AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

 

SUMMARY:

The Sr. Manufacturing Training Specialist 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. The (Sr.) Manufacturing Training Specialist 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 (Sr.) Manufacturing Training Specialist is a role model in the organization, understanding and promoting GMP mindset and behaviors that drive a Quality Culture. The Sr. Manufacturing Training Specialist is 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 SEA 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:

  • Strong, detailed knowledge and understanding of biopharmaceutical manufacturing process (microbial or cell culture), related equipment and purpose and function of supporting processes.
  • Strong knowledge in the application of cGMP requirements.
  • Application of 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 willingness to listen to others. Has good interpersonal skills and works interdepartmentally in an effective manner to achieve objectives.
  • Shows commitment and dedication and strives to be ahead of schedule.
  • Practices safety awareness at all times and considers impact of actions prior to executing activities.
  • Is passionate for training and to train others.
  • Must be computer literate and able to effectively use the full MS Office suite of applications

 

EDUCATION/EXPERIENCE:

  • B.A. or B.S. or relevant work experience preferred area of study: Life Sciences or Education.
  • Minimum of 5-7 years of relevant biopharmaceutical manufacturing experience (Senior 8-12) and 2 years of training/education and delivery of technical topics within biopharmaceutical manufacturing companies preferred.  Equivalent education and experience may substitute for stated requirements

 

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any
other characteristic protected by applicable laws, regulations and ordinances

 

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