Operations Gowning Trainer

Legend Biotech; Raritan (NJ); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Paid parental leave

401(k) with company match

Flexible spending and health savings accounts

Job summary

Legend Biotech is seeking an Operations Gowning Trainer I for its Raritan Training Team. This role involves performing manufacturing gowning training and maintaining compliance within a cGMP environment.

The ideal candidate will have experience in biotech or pharmaceuticals, a strong attention to detail, and the ability to work collaboratively in a team setting. Benefits include medical, dental, vision insurance, and a generous 401(k) plan.

Qualifications

• 4-6 years of biotech/pharmaceutical experience or 0-2 years with a Bachelor's degree.
• Ability to interpret and follow various instructions.
• Knowledge of routine and non-routine testing and sampling methods.

Responsibilities

• Support the Gowning Training Program for cGMP cleanroom operations.
• Execute training for manufacturing gowning activities.
• Maintain accurate documentation for training and compliance.

Skills

Problem-solving skills

Communication skills

Basic arithmetic operations

Education

HS Diploma or Bachelor's in Life Sciences/Engineering

Tools

Process Excellence Tools

Manufacturing equipment

Job description

Operations Gowning Trainer I – Raritan Training Team (Raritan, NJ)

Role Overview

This position is responsible for performing manufacturing gowning training and the execution of gowning training tasks within a CGMP environment. The trainer ensures quality and maintains the highest standards of compliance with company policies, procedures, and all applicable regulations.

Key Responsibilities

• Support the Gowning Training Program responsible for clinical and commercial operations in a cGMP cleanroom environment.
• Execute Instructor Led Trainings (ILT), qualifications, and requalification of Raritan CAR‑T personnel.
• Conduct manufacturing gowning activities to support cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
• Perform gowning training and execution that follows SOPs and batch records, and record production data according to Good Documentation Practices (GDP).
• Complete tasks on time in compliance with quality systems, cGMP, and LMS requirements.
• Work collaboratively in a cross‑functional team to complete production tasks required by shift schedule.
• Assist in developing manufacturing gowning processes and documentation.
• Drive continuous improvement of gowning techniques and processes, leveraging observations and team input.
• Support schedule adjustments to meet production and business needs.
• Maintain accurate documentation in SOPs, logbooks, GMP documents, and training events.
• Demonstrate training progression through assigned curriculum.
• Maintain a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.
• Wear appropriate PPE in manufacturing and hazardous working environments.
• Proactively maintain a clean and safe work environment, eliminating safety hazards and communicating observed unsafe behaviors.
• Ensure materials are available for qualifications and training.
• Support the ongoing production schedule by:
  • Arriving on time and following shift schedule.
  • Performing other duties as assigned.
  • Attending departmental and other scheduled meetings.
  • Practicing good interpersonal and communication skills.
  • Demonstrating a positive team‑oriented approach in daily procedures.
  • Promoting and working within a team environment.
  • Learning new skills, procedures, and processes as assigned by management and continuing to develop professionally.
  • Supporting investigation efforts as required.
  • Participating in audit preparation and execution.

Requirements

• HS Diploma required with 4–6 years biotech/pharmaceutical experience OR equivalent industry experience; or Bachelors degree required in Life Sciences or Engineering with 0–2 years biotech/pharmaceutical experience or equivalent industry experience.
• Interpret and follow a variety of instructions furnished in written, oral, diagram, or schedule form.
• Apply problem‑solving skills in situations with limited standardization.
• Perform basic arithmetic operations in all units of measure (whole numbers, common fractions, and decimals).
• Operate manufacturing, manufacturing‑support, and lab equipment.
• Use Process Excellence Tools.
• Possess solid knowledge of routine and non‑routine testing and sampling methods, techniques, and related equipment.
• Be mobile and able to transport independently between sites/locations as required.
• Communicate with coworkers frequently.
• Stand, walk, climb, bend, and reach with hands and arms as needed.
• Lift up to 25 lbs.
• Perform gowning procedures for work in the manufacturing core.

Benefits (for permanent full‑time employees only)

Medical, dental, and vision insurance; 401(k) retirement plan with company match that vests fully on day one; eight weeks of paid parental leave after three months; paid time off including vacation, personal, sick, floating holidays, and eleven company holidays; voluntary benefits such as flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability, legal assistance, and supplemental plans (pet, critical illness, accident, hospital indemnity); voluntary commuter benefits; family planning and care resources; wellbeing initiatives; peer‑to‑peer recognition programs.

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.

Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company.