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Legend Biotech · 2 days ago

Operations Process Trainer

Raritan, New Jersey, United States

Full-time

Onsite

Mid Level

$66K/yr - $87K/yr

4+ years exp

Legend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The Operations Process Trainer will be responsible for performing training activities for Operations team members supporting cGMP Clinical and Commercial Cell Therapy Manufacturing, ensuring compliance and effective training delivery.

BiotechnologyHealth CareLife ScienceOncologyTherapeutics

Responsibilities

Leads, coaches and delivers a holistic, effective training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation, Technical Support, Supply Chain) that supports daily clinical production and strategically prepares for commercial supply of a CAR-T product

Manages, plans, coordinates, prepares and performs hands-on training curriculum in areas of general use, foundational and core skills, systems, unit operations and aseptic processing

Prepares and maintains training lab, materials and equipment

Conducts Observation, Side-by-Side, and Instructor Led Training

Conducts knowledge and skill checks and independent performance qualifications for Operations

Helps write or revise SOPs/Work Instructions, knowledge and skills assessments

Performs training assessments for new and updated procedures

Identifies technical training needs and expectations, monitors progress, addresses and resolves gaps in training requirements for Operations

Supports evaluation of appropriate compliance courses for Operations

Performs training for new hires

Optimizes the effectiveness and efficiency of training program in delivery of qualified personnel

Supports investigations and evaluates improvement opportunities for effective compliant training performance leading to sustained right first-time execution

Serve as subject matter expert for Compliance & Training systems

Knowledge of LMS system

Supports the maintenance and reporting of quality training metrics

Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals

Job duties include operating an industrial vehicle; Ability to lift a minimum of 50 lbs and stand for a long period of time

Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses

Qualification

CGMP manufacturingTraining methodologyAdult learning theoryCurriculum designMS Office SuiteLearning management systemsTissue PracticesProactive improvementLeadership influenceVerbal communicationWritten communicationOrganizational skillsTeam collaboration

Required

A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required

A 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

Advanced computer skills and practical knowledge of MS Office Suite, SharePoint, and other related systems

Good verbal and written communication skills

Excellent organizational skills

Ability to effectively prioritize and execute tasks in a fast-paced environment

Works well in a team-oriented, collaborative environment

The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision

Proactive and continuous improvement oriented

Ability to lead with influence

cGMP manufacturing