Operations Gowning Trainer

Role Overview

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

Key Responsibilities

• Support the Gowning Training Program responsible for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
• Execute Instructor Led Trainings (ILT), Qualifications, and Requalification of Raritan CAR-T Personnel.
• Execute manufacturing gowning activities to support cell culturing, purification, aseptic processing, and cryopreservation using appropriate gowning techniques.
• Perform gowning training and execution that follows 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, cGMP, and Learning Management System (LMS) requirements.
• Work in a team based, cross-functional environment to complete production tasks required by shift schedule.
• Aid in the development of manufacturing gowning processes including appropriate documentation.
• Drive continuous improvement of gowning techniques and processes leveraging own observation as well as input of team members.
• Support schedule adjustments to meet production and business needs.
• Accurately complete documentation in SOP’s, logbooks, GMP documents, and training events.
• 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 the appropriate PPE when working in manufacturing and other hazardous working environments.
• Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
• Ensure materials are available for qualifications and training.
• Support the ongoing production schedule by:
• Reporting to work on-time and according to the shift schedule.
• Performing other duties as assigned.
• Attending departmental and other scheduled meetings.
• 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.
• Responsible for audit preparation and participation.

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 a variety of instructions furnished in written, oral, diagram or schedule form.
• Follow instructions.
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Knowledge and ability to operate manufacturing, manufacturing-support and lab equipment.
• Knowledge of Process Excellence Tools.
• Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
• Frequent mobility and ability to independently transport themselves between various sites/locations.
• Is frequently required to communicate with coworkers.
• While performing the duties of this job, the employee is regularly required to stand, walk, climb, bend and stop, and reach with hands and arms.
• Ability to lift 25 lbs.
• Needs to perform gowning procedures to work in manufacturing core.

Benefits and Paid Time Off

• Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
• Eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
• Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

Pay Range (Base Pay)

$59,168 - $77,658 USD

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.