GMP Training Specialist
2 weeks ago
At Autolus Limited, we are seeking a highly skilled and experienced GMP Trainer to join our Training team. The successful candidate will be responsible for training all operational GMP needs of our manufacturing site, ensuring that our production team members are equipped with the necessary knowledge and skills to manufacture high-quality products for clinical trial programs.
Key Responsibilities:- Design and deliver interactive training packages for GMP activities.
- Train operators in multiple functions, including cell counting, flow cytometry, sterility assays, PCR, and cell culture techniques.
- Develop and implement a GMP training program for all staff, including inductions for new starters.
- Collaborate with the Product Development team to transfer technical knowledge to the Technical Operations Team through a structured training process.
- Work with external service providers to provide or design relevant training.
- Assist in maintaining a GMP training program for all staff through a series of annual updates.
- Essential:
- Experience of working in a cleanroom/aseptic environment.
- Training development and delivery experience.
- Strong verbal and written communication skills.
- Flexible, self-motivated, and focused on team outcomes.
- Excellent organisational skills.
- Good attention to detail and ability to accurately follow SOPs.
- Preferred:
- Directly relevant biotechnology or pharmaceutical industry experience.
- Experience of working in a busy laboratory or commercial environment.
- Experience in a GMP, industry or commercial field.
- Understanding of and familiarity with GMP regulations.
- Familiarity with a range of biopharmaceutical and cell-based techniques.
- Desirable:
- Degree in Biological Science discipline.
- Experience in e-learning creation tools such as Articulate.
- Strong verbal and written communication skills.
- Flexible, self-motivated, and focused on team outcomes.
- Excellent organisational skills.
- Good attention to detail and ability to accurately follow SOPs.
- Ability to identify and implement solutions.
- Experience of working in a GMP environment.
- Generates enthusiasm and drive for commitment to excellence.
- Advanced skills in the use of EXCEL and PowerPoint.
- Experience and understanding of adult learning principles.
- Stakeholder Management.
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