Operations Associate

Role Overview

Legend Biotech is seeking Operations Associate as part of the Technical Operations team based in Raritan, NJ
.

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.

Shift

Schedule:

Wed-Sat 2nd Shift

• 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 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 any 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: pass.
• Support the ongoing production schedule by: 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; promote teamwork; learn new skills and procedures; continue professional development; support investigation efforts as required; participate in audit preparation and activities.

• HS Diploma required with 3 – 5 years Biotech/Pharmaceutical experience or equivalent industry experience, OR Associates Degree in Life Sciences or Manufacturing with 2-3 years of related experience, OR Bachelor’s Degree in Life Sciences with 0-2 years Biotech/Pharmaceutical experience or equivalent industry experience.
• Ability to interpret a variety of instructions in written, oral, diagram or schedule form; follow instructions; solve practical problems in situations with limited standardization.
• Ability to perform basic mathematical operations in all units of measure; operate manufacturing, manufacturing-support and lab equipment.
• Knowledge of Process Excellence Tools and routine/non-routine testing methods and related equipment.
• Mobility to independently transport between sites/locations as required by essential functions.
• Strong communication skills with coworkers; willingness to work in a team; ability to stand, walk, climb, bend and stoop; reach with hands and arms; lift up to 25 lbs.
• Ability to perform gowning procedures to work in manufacturing core.

The anticipated base pay range is: $57,445 USD - $75,396 USD

We are committed to creating a workplace where employees can thrive. Our benefits package includes medical, dental, and vision insurance; a 401(k) retirement plan with company match; equity and stock options for eligible roles; eight weeks of paid parental leave after three months; paid time off including 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays;

flexible spending and health savings accounts; life and AD&D insurance; disability coverage; legal assistance; supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance; commuter benefits; family planning and care resources; well-being initiatives; and peer-to-peer recognition programs.

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting,…