Manufacturing Associate, CAR-T

Role Summary

Manufacturing Associate, CAR-T in Cell Therapy. Manufactures human blood derived components per Batch Record and Standard Operating Procedures in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Adheres to regulatory requirements; performs job functions within a team according to a production shift schedule and communicates production deviations and assists with quality investigations as applicable. Shift available: Onsite Night Shift, 9pm – 5:30am (Shift 3, Tuesday–Saturday). 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; assist with on-time closure of assigned CAPAs within the shift.
• Aseptic technique required for tube welding, connections, and transfers at minimum; aseptic qualification is required.
• Weigh and measure in-process materials to ensure proper quantities are added/removed.
• Adhere to production schedule ensuring on-time, internal production logistics.
• Record production data and information clearly and concisely according to GDPs.
• Perform tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
• Work in a team-based, cross-functional environment to complete production tasks per shift schedule.
• Act as a motivated, team-conscious individual to fulfill job requirements; become an SME and qualified trainer within a designated function of manufacturing.
• Supervision by the shift Supervisor or designated Team Lead; maintain on-time completion of training assignments to maintain technical skills and process knowledge.

Qualifications

• 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 Operations experience.
• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills; general understanding of cGMPs; technical writing capability; proficient in MS Office; background in biology, chemistry, medical or clinical practices.

Skills

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Background in biology, chemistry, medical or clinical practices.

Education

• Bachelor's degree with no manufacturing experience; or Associate/Medical Technical degree with manufacturing experience; or High School diploma/GED with manufacturing experience.

Additional Requirements

• Intermittent walking, standing and sitting; ability to stand for extended periods.
• Comfort working with contained human blood components.
• Physical dexterity to use computers and documentation; adequate vision and hearing for the job.
• Ability to lift up to 25 pounds; ability to work in laboratories and restricted areas with cleanroom garments and PPE.
• Reagents, chemicals, and exposure to sanitization agents; routine exposure to human blood components.
• Restricted areas prohibit food and outside materials; PPE compliance required.