Operations Gowning Trainer
Legend Biotech
August 29, 2026
On-site
Raritan, NJ
Operations
Role Overview
Perform manufacturing gowning training and execute gowning training tasks within a CGMP environment, maintaining quality and compliance with company policies, procedures, and applicable regulations.
Key Responsibilities
- Support the Gowning Training Program for clinical and commercial operation in a controlled cGMP cleanroom.
- Execute Instructor Led Trainings (ILT), Qualifications, and Requalification of Raritan CAR-T personnel.
- Perform 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 in a cross-functional, team-based environment to meet shift schedules.
- Aid development of gowning processes and documentation; drive continuous improvement.
- Support schedule adjustments; ensure materials are available for qualifications/training.
- Complete documentation (SOPs, logbooks, GMP documents, training events) and demonstrate training progression.
- Maintain knowledge of basic cGMP requirements; wear appropriate PPE; promote safe, clean work environment.
- Support investigations and audit preparation/participation.
Requirements
- HS Diploma with 4–6 years biotech/pharma experience (or equivalent) OR Bachelor’s in Life Sciences/Engineering with 0–2 years biotech/pharma experience.
- Ability to interpret and follow instructions; solve practical problems with limited standardization.
- Basic math (add/subtract/multiply/divide).
- Knowledge to operate manufacturing/manufacturing-support/lab equipment; Process Excellence Tools.
- Knowledge of routine/non-routine testing and sampling methods and equipment.
- Mobile; frequently communicate with coworkers; able to stand/walk/climb/bend/reach; lift up to 25 lbs.
- Perform gowning procedures for manufacturing core.
Benefits
Medical, dental, vision; 401(k) with company match (vests day one); 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays). Performance-based bonus and/or equity may be available.
Application Instructions
Applicants must be authorized to work in the United States.
Perform manufacturing gowning training and execute gowning training tasks within a CGMP environment, maintaining quality and compliance with company policies, procedures, and applicable regulations.
Key Responsibilities
- Support the Gowning Training Program for clinical and commercial operation in a controlled cGMP cleanroom.
- Execute Instructor Led Trainings (ILT), Qualifications, and Requalification of Raritan CAR-T personnel.
- Perform 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 in a cross-functional, team-based environment to meet shift schedules.
- Aid development of gowning processes and documentation; drive continuous improvement.
- Support schedule adjustments; ensure materials are available for qualifications/training.
- Complete documentation (SOPs, logbooks, GMP documents, training events) and demonstrate training progression.
- Maintain knowledge of basic cGMP requirements; wear appropriate PPE; promote safe, clean work environment.
- Support investigations and audit preparation/participation.
Requirements
- HS Diploma with 4–6 years biotech/pharma experience (or equivalent) OR Bachelor’s in Life Sciences/Engineering with 0–2 years biotech/pharma experience.
- Ability to interpret and follow instructions; solve practical problems with limited standardization.
- Basic math (add/subtract/multiply/divide).
- Knowledge to operate manufacturing/manufacturing-support/lab equipment; Process Excellence Tools.
- Knowledge of routine/non-routine testing and sampling methods and equipment.
- Mobile; frequently communicate with coworkers; able to stand/walk/climb/bend/reach; lift up to 25 lbs.
- Perform gowning procedures for manufacturing core.
Benefits
Medical, dental, vision; 401(k) with company match (vests day one); 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays). Performance-based bonus and/or equity may be available.
Application Instructions
Applicants must be authorized to work in the United States.