Manufacturing Training Specialist I-Senior

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  

 

The Manufacturing Training Specialist I-Senior acts as a liaison with the Quality Assurance & GMP Training Department regarding training content, delivery and metrics and ensures that activities are appropriately tracked in the Learning Management System. This role provides technical proficiency and consultative guidance as a business subject matter expert (SME) in the creation of on-the-job training materials. This position is a vital business partner who is passionate about training & committed to excellence while ensuring Manufacturing personnel are properly trained prior to performance. Collaborates with supported department to ensure training plan objectives are met through effective learning and training solutions. The role is the Manufacturing's POC (Point of Contact) for consulting on curriculum development for new or modified roles, and cross-department training projects. The Manufacturing Training Specialist, I-Senior is a role model in the organization, understanding and promoting GMP mindset and behaviors that drive a Quality Culture. This role serves as a mentor to new and current employees. 

  

PRINCIPAL RESPONSIBILITIES: 

Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.   

Collaborates with QA & GMP Training department, developing training materials for use in training courses, with high attention to quality, role-specificity, and engaging learning experience (e.g. videos, computer based training, wiki, websites, KSAs, trainee and trainer manuals, job aids, etc.) and any other general information intended to expedite on-boarding and development of personnel.   

Acts as the Manufacturing liaison working in collaboration with the QA & GMP Training department regarding: 

• Training completion and training compliance metrics/KPls ensuring that activities are appropriately tracked in the LMS. 
• Development and adherence to AGC Annual GMP Training Plan. 
• Setting up of weekly or as needed meetings with trainee, trainer, Technical & GMP Training team and supervisor to discuss progress and issues. 
• Curricula management and assignment to Manufacturing employees. 
• Training related deviation investigations, Support of internal/external training audits for the Manufacturing. 

Coordinates and conducts dynamic and interactive GMP and/or safety, classroom and/or On-The Job (OJT) training sessions on topics included in the Manufacturing Onboarding topics and any other as needed. 

Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.         

  

KNOWLEDGE, SKILLS & ABILITIES: 

MFG Training Specialist I: 

• An understanding of biopharmaceutical manufacturing process (microbial or cell culture), related equipment and purpose and function of supporting processes. 
• An understanding in the application of cGMP requirements. 
• Application of some adult learning theories and training facilitation and delivery preferred. 
• Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding. 
• Able to communicate status, needs, forecasts, risks and timelines effectively to management. 
• Displays a clear wil