Operations Associate

Legend Biotech USA; Raritan (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

Legend Biotech USA is seeking an Operations Associate (2nd Shift) to join the Technical Operations team in Raritan, NJ. The role executes manufacturing procedures in a CGMP environment and maintains quality and compliance with company policies and regulations.

The position requires hands-on experience in biotech manufacturing, the ability to follow SOPs, record data accurately, and work cross-functionally to meet production goals and continuous improvement initiatives.

Qualifications

• Biotech/pharmaceutical manufacturing experience or related industry exposure.
• Solid understanding of GMP/cGMP
• Experience in GDP/documentation practices and record-keeping.
• Ability to interpret instructions and solve practical problems in a manufacturing setting.

Responsibilities

• Perform manufacturing and manufacturing-support processes per SOPs.
• Record production data in GDP-compliant formats.
• Work in a CGMP cleanroom and assist process development efforts.
• Support production scheduling and cross-functional collaboration.

Skills

Biotech manufacturing experience

GMP knowledge

Documentation skills

Problem solving

Education

HS Diploma

Associate’s Degree Life Sciences

Bachelor’s Degree Life Sciences

Job description

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 also responsible for quality and maintaining the highest standards in compliance with company policies, procedures, and all applicable regulations.

Key Responsibilities

• Be part of the manufacturing operations team responsible for production of autologous CAR‑T products for clinical and commercial operation in a controlled 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 observation 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 working environments.
• Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
• Ensure materials are available for production.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.
• Color perception both eyes 5 slides out of 8.
• Report to work on‑time and according to the shift schedule.
• Perform other duties as assigned.
• Attend departmental and other scheduled meetings.
• Practice good interpersonal and communication skills.
• Demonstrate positive team‑oriented approach in the daily execution of procedures.
• Promote and work within a team environment.
• Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
• Support investigation efforts as required.
• Responsible for audit preparation and participation.

Requirements

• HS Diploma required with 3–5 years biotech/pharmaceutical experience or equivalent industry experience OR Associate’s Degree required in Life Sciences or Manufacturing with 2–3 years related experience OR Bachelor’s Degree required in Life Sciences with 0–2 years biotech/pharmaceutical experience or equivalent industry experience.
• Interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Follow instructions.
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Knowledge and ability to operate manufacturing, manufacturing‑support and lab equipment.
• Knowledge of Process Excellence Tools.
• Possesses solid knowledge of routine and non‑routine testing and sampling methods, techniques and related equipment.
• Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
• Is frequently required to communicate with coworkers.
• While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms.
• Ability to lift 25 lbs.
• Needs to perform gowning procedures to work in manufacturing core.

Benefits

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

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived 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 at‑Will

Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company.

Privacy Notice

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