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

Scorpion Therapeutics; Summit (NJ); On-site; USD 39,000 - 47,000; Full time

Job summary

Scorpion Therapeutics in Summit, NJ is seeking an Onsite Afternoon Shift Cell Therapy Manufacturing Operator. Shift: Tuesday–Saturday, 1:30 p.m.–10:00 p.m. (times may change).

You will set up and operate equipment to produce blood component lots through cell culture, harvest, and cryopreservation. Responsibilities include supporting deviation investigations, aseptic technique, data recording per GDPs, and adherence to GMP and safety policies.

Qualifications

• Basic understanding of cell culture, cryopreservation, 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.

Responsibilities

• Set up and operate equipment to produce blood component lots through cell culture, harvest, and cryopreservation.
• Support deviation investigations and CAPA closures; assist timely closure of assigned actions.
• Perform aseptic technique for tube activities; maintain aseptic qualification.
• Weigh and measure in-process materials to ensure proper quantities.
• Adhere to the production schedule and internal production logistics; maintain production records.

Skills

Cell culture basics

cGMP/FDA regulated

Math & technical writing

MS Office proficiency

Education

High School Diploma

Bachelor’s/Associate preferred

Job description

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.