Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations
Bristol Myers Squibb
6 months ago
On-site
Summit, NJ
Operations
Shift Available:
- Quad 2 Sunday - Wednesday (with e/o Wednesday off), Onsite Overnight Shift, 5 p.m. - 5:30 a.m. (start/end times may change based on business demands)
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 assigned CAPAs within the designated shift.
- Perform aseptic technique for tube-most activities 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 clearly and concisely according to proper GDPs.
- Perform all tasks consistent with site safety policies, quality systems, and GMP requirements.
- Work in a team-based, cross-functional environment to complete production tasks required by the shift schedule.
- Become a SME and qualified trainer within a designated function of manufacturing (supervised by shift Supervisor or Team Lead).
- 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.).
Knowledge & Skills:
- Basic understanding of cell culture, cryopreservation, purification, and aseptic processing/lab technique.
- Knowledge of cGMP/FDA regulated industry; general understanding of cGMPs.
- Basic mathematical skills.
- Technical writing capability; proficient in MS Office.
- Background understanding of biology, chemistry, medical or clinical practices.
Basic Requirements:
- Bachelor’s degree with no prior Manufacturing Operations experience; OR
- Associate/Medical Technical degree with 2 years of Manufacturing Operations experience; OR
- High School diploma/GED with 4 years of Manufacturing or Operations experience.
Working Conditions:
- Intermittent walking/standing/sitting; ability to stand for extended periods may be necessary.
- Comfortable working with contained human blood components.
- Physical dexterity to use computers and documentation; sufficient vision/hearing.
- Ability to lift 25 pounds.
- Ability to work in laboratories and controlled, enclosed, restricted areas.
- Cleanroom garments and PPE required in designated areas; no makeup/gum/nail polish/perfume/cologne or other potential microbial sources in restricted areas.
- Cleanroom is enclosed/restricted with assigned pressure and temperature conditions; exposure to reagents/chemicals/sanitization agents; routine exposure to human blood components.
Compensation (if applicable):
- Summit West (NJ): $27.83 - $33.72 per hour (additional incentive cash/stock may be available based on eligibility).
Benefits (explicitly listed):
- Health coverage; wellbeing support programs; 401(k) and financial protection benefits; paid time off (details vary by employee category/location).
- Quad 2 Sunday - Wednesday (with e/o Wednesday off), Onsite Overnight Shift, 5 p.m. - 5:30 a.m. (start/end times may change based on business demands)
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 assigned CAPAs within the designated shift.
- Perform aseptic technique for tube-most activities 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 clearly and concisely according to proper GDPs.
- Perform all tasks consistent with site safety policies, quality systems, and GMP requirements.
- Work in a team-based, cross-functional environment to complete production tasks required by the shift schedule.
- Become a SME and qualified trainer within a designated function of manufacturing (supervised by shift Supervisor or Team Lead).
- 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.).
Knowledge & Skills:
- Basic understanding of cell culture, cryopreservation, purification, and aseptic processing/lab technique.
- Knowledge of cGMP/FDA regulated industry; general understanding of cGMPs.
- Basic mathematical skills.
- Technical writing capability; proficient in MS Office.
- Background understanding of biology, chemistry, medical or clinical practices.
Basic Requirements:
- Bachelor’s degree with no prior Manufacturing Operations experience; OR
- Associate/Medical Technical degree with 2 years of Manufacturing Operations experience; OR
- High School diploma/GED with 4 years of Manufacturing or Operations experience.
Working Conditions:
- Intermittent walking/standing/sitting; ability to stand for extended periods may be necessary.
- Comfortable working with contained human blood components.
- Physical dexterity to use computers and documentation; sufficient vision/hearing.
- Ability to lift 25 pounds.
- Ability to work in laboratories and controlled, enclosed, restricted areas.
- Cleanroom garments and PPE required in designated areas; no makeup/gum/nail polish/perfume/cologne or other potential microbial sources in restricted areas.
- Cleanroom is enclosed/restricted with assigned pressure and temperature conditions; exposure to reagents/chemicals/sanitization agents; routine exposure to human blood components.
Compensation (if applicable):
- Summit West (NJ): $27.83 - $33.72 per hour (additional incentive cash/stock may be available based on eligibility).
Benefits (explicitly listed):
- Health coverage; wellbeing support programs; 401(k) and financial protection benefits; paid time off (details vary by employee category/location).