2nd-Shift Biotech Operations Associate

Merck & Co.; Raritan (NJ); On-site; USD 55,000 - 70,000; Full time

Job summary

Legend Biotech, based in Somerset, NJ with an operations footprint in Raritan, NJ, seeks an Operations Associate (2nd Shift) for the Technical Operations team to perform CGMP manufacturing procedures. The role emphasizes quality, compliance, and teamwork in a controlled environment.

The position involves executing cell culture, purification, aseptic processing, and documentation while supporting continuous improvement and safe handling of materials. At times, travel between sites may be required.

Qualifications

• HS Diploma with 3–5 years biotech/pharmaceutical experience or an Associate's Degree with 2–3 years related experience; or a Bachelor's with 0–2 years.
• Ability to interpret various instructions and follow procedures.
• Ability to solve practical problems with limited standardization.
• Proficiency in arithmetic and measurement; operate manufacturing and lab equipment.
• Knowledge of Process Excellence Tools and testing methods.
• Mobility to travel between sites as required.
• Strong communication and teamwork skills.

Responsibilities

• Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a CGMP cleanroom.
• Independently execute manufacturing or manufacturing-support processes per SOPs and batch records.
• Perform cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
• Record production data clearly in GDP-compliant formats.
• Complete tasks on time in line with quality systems and cGMP.
• Collaborate in a cross-functional team to meet shift schedule requirements.
• Aid in development of manufacturing processes and documentation.
• Drive continuous improvement using observations and team input.
• Handle human-derived materials in containment areas.
• Support schedule adjustments to meet production needs.
• Maintain documentation in SOPs and logbooks.
• Demonstrate training progression and basic cGMP knowledge.
• Wear PPE and maintain a clean, safe work environment; report hazards.
• Ensure materials are available for production.
• Participate in audits and investigations as required.

Skills

Biotech manufacturing

cGMP knowledge

Team communication

Education

HS Diploma with 3-5 years biotech/pharma

Associate's Degree

Bachelor's Degree

Tools

Process Excellence Tools

Lab equipment operation

Job description

Legend Biotech, based in Somerset, NJ with an operations footprint in Raritan, NJ, seeks an Operations Associate (2nd Shift) for the Technical Operations team to perform CGMP manufacturing procedures. The role emphasizes quality, compliance, and teamwork in a controlled environment.

The position involves executing cell culture, purification, aseptic processing, and documentation while supporting continuous improvement and safe handling of materials. At times, travel between sites may be required.