Director, Training Programs  |  Just – Seattle, WA

Just is seeking a highly motivated Director of Training Programs, who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for a motivated trainer to join a fast paced, collaborative, and multidisciplinary team. This individual will join the Quality group to design, plan, implement, and oversee the Learning Management and GMP training programs ensuring compliance with cGMP standards and corporate quality standards. As a member of the Quality team you will partner with Quality and Manufacturing management teams and Subject Matter Experts to effectively design, develop and implement learning programs to ensure that all employees and contingent workers are qualified to perform their GMP responsibilities. The ideal candidate has a high attention to detail, is organized in their work, has strong written and verbal communication skills and works well independently and in teams.

Responsibilities:

  • Develop overall training strategy for GMP operations in support of initial build-out and on-going JPOD® commercial manufacturing facility
  • Design, develop, and execute training materials
  • Identifies, prioritizes, and develops approved training qualifications
  • Develops and implements instructor-led training and train-the-trainer programs
  • Collaborates with functional management teams to assess ongoing and future training and development needs as well as effectiveness of established programs
  • Evaluate training programs and leverage academic and industry partnerships for creative learning opportunities to augment internal training
  • Provides engaging communications about program information to encourage participation and highlight the value and benefits of training
  • Approves new training techniques and suggests enhancements to existing training programs.
  • Manages and develops training professionals
  • Ensure that training records are controlled, completed, and maintained appropriately according to record retention policies and the electronic QMS
  • Ensure that ongoing GMP training is conducted annually, ensuring that the training is relevant based on roles and responsibilities

Requirements:

  • BS/ BA degree in Education, Training and Development, Instructional Design, Scientific, or another relevant field is required
  • Minimum 10 years of related professional experience developing and delivering training materials
  • Minimum 5 years of experience in a regulated environment
  • Working knowledge of cGMP is required, including ability to understand and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance
  • Communication and presentation skills, delivering training in an engaging and consistent manner

Preferred qualifications:

  • Excellent technical writing, attention to detail and organizational skills
  • Coaching and willingness to develop others

Ability to influence and persuade to drive quality culture

    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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