Operations Associate

Raritan, NJfull timeOn Site

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entry

$59k–$78k

H1B: no

Legendcareers The Operations Associate at Legend Biotech performs manufacturing procedures within a cGMP environment for autologous CAR-T products. The role involves executing manufacturing tasks, maintaining quality and compliance, and supporting continuous improvement.

Responsibilities

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.
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.

Qualification

Follow instructionsAddKnowledge of Process Excellence ToolsWhile performing the duties of this jobAbility to lift 25 lbs

Required

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.
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.