Education: Bachelor's degree
Experience: 6+ years
- Leads, directs, coaches and develops a holistic, effective training program for all plant functions and personnel that support daily clinical production and strategically prepares for commercial supply of a CAR-T product.
- Manages training team to plan, coordinate, prepare and deploy training curriculum.
- Perform training assessments for new and updated procedures.
- Oversee and schedule training skill checks and qualifications.
- Leads and works with training team to manage training requirements for new hires.
- Work collaboratively with functional leads for procedure alignment based on roles.
- Serve as subject matter expert for Compliance & Training systems.
- A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.
- A minimum of 6 years relevant work experience is required. It is preferable that the candidate 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.
- Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
- Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
- Advanced computer skills and practical knowledge of MS Office Suite, SharePoint, and other related systems.
- Ability to effectively prioritize and execute tasks in a fast-paced environment.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
- Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
- Strong analytical, problem solving and critical thinking skills.
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