There is a life sciences revolution occurring being driven by the tremendous demand for cell and gene therapies. This demand coupled with the desire for collaboration, the availability of capital, regulatory mind shifts, technological developments, and bottlenecks in supply chains are creating tremendous opportunities for first movers and service providers. The Discovery Labs platform supports and drives this new environment by creating space for CGT Manufacturing, Research and Discovery and the all supporting services.
The Training Specialist will create the training program and material for the viral vector platform, as well as the training curriculums, training plans, and training documentation for the manufacturing staff. Additionally, the Training Specialist will be responsible for developing training content and performing on the job training for manufacturing aseptic technique, processes, and equipment as required. The Training Specialist is also responsible for developing and providing training presentations with subject matter experts on relevant topics, working with Manufacturing Management to develop curricula, providing measures to ensure complete understanding/proficiency, and providing support stemming from investigations.
• Directly oversees on-the-job training needs with management and outside vendors in conjunction with the site training team.
• Facilitates trainer program and conducts trainer assessments.
• Performs on-the-job training with regard to equipment/instrument set-up and troubleshooting.
• Develops and updates training requirements through job code reviews with manufacturing, quality, and site support departments.
• Coordinates development and updating of on-the-job training skill check assessment checklists.
• Creates instructor led, self read, on the job, and computer based training courses using best training resources and practices.
• Assesses training and training program content adequacy and needs. Implements continuous improvements to technical training programs, curricula, offerings, courses and/or any other training related material as the program develops or improvements are identified.
• Analyzes training trends and reviews quality data to determine opportunities for continuous improvement.
• Prepares and manages a technical training calendar and communication board. Facilitates scheduling of on-the-job training courses.
• Oversees training documentation requirements, completions, rosters, certificates, and compliance.
• Tracks and reports key quality indicators, training metrics, and participant feedback.
• Develops mechanisms using the Quality Management System to ensure operators are trained and read to execute.
• Adheres to all environmental, health and safety Standard Operating Procedures (SOPs), equipment, policies and procedures, including any department specific requirements.
• Stays current with applicable regulations including federal, state, local and company-specific practices.
• Learn, understand and apply rigorous quality standards, SOPs and Current Good Manufacturing Practices (cGMP).
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Education & Experience
Relevant Experience in GMP Manufacturing. A Bachelor's degree in an applicable field is preferred but not required. 5+ years of relevant GMP Manufacturing experience.
• 1+ years of technical training experience, including developing curriculum and writing course content.
• Knowledge of Viral Vector; Gene Manufacturing; Aseptic technique.
• History of Maintaining personnel training and training performance metrics.
• Quality training metrics.
• Thinks strategically, quickly identifies and acts on opportunities, and considers the downstream impact.
• Develops organization and seeks out new opportunities and experiences for continuous learning.
• Knowledge of cGMP and quality management systems.
• Knowledge of MS Word, PowerPoint, Excel, Outlook.
• Knowledge of instructional design, blended learning and contemporary learning methodologies preferred .
• Awareness of and ability to learn emerging learning technologies.
• Excellent written and verbal communication and interpersonal skills.
• Ability to manage, adapt to and influence change in a dynamic, high pressure environment.