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 maintaining 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.
- 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.
- BS/ BA degree in Education, Training and Development, Instructional Design, Scientific, or another relevant field is required
- 5-7 years of professional experience developing and delivering training in a biologic pharmaceutical manufacturing 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
- 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