Shift Available:
- Tuesday–Saturday, Onsite Afternoon Shift, 1:30 p.m. – 10:00 p.m. (start/end times may change)
Responsibilities:
- Set up and operate equipment to produce blood component lots through cell culture, harvest, and cryopreservation.
- Support deviation investigations/write-ups; support on-time closure of assigned CAPAs.
- Perform aseptic technique for tube activities (welding, connections, transfers); maintain aseptic qualification.
- Weigh and measure in-process materials to ensure proper quantities.
- Adhere to the production schedule and internal production logistics.
- Record production data/information clearly and concisely per GDPs.
- Follow safety policies, quality systems, and GMP requirements.
- Work cross-functionally as part of a team per the shift schedule; maintain training and become a SME/trainer within a designated manufacturing function.
- Perform other assigned tasks (continuous improvement, inspection readiness, right-first-time initiatives).
Knowledge & Skills (required/preferred):
- Basic understanding of cell culture, cryopreservation, purification, and aseptic processing/lab technique.
- Knowledge of cGMP/FDA regulated industry; general understanding of cGMPs.
- Basic math; technical writing; proficient MS Office; understanding of biology/chemistry/medical or clinical practices.
Minimum Requirements:
- High School Diploma required; Bachelor’s/associate degree preferred.
- 0–1 years of cGMP cell therapy manufacturing/bioprocessing manufacturing or relevant experience.
Working Conditions:
- Stand for extended periods; work with contained human blood components; lift up to 25 lbs; work in labs/cleanrooms with PPE and restricted-area rules.
Compensation (hourly, Summit West – NJ – US): $27.83–$33.72 per hour.