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

Overview

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we pursue safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration with Janssen to jointly develop and commercialize cilta-cel, an immunotherapy for multiple myeloma. Legend Biotech is seeking an Operations Associate (2nd Shift) as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. It is responsible for quality and maintaining the highest standards in compliance with company policies, procedures, and all applicable regulations.

Responsibilities

• Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
• Independently execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
• Execute manufacturing activities common to cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
• Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, concise format according to Good Documentation Practices (GDP).
• Perform tasks on time in a manner consistent with quality systems and cGMP requirements.
• Work in a team based, cross-functional environment to complete production tasks required by shift schedule.
• Aid in the development of manufacturing processes including appropriate documentation.
• Drive continuous improvement of manufacturing operations leveraging own observations as well as input of team members.
• Handle human derived materials in containment areas.
• Support schedule adjustments to meet production.
• Accurately complete documentation in SOPs, logbooks and other GMP documents.
• Demonstrate training progression through assigned curriculum.
• Accountable for maintaining a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.
• Wear the appropriate PPE when working in manufacturing and other hazardous environments.
• Proactively maintain a clean and safe work environment and communicate observed safety hazards.
• Ensure materials are available for production.
• Job duties involve exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity requirements and color perception as described in job qualifications (no specific medical disclaimer beyond role requirements).
• Report to work on-time and according to the shift schedule.
• Perform other duties as assigned and attend departmental and scheduled meetings.
• Practice good interpersonal and communication skills; demonstrate a positive team-oriented approach and collaborate effectively.
• Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
• Support investigation efforts as required; participate in audits as needed.

Qualifications

• HS Diploma required with 3–5 years biotech/pharmaceutical experience or equivalent; or an Associate's Degree with 2–3 years related experience; or a Bachelor's Degree with 0–2 years related experience.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to follow instructions and solve practical problems with limited standardization.
• Proficiency in basic arithmetic and measurement units; knowledge and ability to operate manufacturing, manufacturing-support and lab equipment.
• Knowledge of Process Excellence Tools and routine/non-routine testing and sampling methods.
• Mobility to travel between sites as required by essential duties.
• Strong communication skills; ability to work in a team environment.
• Physical requirements: regularly stand, walk, climb, bend and stoop; ability to lift up to 25 lbs; gowning procedures to work in manufacturing core.

Compensation and Benefits

The base pay range is an estimate and may vary based on experience, skills, qualifications, and location. Other types of pay include performance-based bonus and/or equity. Benefits include medical, dental, and vision insurance, a 401(k) with company match, paid parental leave, and a comprehensive PTO/holiday plan. Additional voluntary benefits are available.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

Legend Biotech provides equal employment opportunities without regard to race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice. For information related to our privacy notice, please review Legend Biotech Privacy Notice.