Manufacturing Associate, Liso-cel CAR-T, Manufacturing 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)

• 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 an 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.).

• 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.

• 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.

• 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.

Summit West (NJ): $27.83 - $33.72 per hour (additional incentive cash/stock may be available based on eligibility).

Health coverage; wellbeing support programs; 401(k) and financial protection benefits; paid time off (details vary by employee category/location).