US: Training Supervisor
About The Position
Legend Biotech is seeking a Training Supervisor as part of the Operations team based in Raritan, NJ. The position will be responsible for supervising the training team who lead training activities for the overall plant team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will oversee the Training team members in collaboration with department management in Operations and Quality to support personalized cell therapy production through safe and compliant operations according to cGMP requirements. This individual will support organization build and rampup of clinical production and facility approval of a state of-the-art cell therapy facility for commercial launch and sustained production. The role will require technical experience, effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.
Requirements
- 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.
- 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.
- Good verbal and written communication 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.
- cGMP manufacturing.
- 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
Nice To Haves
- Experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems.
Responsibilities
- 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.
- Support evaluation of appropriate compliance courses.
- 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.
- Make recommendation for future system upgrades.
- Troubleshoot problems reported by system users.
- Knowledge of LMS system.
- Maintain and report quality training metrics.
- Prepares information for internal and external audits.
Benefits
- Medical, dental, and vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- Eight (8) weeks of paid parental leave after just three (3) months of employment
- Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
- Flexible spending and health savings accounts
- Life and AD&D insurance
- Short- and long-term disability coverage
- Legal assistance
- Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
- Voluntary commuter benefits
- Family planning and care resources
- Well-being initiatives
- Peer-to-peer recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
