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Johnson & Johnson Innovative Medicine · 4 hours ago

MS&T Capability Trainer, Advanced Therapies Supply Chain MS&T

Raritan, NJ

Full-time

Onsite

Mid, Senior Level

$91K/yr - $147K/yr

6+ years exp

Johnson & Johnson Innovative Medicine is a leader in healthcare innovation, focused on developing smarter and less invasive treatments. The MS&T Capability Trainer will be responsible for conducting training activities for SMEs in the cGMP Clinical and Commercial Cell Therapy Manufacturing, ensuring compliance and effective training delivery.

Pharmaceuticals

Responsibilities

Leads, coaches and delivers a holistic, effective training that supports daily production

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

Supports evaluation of appropriate compliance courses

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

Provide technical expertise to support the implementation of process improvements that would provide reduction in COGs, and increase throughout, capacity and quality compliance

Engage in Gemba walks to identify and record opportunities for process improvement and enhanced process consistency

This is not an exhaustive or comprehensive listing of job functions; May perform other duties as assigned

Qualification

CGMP environment experienceAseptic manufacturing techniqueTraining methodologyCellGene therapyManufacturing sciences knowledgeCGMP regulations knowledgeChange managementProject managementCommunication skillsProblem solving skillsTeamwork

Required

University/Bachelors Degree in Science/Engineering or equivalent experience is required

A minimum of six (6) years of experience within a cGMP environment in the biotech / pharmaceutical industry

Aseptic manufacturing technique experience is required

Hands-on experience and knowledge in manufacturing sciences and operations support is required

Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices is required

Understand key process indicators of the manufacturing process

Strong scientific and technical problem solving and critical thinking skills

Ability to lead with influence

Project management and change management

An ability to build strong partnerships with Manufacturing, Engineering and Quality organizations

Clear and succinct verbal and written communication skill

Advanced computer skills with practical knowledge of MS Office Suite tools

Highly organized and capable of working in a team environment with a positive attitude under minimal supervision

Ability to work with oversight and successfully execute and manage tasks for timely completion

Must respond to shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment