CAR-T Cell Therapy Manufacturing Specialist

Legend Biotech US; Raritan (NJ); Presencial; USD 59 000 - 78 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Parental leave

Paid time off

Flexible spending accounts

Health savings account

Life insurance

AD&D insurance

Disability insurance

Commuter benefits

Well-being programs

Resumo da oferta

Legend Biotech US, based in Raritan, NJ, is seeking an Operations Associate to join the Manufacturing & Supply team. You will perform manufacturing procedures in a CGMP environment, ensuring quality and regulatory compliance while supporting scheduled tasks.

You will execute processes across cell culturing, purification, aseptic processing, and cryopreservation, document data per GDP, and collaborate with a cross-functional team to meet production goals and maintain a safe, cleanroom operation.

Qualificações

• HS Diploma (3–5 years biotech/pharma exp) or Associate degree (2–3 yrs Life Sciences/Manufacturing).
• Bachelor's in Life Sciences with 0–2 years biotech/pharma exp.
• Ability to interpret various instructions and follow procedures.
• Problem solving with concrete variables and limited standardization.
• Ability to perform basic math in all units of measure.
• Knowledge of manufacturing, lab equipment and related processes.
• Must be mobile to travel between sites as needed.
• Excellent communication with coworkers and team collaboration.
• Able to stand, walk, climb, bend, stoop, reach; lift 25 lbs.
• Gowning procedures for cleanroom manufacturing.

Responsabilidades

• Participate in production of autologous CAR‑T products in CGMP cleanroom.
• Execute manufacturing and support processes per SOPs and curriculum.
• Perform cell culturing, purification, aseptic processing, and cryopreservation.
• Record production data accurately under GDP.
• Maintain quality systems and comply with cGMP.
• Work in cross-functional team to meet shift schedule.
• Assist process development with proper documentation.
• Support production schedule adjustments and investigations.
• Prepare for audits and participate as required.

Conhecimentos

Instructions interpretation

Follow instructions

Problem solving

Math skills

Equipment operation

Communication

Teamwork

Mobility between sites

Lifting ability

Gowning procedures

Formação académica

HS Diploma or equivalent

Associate's Degree Life Sciences/Manufacturing

Bachelor's Degree Life Sciences

Ferramentas

Process Excellence Tools

Manufacturing equipment

Lab equipment

Descrição da oferta de emprego

Legend Biotech US, based in Raritan, NJ, is seeking an Operations Associate to join the Manufacturing & Supply team. You will perform manufacturing procedures in a CGMP environment, ensuring quality and regulatory compliance while supporting scheduled tasks.

You will execute processes across cell culturing, purification, aseptic processing, and cryopreservation, document data per GDP, and collaborate with a cross-functional team to meet production goals and maintain a safe, cleanroom operation.