Position Overview
The position will be responsible for overseeing and executing training activities for the overall plant team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will collaborate with other Training team members and in collaboration with management in Operations and Quality to support personalized cell therapy production through safe and compliant operations according to cGMP requirements.
Major Responsibilities
- Responsible to train the team members, who support cGMP clinical and commercial cell therapy manufacturing, on different topics including aseptic handling
- Support the development and execution of a holistic, effective training program for all plant functions and personnel that support daily clinical production and commercial supply of a CAR-T product
- Manages, plans, coordinates, prepares and deploys training curriculum
- Perform training assessments for new and updated procedures
- Oversee and schedule training skill checks and qualifications
- Determine and 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
- Troubleshoot problems reported by system users
- Knowledge of LMS system
- Prepares information for internal and external audits
Qualification
Education:
A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.
Experience:
A minimum of 4 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.
Capabilities, Knowledge, and skills:
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
- Advanced computer skills and practical knowledge of MS Office, SharePoint, and other related systems
- Good verbal and written communication skills
- Good educational skills
- Excellent organizational skills
- Ability to effectively prioritize and execute tasks in a fast-paced environment
- Works well in a team-oriented, collaborative environment
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision
- Proactive and continuous improvement oriented
- Ability to lead with influence
- 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
- Project management
- Change management
- Transparent, Passionate, Fearless and Accountable
