Operations Associate, Sun-Wed, 1st Shift

Legend Biotech • Raritan, NJ

110d • $57,445 - $75,396

About The Position

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.

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 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.

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.

Benefits

• Medical, dental, and vision insurance.
• 401(k)-retirement plan with company match that vest fully on day one.
• Equity and stock options available to employees in eligible roles.
• Eight weeks of paid parental leave after just three months of employment.
• Paid time off policy that includes 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.
• Short- and long-term 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.
• Peer-to-peer recognition programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: High school or GED