Operations Gowning Trainer
Legend Biotech
August 07, 2026
On-site
Raritan, NJ
Operations
Role Overview
- Perform manufacturing gowning training and execute gowning training tasks within a cGMP environment, ensuring quality and compliance with company policies, procedures, and applicable regulations.
Key Responsibilities
- Support the Gowning Training Program in a controlled cGMP cleanroom.
- Execute Instructor-Led Trainings (ILT), Qualifications, and Requalification for Raritan CAR-T personnel.
- Perform manufacturing gowning activities supporting cell culturing, purification, aseptic processing, and cryopreservation.
- Follow SOPs and batch records; record production data per Good Documentation Practices (GDP).
- Complete tasks on time per quality systems, cGMP, and Learning Management System (LMS) requirements.
- Work cross-functionally with the shift schedule; support development of gowning processes and documentation.
- Drive continuous improvement of gowning techniques/processes; support schedule adjustments.
- Maintain documentation in SOPs, logbooks, GMP documents, and training events; demonstrate training progression.
- Maintain knowledge of basic cGMP requirements; wear appropriate PPE; maintain a clean/safe environment and act on hazards.
- Ensure materials are available for qualifications/training.
- Support the production schedule (on-time reporting, other duties, meetings, communication, and teamwork).
- Support investigation efforts and participate in audits.
Requirements
- HS Diploma + 4–6 years biotech/pharma experience (or equivalent) OR Bachelor’s in Life Sciences or Engineering + 0–2 years biotech/pharma experience (or equivalent).
- Ability to interpret and follow written/oral/diagram/schedule instructions; solve practical problems with limited standardization.
- Basic math skills; knowledge to operate manufacturing/lab equipment.
- Knowledge of Process Excellence Tools; testing/sampling methods and related equipment.
- Mobile; communicate with coworkers; physically able to stand/walk/climb/bend/reach; lift 25 lbs.
- Perform gowning procedures for manufacturing core.
Benefits and Paid Time Off
- Medical, dental, and vision; 401(k) with company match (fully vested day one).
- 8 weeks paid parental leave after 3 months employment; paid time off (vacation, personal, sick, floating holidays) and 11 company holidays.
Pay Range (Base Pay)
- $59,168 USD – $77,658 USD
Application instructions
- Applicants must be authorized to work in the United States; participate in E-Verify and complete Form I-9 if selected.
- Perform manufacturing gowning training and execute gowning training tasks within a cGMP environment, ensuring quality and compliance with company policies, procedures, and applicable regulations.
Key Responsibilities
- Support the Gowning Training Program in a controlled cGMP cleanroom.
- Execute Instructor-Led Trainings (ILT), Qualifications, and Requalification for Raritan CAR-T personnel.
- Perform manufacturing gowning activities supporting cell culturing, purification, aseptic processing, and cryopreservation.
- Follow SOPs and batch records; record production data per Good Documentation Practices (GDP).
- Complete tasks on time per quality systems, cGMP, and Learning Management System (LMS) requirements.
- Work cross-functionally with the shift schedule; support development of gowning processes and documentation.
- Drive continuous improvement of gowning techniques/processes; support schedule adjustments.
- Maintain documentation in SOPs, logbooks, GMP documents, and training events; demonstrate training progression.
- Maintain knowledge of basic cGMP requirements; wear appropriate PPE; maintain a clean/safe environment and act on hazards.
- Ensure materials are available for qualifications/training.
- Support the production schedule (on-time reporting, other duties, meetings, communication, and teamwork).
- Support investigation efforts and participate in audits.
Requirements
- HS Diploma + 4–6 years biotech/pharma experience (or equivalent) OR Bachelor’s in Life Sciences or Engineering + 0–2 years biotech/pharma experience (or equivalent).
- Ability to interpret and follow written/oral/diagram/schedule instructions; solve practical problems with limited standardization.
- Basic math skills; knowledge to operate manufacturing/lab equipment.
- Knowledge of Process Excellence Tools; testing/sampling methods and related equipment.
- Mobile; communicate with coworkers; physically able to stand/walk/climb/bend/reach; lift 25 lbs.
- Perform gowning procedures for manufacturing core.
Benefits and Paid Time Off
- Medical, dental, and vision; 401(k) with company match (fully vested day one).
- 8 weeks paid parental leave after 3 months employment; paid time off (vacation, personal, sick, floating holidays) and 11 company holidays.
Pay Range (Base Pay)
- $59,168 USD – $77,658 USD
Application instructions
- Applicants must be authorized to work in the United States; participate in E-Verify and complete Form I-9 if selected.