Group Leadership Development Manager at Genuit influencing leadership development through strategic design and trusted consultancy within complex organisations.
About the role
- GMP Training Specialist designing, developing, and implementing training for aseptic manufacturing-related processes. Driving continuous improvements and collaborating within a global team environment.
Responsibilities
- This position is the primary trainer for cGMP, cGDP, contamination control and aseptic behavior as it relates to aseptic manufacture of biologic products and materials
- Designs, develops and implements curricula, and conducts training for monoclonal antibodies drug product manufacturing, and biologics packaging in compliance with site procedures and global standards
- Identify and drive continuous process improvements related to GMP and aseptic training
- Continuously improve and innovate training execution and management
- Conducts audits/reviews of personnel to evaluate training effectiveness
- Makes decisions that are in accordance with company policies and SOPs, Core Values, and global regulatory guidelines (including cGMP/cGDP/cGLP), environmental guidelines
- Learning Management System administration (SAP SuccessFactors)
- Facilitate New Employee Orientation (including cGMP/cGDP/cGLP), and aseptic training for initial and refresher training for site personnel, including gowning qualification and classroom process simulations
- Coordinates required annual training requirements with department management
- Conducts spot checks/audits of aseptic techniques and behaviors during operations
- Observes aseptic process simulations (media fills) for aseptic practices and best practices
- Network with the Global Aseptic Team to share best practices
- Liaison with colleagues to ensure they are trained and understand the criticality of the aseptic process work they are conducting
- Coordinates personnel training using available technology, including, but not limited to, virtual reality technology
- Integrates training sessions and training documentation into electronic training document management systems
- Collaborate with area Operations Team Leaders to train and lead colleagues in the performance of best practices
- Collaborate with QC to analyze training techniques and instructions for error prone testing
- Collaborate with QA to analyze training techniques and instructions for incidents with patterns and trends
Requirements
- BS with 2-4 years of experience OR MS with 0-2 years of experience related to aseptic manufacturing
- Bachelor’s Degree in Engineering, Biology, Chemistry, Microbiology, Virology, Immunology, or related technical field
- Must have strong technical/analytical skills and possess a high degree of personal motivation
- Excellent interpersonal skills and ability to interact across divisional boundaries
- Familiar/proficient in adult learning methodologies
- Strong technical writing skills
- Preferred experience in aseptic and biological product formulation (blend/fill/lyophilization), packaging, and/or testing.
- A working knowledge of vaccine production methods and experimental design
- Experience in GLP or cGMP
- Knowledge of FDA, APHIS, VMD, USDA regulations applicable to the Pharmaceutical/Biological industry
- Preferred experience in Lean/Six Sigma
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible working arrangements
- Professional development
- Bonuses
- Equipment allowances
- Wellness programs
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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