Cell Therapy Manufacturing Operator (CGMP)

Legend Biotech, Inc.; United States; On-site; USD 59,000 - 78,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave and holidays

Job summary

Legend Biotech, Inc. is seeking an Operations Associate for the Manufacturing & Supply team in Raritan, NJ. The role focuses on executing manufacturing procedures for autologous CAR-T products in a CGMP environment, ensuring quality and regulatory compliance.

You will work in a cross-functional team, perform documentation per GDP, and support process improvements while maintaining a safe, clean manufacturing area and adhering to PPE protocols.

Qualifications

• HS Diploma required with 3–5 years Biotech/Pharmaceutical experience or equivalent industry experience.
• Associates Degree required in Life Sciences or Manufacturing with 2–3 years of related experience.
• Bachelor's Degree required in Life Sciences with 0–2 years Biotech/Pharmaceutical experience or equivalent industry experience.

Responsibilities

• Be part of the manufacturing operations team responsible for production of autologous CAR-T products in a CGMP cleanroom.
• Independently execute manufacturing or manufacturing-support processes according to SOPs and batch records.
• Perform operations in cell culturing, purification, aseptic processing and cryopreservation.
• Record production data clearly and concisely per GDP.
• Support schedule adjustments to meet production needs.
• Maintain a safe, clean work environment and comply with PPE requirements.

Skills

Interpret instructions

Problem solving

GDP knowledge

cGMP knowledge

Education

HS Diploma

Associates Degree

Bachelor's Degree

Job description

Legend Biotech, Inc. is seeking an Operations Associate for the Manufacturing & Supply team in Raritan, NJ. The role focuses on executing manufacturing procedures for autologous CAR-T products in a CGMP environment, ensuring quality and regulatory compliance.

You will work in a cross-functional team, perform documentation per GDP, and support process improvements while maintaining a safe, clean manufacturing area and adhering to PPE protocols.