Operations Associate

Legend Biotech US • Raritan, NJ

2d • $59,168 - $77,658 • Onsite

About The Position

Legend Biotech is seeking an Operations Associate for its Manufacturing & Supply team in Raritan, New Jersey. The role performs manufacturing procedures and scheduled tasks in a current Good Manufacturing Practice (cGMP) environment, with responsibility for product quality and compliance with company policies, procedures, and applicable regulations. The associate supports production of autologous CAR-T products for clinical and commercial operations in a controlled cleanroom environment.

The position independently executes manufacturing and manufacturing-support processes, including cell culturing, purification, aseptic processing, and cryopreservation. It requires accurate production documentation, adherence to standard operating procedures and batch records, teamwork across functions, and participation in continuous improvement, process development, investigations, and audit preparation. The role involves handling biological materials and hazardous chemicals, working according to a shift schedule, wearing appropriate PPE, gowning for manufacturing areas, and maintaining a clean and safe work environment.

Requirements

• High school diploma and 3–5 years of biotechnology or pharmaceutical experience, or equivalent industry experience; OR an associate degree in Life Sciences or Manufacturing and 2–3 years of related experience; OR a bachelor's degree in Life Sciences and 0–2 years of biotechnology or pharmaceutical experience, or equivalent industry experience.
• Ability to interpret written, oral, diagrammatic, and schedule-based instructions and follow instructions.
• Ability to solve practical problems and handle concrete variables in situations with limited standardization.
• Ability to add, subtract, multiply, and divide using whole numbers, common fractions, and decimals.
• Knowledge of and ability to operate manufacturing, manufacturing-support, and laboratory equipment.
• Knowledge of Process Excellence Tools.
• Solid knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment.
• Ability to work the production shift schedule and communicate frequently with coworkers.
• Ability to travel independently between various sites or locations as required by the job.
• Ability to stand, walk, climb, bend, stoop, and reach with hands and arms as required by the job.
• Ability to lift 25 pounds.
• Ability to perform gowning procedures to work in the manufacturing core.
• Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses, or corrected to 20/40 or better with corrective lenses.
• Color perception: identify 5 of 8 slides in both eyes.
• Authorization to work in the United States; employment eligibility is verified through Form I-9 and E-Verify.

Responsibilities

• Perform manufacturing and manufacturing-support processes according to standard operating procedures, assigned training curriculum, and batch records.
• Support production of autologous CAR-T products for clinical and commercial operations in a controlled cGMP cleanroom environment.
• Execute cell culturing, purification, aseptic processing, cryopreservation, and other manufacturing unit operations using appropriate techniques.
• Record production data and complete SOPs, batch records, logbooks, and other GMP documents accurately and in accordance with Good Documentation Practices.
• Complete assigned tasks on time and in compliance with quality systems and cGMP requirements.
• Work with cross-functional team members to complete production tasks required by the shift schedule and support schedule adjustments as needed.
• Assist with development of manufacturing processes and associated documentation.
• Drive continuous improvement using personal observations and input from team members.
• Handle human-derived materials in containment areas and routinely work with biological materials and hazardous chemicals.
• Ensure materials are available for production.
• Maintain knowledge of basic cGMP requirements and adhere to applicable compliance policies and regulations.
• Wear appropriate PPE, follow gowning procedures, and proactively maintain a clean and safe work environment; address safety hazards and communicate unsafe behaviors.
• Demonstrate progress through assigned training curriculum and continue developing professionally by learning new skills, procedures, and processes.
• Report to work on time according to the shift schedule, attend scheduled departmental and other meetings, and perform other duties as assigned.
• Practice effective interpersonal and communication skills and promote a positive, team-oriented work environment.
• Support investigations as required.
• Prepare for and participate in audits.

Benefits

• Performance-based bonus and/or equity for employees in eligible roles.
• Medical insurance.
• Dental insurance.
• Vision insurance.
• 401(k) retirement plan with company match that vests fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid time off including vacation, personal time, sick time, floating holidays, and eleven company holidays.
• Flexible spending accounts and health savings accounts.
• Life and AD&D insurance.
• Short- and long-term disability coverage.
• Legal assistance.
• Supplemental pet, critical illness, accident, and hospital indemnity insurance plans.
• Voluntary commuter benefits.
• Family planning and care resources.
• Well-being initiatives.
• Peer-to-peer recognition programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level