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GMP Manufacturing Training Specialist

Employer
Paragon Gene Therapy, a unit of Catalent Biologics
Location
Harmans, MD, US
Start date
Apr 17, 2019

View more

Discipline
Administration, Clinical, Clinical Medicine
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital

Job Details

Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

The OJT Specialist's core responsibility is to assist the Manager of On the Job Training with the implementation of GMP training for Manufacturing employees. The OJT Specialist is also responsible for developing and providing training presentations with subject matter experts on relevant topics, providing measures to ensure complete understanding/proficiency, and performing deviation investigations stemming from GMP operations. The Manufacturing Training Specialist will interact with individuals at multiple levels within all functional departments at Paragon.

The goal of this role is to ensure On the Job Training and associated procedural documentation provides clear guidance for the Manufacturing staff as well as implementing process improvements based on results from deviation investigations.

Key Roles & Responsibilities include but are not limited to:

Training: Design, Develop and Deliver Training
  • Utilize training standards (standards in the Paragon Training Program procedure) to develop and design robust training that will provide knowledge to transfer learning to the workplace
  • Draft On the Job Training Curricula
  • Draft, revise, or develop training procedure manuals, job aids, SOPs, or course material such as handouts and visual materials
  • Develop and deliver training presentations on pertinent topics to Manufacturing groups on an as needed basis
  • Embeds in training design and delivery GMP practices, and an explanation of WHY
  • Possesses the knowledge of adult learning theory, training delivery and how to meet the needs of the learner
  • Utilize metrics to establish the success or outcome of the training (# deviations, human error)
  • Communicate with Manufacturing Management and QA teams on an ongoing basis to support site Training needs
  • Ability to drive the behavior to follow controlled documents and create a GMP culture
  • Be agile to meet the demands of the CDMO business and current best practices
  • Interact with auditors to explain company training policies and materials

Experience & Education:
  • Bachelors degree and 4+ years of experience within the biologic, pharmaceutical or medical device industry with responsibilities for performing and/or developing or delivering training to colleagues OR
  • Associates degree and 7+ years of experience within the biologic, pharmaceutical or medical device industry with responsibilities for performing and/or developing or delivering training to colleagues
  • Familiarity with electronic systems, including Microsoft Access and Excel
  • Excellent written and verbal communication skills
  • Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine Manufacturing operations
  • Train the trainer experience is preferred

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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Company

Company info
Location
801 West Baltimore Street
Suite 302
Baltimore
Maryland
21201
US

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