BioSpace
Operations Associate (Raritan, NJ)
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.
Role Overview This position is responsible for performing manufacturing procedures and executing scheduled tasks within a CGMP environment. The role focuses on quality, compliance, and maintaining the highest standards in accordance with company policies and all applicable regulations. Shift schedule: Wed‑Sat 1st Shift.
Key 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 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 appropriate PPE when working in manufacturing and other hazardous environments.
Proactively maintain a clean and safe work environment and eliminate safety hazards.
Ensure materials are available for production and support the ongoing production schedule.
Job duties require exposure to and handling of biological materials and hazardous chemicals.
Visual acuity of at least 20/40 (Snellen) without corrective lenses or corrected to 20/40 with lenses.
Color perception 5 slides out of 8.
Support the ongoing production schedule by reporting to work on‑time, performing other duties as assigned, attending meetings, practicing good interpersonal skills, promoting teamwork, learning new skills, supporting investigations, and preparing for audits.
Requirements
HS Diploma required with 3–5 years biotech/pharmaceutical experience or equivalent industry experience; OR Associate’s Degree in Life Sciences or Manufacturing with 2–3 years experience; OR Bachelor’s Degree in Life Sciences with 0–2 years experience.
Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Follow instructions and solve practical problems with limited standardization.
Perform basic arithmetic in all units of measure.
Knowledge and ability to operate manufacturing, manufacturing‑support, and lab equipment.
Knowledge of process excellence tools.
Solid knowledge of routine and non‑routine testing and sampling methods and related equipment.
Be mobile and able to transport between sites as required.
Communicate frequently with coworkers.
Ability to stand, walk, climb, bend, stoop, and reach with hands and arms.
Ability to lift 25 lbs.
Perform gowning procedures to work in manufacturing core.
Compensation Anticipated base pay range: $57,445 – $75,396 USD
Benefits We are committed to creating a workplace where employees can thrive. Our best‑in‑class 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 with vacation, personal days, sick time, 11 company 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, supplemental plans, commuter benefits, family planning resources, wellness initiatives, and peer‑to‑peer recognition.
EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
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Role Overview This position is responsible for performing manufacturing procedures and executing scheduled tasks within a CGMP environment. The role focuses on quality, compliance, and maintaining the highest standards in accordance with company policies and all applicable regulations. Shift schedule: Wed‑Sat 1st Shift.
Key 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 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 appropriate PPE when working in manufacturing and other hazardous environments.
Proactively maintain a clean and safe work environment and eliminate safety hazards.
Ensure materials are available for production and support the ongoing production schedule.
Job duties require exposure to and handling of biological materials and hazardous chemicals.
Visual acuity of at least 20/40 (Snellen) without corrective lenses or corrected to 20/40 with lenses.
Color perception 5 slides out of 8.
Support the ongoing production schedule by reporting to work on‑time, performing other duties as assigned, attending meetings, practicing good interpersonal skills, promoting teamwork, learning new skills, supporting investigations, and preparing for audits.
Requirements
HS Diploma required with 3–5 years biotech/pharmaceutical experience or equivalent industry experience; OR Associate’s Degree in Life Sciences or Manufacturing with 2–3 years experience; OR Bachelor’s Degree in Life Sciences with 0–2 years experience.
Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Follow instructions and solve practical problems with limited standardization.
Perform basic arithmetic in all units of measure.
Knowledge and ability to operate manufacturing, manufacturing‑support, and lab equipment.
Knowledge of process excellence tools.
Solid knowledge of routine and non‑routine testing and sampling methods and related equipment.
Be mobile and able to transport between sites as required.
Communicate frequently with coworkers.
Ability to stand, walk, climb, bend, stoop, and reach with hands and arms.
Ability to lift 25 lbs.
Perform gowning procedures to work in manufacturing core.
Compensation Anticipated base pay range: $57,445 – $75,396 USD
Benefits We are committed to creating a workplace where employees can thrive. Our best‑in‑class 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 with vacation, personal days, sick time, 11 company 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, supplemental plans, commuter benefits, family planning resources, wellness initiatives, and peer‑to‑peer recognition.
EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
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