Biotech CGMP Manufacturing Operations Associate

Legend Biotech EU; Raritan (NJ); On-site; USD 59,000 - 78,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Eight weeks of paid parental leave

Job summary

Legend Biotech, based in Bridgewater, NJ, seeks an Operations Associate to join the Manufacturing & Supply team in Raritan. The role performs manufacturing procedures in a CGMP environment and ensures quality and compliance with company policies and regulations.

The candidate will handle autologous CAR-T product operations and contribute to continuous improvement. Qualifications include a HS diploma with biotech experience or an advanced degree, ability to operate manufacturing and lab

Qualifications

• Interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Follow instructions and solve practical problems with limited standardization.
• Understand measurements and conversions; perform basic math.
• Operate manufacturing, manufacturing-support and lab equipment.
• Familiarity with process improvement tools.

Responsibilities

• Be part of the manufacturing operations team producing autologous CAR-T products in a cGMP cleanroom.
• Independently execute manufacturing or support processes per SOPs and batch records.
• Perform cell culture, purification, aseptic processing, and cryopreservation activities.
• Record production data clearly and in GDP-compliant format.
• Complete tasks on schedule and support shift production goals.
• Maintain a safe, clean work environment and comply with PPE and safety procedures.
• Collaborate in cross-functional teams to drive process improvements.

Skills

Biotech/pharma experience

cGMP knowledge

GDP documentation

Problem solving

Communication

Mobility between sites

Education

HS Diploma or equivalent

Associates degree in Life Sciences or Manufacturing

Bachelor's in Life Sciences

Tools

Manufacturing equipment

Lab equipment

Process Excellence Tools

Job description

Legend Biotech, based in Bridgewater, NJ, seeks an Operations Associate to join the Manufacturing & Supply team in Raritan. The role performs manufacturing procedures in a CGMP environment and ensures quality and compliance with company policies and regulations.

The candidate will handle autologous CAR-T product operations and contribute to continuous improvement. Qualifications include a HS diploma with biotech experience or an advanced degree, ability to operate manufacturing and lab