Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations
Bristol Myers Squibb
6 months 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 may change based on business demands)
Responsibilities:
- Set up and operate equipment to produce blood component lots through cell culture, harvest, and cryopreservation.
- Support deviation investigations and write-ups; support on-time closure of assigned CAPAs within the shift.
- Use aseptic technique for tube most activities (welding, connections, transfers); complete aseptic qualification.
- Weigh and measure in-process materials to ensure correct quantities.
- Adhere to the production schedule and maintain on-time internal production logistics.
- Record production data/information clearly and concisely 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-required production tasks.
- Become an SME and qualified trainer in a designated manufacturing function.
- Complete assigned training on time to maintain technical skills and process knowledge.
- 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 math skills.
- Technical writing capability.
- Proficient in MS Office.
- Background understanding of biology, chemistry, and medical/clinical practices.
Minimum Requirements:
- Bachelor’s degree with no prior Manufacturing Operations experience; OR
- Associate/Medical Technical degree plus 2 years of Manufacturing Operations experience; OR
- High school diploma/GED plus 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.
- Physical dexterity for computers and documentation; sufficient vision/hearing.
- Ability to lift 25 pounds.
- Work in laboratories and controlled, enclosed, restricted areas.
- Cleanroom garments/PPE required; restricted-area rules prohibit microbial sources (e.g., makeup, gum, nail polish, perfume/cologne) and outside items such as cell phones/tablets (at minimum).
Compensation Overview:
- Summit West - NJ: $27.83 - $33.72 per hour (additional incentive cash/stock may be available based on eligibility).
- Wednesday - Saturday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m. (start/end times may change based on business demands)
Responsibilities:
- Set up and operate equipment to produce blood component lots through cell culture, harvest, and cryopreservation.
- Support deviation investigations and write-ups; support on-time closure of assigned CAPAs within the shift.
- Use aseptic technique for tube most activities (welding, connections, transfers); complete aseptic qualification.
- Weigh and measure in-process materials to ensure correct quantities.
- Adhere to the production schedule and maintain on-time internal production logistics.
- Record production data/information clearly and concisely 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-required production tasks.
- Become an SME and qualified trainer in a designated manufacturing function.
- Complete assigned training on time to maintain technical skills and process knowledge.
- 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 math skills.
- Technical writing capability.
- Proficient in MS Office.
- Background understanding of biology, chemistry, and medical/clinical practices.
Minimum Requirements:
- Bachelor’s degree with no prior Manufacturing Operations experience; OR
- Associate/Medical Technical degree plus 2 years of Manufacturing Operations experience; OR
- High school diploma/GED plus 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.
- Physical dexterity for computers and documentation; sufficient vision/hearing.
- Ability to lift 25 pounds.
- Work in laboratories and controlled, enclosed, restricted areas.
- Cleanroom garments/PPE required; restricted-area rules prohibit microbial sources (e.g., makeup, gum, nail polish, perfume/cologne) and outside items such as cell phones/tablets (at minimum).
Compensation Overview:
- Summit West - NJ: $27.83 - $33.72 per hour (additional incentive cash/stock may be available based on eligibility).