Training Program Manager  | Seattle, WA

Just is seeking a highly motivated Training Program Manager who desires a significant opportunity to improve worldwide access to biotherapeutics. This individual will report to the Training Program Director and be on the forefront of implementing a GMP training system for a new state-of-the art biologic pharmaceutical manufacturing facility. As a member of the Quality team you will partner with leadership and Subject Matter Experts throughout the organization to design, develop, implement, and evaluate learning programs. You will enable personnel throughout the organization to learn how to perform their work consistently right first time through effective training, while ensuring all employees and contingent workers are compliant with regulatory and corporate quality standards. The ideal candidate will: be detail oriented and organized, possess strong written and verbal communication skills, be able to transform complexity into manageable learning opportunities through intelligent instructional design, work well both independently and in teams, thrive at managing multiple competing priorities, and be a role-model for promoting a GMP mindset through behaviors that drive a Quality culture.

Responsibilities:

  • Engage with department personnel to understand their business challenges, identify their training needs, and develop effective learning solutions.
  • Work with Subject Matter Experts to create dynamic training materials for technical processes, systems, and equipment used in the cGMP production of clinical and commercial biologic pharmaceuticals.
  • In collaboration with leadership and SMEs, coordinate and conduct interactive classroom training sessions on topics including, but not limited to, introductory level GMP training for new personnel, Manufacturing On-Boarding topics, and department specific GMP topics.
  • Establish, maintain, and report on metrics to measure training effectiveness.
  • Review changes to controlled documents to assess training impact.
  • Monitor and manage personnel training assignments.
  • Ensure training records are completed, processed, and maintained according to record retention policies and the electronic QMS.

Requirements:

  • BS/ BA degree in Education, Training and Development, Instructional Design, Scientific, or another relevant field is required
  • 3-5 years of related professional experience developing and delivering training in a regulated environment
  • Strong knowledge of and experience with the application of cGMP requirements, biopharmaceutical manufacturing processes, and purpose and function of supporting processes
  • Detailed knowledge and understanding of adult learning theory and instructional design methodologies
  • Communication and presentation skills, delivering training in an engaging and consistent manner

Preferred qualifications:

  • Technical writing, instructional design, eLearning authoring, training video production
  • Attention to detail and organized
  • Train-the-trainer experience, coaching and willingness to develop others
  • Ability to work under time constraints and deadlines with potential workload changes and competing demands
  • Experience navigating and managing various modules in a Quality Management System software suite.
  • Previous industry experience in GMP biologic pharmaceutical manufacturing

About Just – Evotec Biologics

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just’s focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle’s South Lake Union neighborhood – the center of Seattle’s medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just’s innovative platform and footprint – building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers

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