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GMP Training Specialist

1 month ago

Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

Job Summary

The post-holder will be part of the Training team, responsible for training all operational GMP needs of the manufacturing site. Production team members responsible for manufacturing high quality products for use in clinical trial programmes.

Key Responsibilities

  • Train operators in multiple functions undertaking GMP activities.
  • Design and create interactive training packages.
  • Deliver engaging training both in person and virtually.
  • Deliver inductions to new starters.
  • Some activities include: cell counting, flow cytometry, sterility assays, PCR, and cell culture techniques.
  • Undertake technical knowledge transfer of new processes from the Product Development team to the Technical Operations Team through a structured training process.
  • Assist in maintaining a GMP training programme for all staff through a series of annual updates.
  • Work with external service providers where required to provide or design relevant training.
  • Any other duties as required following consultation with the post holder.
  • The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company.
  • Developing innovative training materials to capture the audience.
  • Using a Learning Management System for Curriculum Development.

Demonstrated Skills and Competencies

E – Essential

P – Preferred

  • Must meet the requirements of working in a cleanroom/aseptic environment (E).
  • Directly relevant biotechnology or pharmaceutical industry experience (P).
  • Experience of working in a busy laboratory or commercial environment (P).
  • Training development and delivery experience (E).

Qualifications

  • Degree in Biological Science discipline (P).
  • Experience in a GMP, industry or commercial field (P).

Skills/Specialist Knowledge

  • Understanding of and familiarity with GMP regulations (P).
  • Familiarity with a range of biopharmaceutical and cell-based techniques (P).
  • Strong verbal and written communication skills, communicates with credibility and confidence (E).
  • Flexible, self-motivated, and focused on team outcomes (E).
  • Excellent organisational skills with the ability to present clearly and logically (E).
  • Working co-operatively as part of a team as well as independently (E).
  • Good attention to detail and ability to accurately follow SOPs (E).
  • Ability to identify and implement solutions (E).
  • Experience of working in a GMP environment (P).
  • Generates enthusiasm and drive for commitment to excellence (E).
  • Advanced skills in the use of EXCEL and PowerPoint (E).
  • Experience in e-learning creation tools such as Articulate (P).
  • Experience and understanding of adult learning principles (E).
  • Stakeholder Management (E).