lab technique.
- Knowledge of cGMP/FDA regulated industry and general understanding of cGMPs.
- Basic mathematical skills; technical writing capability.
- Proficient in MS Office.
- Background understanding of biology, chemistry, medical, or clinical practices.
Minimum 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 or Operations experience.
Working Conditions:
- Intermittent walking/standing/sitting; ability to stand for extended periods.
- Comfortable working with contained human blood components; ability to lift 25 pounds.
- Work in laboratories and controlled, enclosed, restricted areas; cleanroom garments and PPE required.
- Must be flexible to don cleanroom garments/PPE; routine exposure to human blood components.
- Restricted areas prohibit food and outside materials (e.g., cell phones, tablets).
Compensation Overview (listed):
- Summit West - NJ - US $27.83 - $33.72 per hour.
- Wednesday - Saturday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m. (start/end times subject to change)
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; support on-time closure of assigned CAPAs within the designated shift.
- Use aseptic technique for welding, connections, and transfers (minimum); maintain aseptic qualification.
- Weigh and measure in-process materials to ensure proper quantities are added/removed.
- Adhere to the production schedule to ensure on-time internal production logistics.
- Record production data in a clear, concise format according to GDPs.
- Perform all tasks per site safety policies, quality systems, and GMP requirements.
- Work in a team-based, cross-functional environment to complete shift production tasks.
- Become a SME and qualified trainer within a designated manufacturing function.
- Maintain on-time completion of training assignments.
- Perform other assigned tasks (e.g., continuous improvement, inspection readiness, right-first-time initiatives).
Knowledge & Skills:
- Basic understanding of cell culture, cryopreservation, purification, and aseptic processing/lab technique.
- Knowledge of cGMP/FDA regulated industry and general understanding of cGMPs.
- Basic mathematical skills; technical writing capability.
- Proficient in MS Office.
- Background understanding of biology, chemistry, medical, or clinical practices.
Minimum 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 or Operations experience.
Working Conditions:
- Intermittent walking/standing/sitting; ability to stand for extended periods.
- Comfortable working with contained human blood components; ability to lift 25 pounds.
- Work in laboratories and controlled, enclosed, restricted areas; cleanroom garments and PPE required.
- Must be flexible to don cleanroom garments/PPE; routine exposure to human blood components.
- Restricted areas prohibit food and outside materials (e.g., cell phones, tablets).
Compensation Overview (listed):
- Summit West - NJ - US $27.83 - $33.72 per hour.