Our growing, global, Cell and Gene Therapy CDMO, Biotechnology Client is seeking a Manager, GxP Technical Site Training who will be responsible for leading the design and delivery of the GxP site training program for both the effective induction of new hires, as well as, the ongoing improvement and proficiency (i.e. cross-training) of existing employees within the site. Ensure delivery of training on a timely basis, including new hire training, cGMP documentation and regulatory basics, in addition to GLP/GDP general lab skills training. Develop training strategies that identify curriculum, training format, and evaluate training effectiveness. Work with other site trainers to ensure consistency to site training program. Manage training metrics and continuous improvement to improve metrics. 

• Determines training objectives by conducting analysis of overall needs and specific skills or knowledge gaps.
• Develops educational curricula and material and while increasing trainees’ engagement with learning sessions.
• Effectively organizes and manages multiple training initiatives simultaneously.
• Partners with the Corporate Training Department and site trainers and personnel to identify training needs and design, implement and deploy an effective, standardized, and comprehensive training program while identifying improvements to the existing training curriculum.
• Fosters a culture of continuous improvement and operational excellence. Provide guidance/support and troubleshoot issues in creative ways to help trainees feel motivated and supported Develops individualized and group training programs that address specific business needs
• Manages and delivers the Train the Trainer Program.
• Establishes and/or revises technical educational training materials including but not limited to videos, guides, SOPs, Work Instructions, and Learning Manuals. This training is not limited to GMP Documentation, Data Integrity, Quality Risk Management, and cGMPs,
• Develops a training schedule, coordinate staffing and scheduling of all training activities.
• Delivers training sessions and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
• Creates processes that enable timely and actionable performance feedback of trainees.
• Will act as Training SME for internal audits and inspection readiness activity.
• Establishes key performance indicators to measure training effectiveness. Evaluate organizational performance to ensure that training is meeting business needs and improving performance.
• Facilitates timely resolution and closeout of Corrective and Preventative actions specific to Training issues
• Evaluates Training Metrics and define improvements to ensure effective training programs.

REQUIREMENTS 

• Bachelor’s degree
• 5-10 years of experience in cGMP site training environment
• Knowledge of biopharma laboratory and/or manufacturing experience
• Knowledge of cGMP, GDocP
• Knowledge of adult learning theories and proficiency with training development; content generation, and other learning activities.
• Highly organized and capable of successfully managing multiple priorities using effective time management techniques
• Advanced experience with instructional methods, team coaching and skills development.
• Proven ability to maintain accurate recordkeeping records
• Written and oral communication skills in English; facilitate effective presentations
• Foster company values: accountable, collaborative, adaptable, and can-do spirit.
• Stays current on training methodologies, strategies, and adult learning principles.
• Obtains information and identifies key issues and relationships relevant to achieving a long-range goal or vision and organizational values.
• Identifies opportunities and taking action to build strategic relationships between one’s area and other areas, teams, departments, units, or organizations to help achieve business goals.
• Communicates a compelling and inspired vision or sense of core purpose.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey.

#IndeedPosting