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) 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 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.). 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 Summit West (NJ): $27.83 - $33.72 per hour (additional incentive cash/stock may be available based on eligibility). Benefits Health coverage; wellbeing support programs; 401(k) and financial protection benefits; paid time off (details vary by employee category/location). #J-18808-Ljbffr Scorpion Therapeutics