Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking Lead Operations Gowning Trainer as part of the Technical Operations team based in Raritan, NJ. Role Overview This position is responsible for performing training and process improvement projects for the Gown Training Program. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.
Key Responsibilities Support and lead the Gowning Training Program and be responsible for the gowning training and qualification of Manufacturing, Quality (QA), Quality Control (QC) associates for the production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.Support Gowning Training Associates with the execution of 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.Identify, develop, and implement projects that improve the quality and execution of the gowning program overall.Participate and support in correction activities to remediate Quality Investigation in relation to gowning program.Work in a team-based, cross-functional environment to complete training tasks required by shift schedule.Aid in the development of manufacturing gowning processes including appropriate documentation.Drive continuous improvement of gowning techniques and process 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 as well as the training areas.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 training schedule by: Report to work on-time and according to the shift schedule.Perform other duties as assigned.Attend departmental and other scheduled meetings.Practice good interpersonal and communication skills.Demonstrate positive team-oriented approach in the daily execution of procedures.Promote and work within a team environment.Learn new skills, procedures and processes as assigned by management and continue to develop professionally.Support investigation efforts as required.Responsible for audit preparation and participation.RequirementsHS Diploma required with 6-8 Years Biotech/Pharmaceutical experience or equivalent industry experience
ORBachelors degree required in Life Sciences or Engineering, with 0-1 years Biotech/Pharmaceutical experience or equivalent industry experienceA minimum of 4 years relevant work experience is required. Candidate must have experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems.Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.Experience with training methodology, adult learning theory, instructional design and Train-the-Trainer programs.Curriculum and module design 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.Advanced computer system skills in Microsoft Office, eLIMS, and LMS.Knowledge of Process Excellence Tools.Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.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 stoop; and reach with hands and arms.Ability to lift 25 lbs.Needs to perform gowning procedures to work in manufacturing core.
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