Operations Associate, 1st Shift

Legend Biotech Corp•Raritan, NJ

56d•Onsite

About The Position

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 a diverse array of technology platforms, including 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 apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Operations Associate 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. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Schedule: Sun-Wed, 1st Shift

Requirements

HS Diploma required with 3 - 5 Years Biotech/Pharmaceutical experience or equivalent industry experience // OR // Associates Degree required in Life Sciences or Manufacturing with 2 - 3 years of related experience // OR //Bachelors 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 factions, and decimals.
Knowledge and ability to operate manufacturing, manufacturing-support and lab equipment.
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.
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
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals

Nice To Haves

Knowledge of Process Excellence Tools

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 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 SOP's, 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.
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.

Benefits

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

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