Operations Associate
Legend Biotech
2 hours ago
On-site
Raritan, NJ
Operations
Operations Associate, 1st Shift (Technical Operations) — Raritan, NJ
Role Overview
- Perform manufacturing procedures and execute scheduled tasks in a CGMP environment.
- Maintain quality and ensure compliance with company policies, procedures, and applicable regulations.
- Shift: 1st Shift, Wed–Sat
Key Responsibilities
- Support manufacturing of autologous CAR-T products in a controlled cGMP cleanroom.
- Independently execute manufacturing or manufacturing-support processes per SOPs/curriculum.
- Perform cell culturing, purification, aseptic processing, and cryopreservation activities.
- Execute process unit operations per SOPs and batch records; record data per Good Documentation Practices (GDP).
- Complete tasks on time in accordance with quality systems and cGMP requirements.
- Work cross-functionally to complete production tasks per shift schedule.
- Aid in manufacturing process development and documentation.
- Drive continuous improvement of manufacturing operations.
- Handle human-derived materials in containment areas.
- Support schedule adjustments to meet production.
- Complete GMP documentation (SOPs, logbooks, and other GMP records).
- Demonstrate training progression through assigned curriculum.
- Maintain working knowledge of basic cGMP requirements; follow PPE and safety requirements.
- Ensure materials are available for production; support investigations and audit preparation/participation.
Requirements / Qualifications
- HS Diploma + 3–5 years biotech/pharmaceutical experience (or equivalent) OR Associate Degree (Life Sciences/Manufacturing) + 2–3 years related experience OR Bachelor’s Degree (Life Sciences) + 0–2 years biotech/pharmaceutical experience.
- Ability to interpret instructions (written, oral, diagram, schedule) and follow instructions.
- Solve practical problems with limited standardization.
- Basic math skills (add/subtract/multiply/divide with whole numbers, fractions, decimals).
- Knowledge/ability to operate manufacturing, manufacturing-support, and lab equipment.
- Knowledge of Process Excellence Tools.
- Knowledge of routine/non-routine testing and sampling methods.
- Mobility to travel between sites; frequent communication with coworkers.
- Ability to stand/walk/climb/bend/stoop/reach; lift up to 25 lbs.
- Ability to perform gowning procedures; handle biological materials and hazardous chemicals.
Benefits (if applicable)
- Medical, dental, vision; 401(k) with company match (vests fully on day one).
- 8 weeks paid parental leave after 3 months of employment.
- Paid time off (vacation, personal, sick, floating holidays) + 11 company holidays.
- Additional voluntary benefits: flexible spending/HSAs, life/AD&D, short-/long-term disability, legal assistance, supplemental insurance, commuter benefits, family planning/care resources, well-being initiatives, peer-to-peer recognition.
Pay
- Base pay range: $57,445–$75,396 USD.
Role Overview
- Perform manufacturing procedures and execute scheduled tasks in a CGMP environment.
- Maintain quality and ensure compliance with company policies, procedures, and applicable regulations.
- Shift: 1st Shift, Wed–Sat
Key Responsibilities
- Support manufacturing of autologous CAR-T products in a controlled cGMP cleanroom.
- Independently execute manufacturing or manufacturing-support processes per SOPs/curriculum.
- Perform cell culturing, purification, aseptic processing, and cryopreservation activities.
- Execute process unit operations per SOPs and batch records; record data per Good Documentation Practices (GDP).
- Complete tasks on time in accordance with quality systems and cGMP requirements.
- Work cross-functionally to complete production tasks per shift schedule.
- Aid in manufacturing process development and documentation.
- Drive continuous improvement of manufacturing operations.
- Handle human-derived materials in containment areas.
- Support schedule adjustments to meet production.
- Complete GMP documentation (SOPs, logbooks, and other GMP records).
- Demonstrate training progression through assigned curriculum.
- Maintain working knowledge of basic cGMP requirements; follow PPE and safety requirements.
- Ensure materials are available for production; support investigations and audit preparation/participation.
Requirements / Qualifications
- HS Diploma + 3–5 years biotech/pharmaceutical experience (or equivalent) OR Associate Degree (Life Sciences/Manufacturing) + 2–3 years related experience OR Bachelor’s Degree (Life Sciences) + 0–2 years biotech/pharmaceutical experience.
- Ability to interpret instructions (written, oral, diagram, schedule) and follow instructions.
- Solve practical problems with limited standardization.
- Basic math skills (add/subtract/multiply/divide with whole numbers, fractions, decimals).
- Knowledge/ability to operate manufacturing, manufacturing-support, and lab equipment.
- Knowledge of Process Excellence Tools.
- Knowledge of routine/non-routine testing and sampling methods.
- Mobility to travel between sites; frequent communication with coworkers.
- Ability to stand/walk/climb/bend/stoop/reach; lift up to 25 lbs.
- Ability to perform gowning procedures; handle biological materials and hazardous chemicals.
Benefits (if applicable)
- Medical, dental, vision; 401(k) with company match (vests fully on day one).
- 8 weeks paid parental leave after 3 months of employment.
- Paid time off (vacation, personal, sick, floating holidays) + 11 company holidays.
- Additional voluntary benefits: flexible spending/HSAs, life/AD&D, short-/long-term disability, legal assistance, supplemental insurance, commuter benefits, family planning/care resources, well-being initiatives, peer-to-peer recognition.
Pay
- Base pay range: $57,445–$75,396 USD.