CT308_1_2020 - GMP Training Lead

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Posted: 24/12/2019 11:57
Start Date: Not Available
Salary: Competitive
Location: Stevenage
Level: Manufacturing Centre
Deadline: 21/02/2020 17:00
Hours: 37.50
Benefits: Competitive
Job Type: Permanent

Purpose of Role:

Based at the Cell and Gene Therapy Catapult manufacturing centre (CGTC-MC), the GMP Training Lead will be responsible for developing, maintaining and delivering the overall Cell and Gene Therapy Catapult manufacturing centre’s technical training strategy.  Ultimately, the GMP Training Lead is responsible for ensuring every member of CGT Catapult and hosted manufacturing organisations (“Collaborators”) is appropriately trained.  The GMP Training Lead will also lead collaborations with external training providers, as required, to develop cell and gene therapy skills training in the wider industry.

Key Accountabilities:

  • Direct report to the Head of Quality Assurance with close interaction with the manufacturing centre management team
  • Responsible for day to day management and development of a high performing GMP training team
  • Develop the manufacturing centre GMP Training and Development Technical Strategy
  • Manage resources to maintain compliance to the GMP training plan, escalate risks as required
  • Lead collaborations with third parties, including academic institutions, representing CGTC-MC and Collaborators, to develop cell and gene training programs in accordance with industry needs
  • Provide expert input and advice when developing and delivering technical training programmes for both aseptic manufacturing skills and QMS tools and techniques (e.g. root cause analysis)
  • Responsible for day to day management and development of a high performing GMP training team
  • Liaise  with the Head of HR and HR Manager – L&D Specialist to assess/identify soft skills training needs, as required

Experience:

  • Experience in interacting with the regulatory authorities
  • Knowledge of EU/MHRA regulatory environments, ideally experience of FDA regulatory requirements
  • Practical experience in establishing and/or improving site GMP training processes
  • Practical experience in performing training for GMP operations
  • Ideally, experience of working with quality processes such as deviations, change controls or corrective actions
  • Ideally, practical experience in aseptic pharmaceutical manufacturing, including performing gowning, cleaning and disinfection activities in compliance with EudraLex Vol 4, Annex 1

Knowledge / Skills / Competencies:

  • Highly motivated, pragmatic and practical to support the mission of the Cell and Gene Therapy Catapult to accelerate the development of a commercial cell and gene based therapy industry in the UK
  • Project ownership and pride in its delivery
  • Flexibility towards work assignments and new learning
  • Ability to manage multiple and varied tasks and prioritise workload with attention to detail
  • Good written and oral communication skills and presentation skills
  • Proven coaching ability
  • Experienced in training approaches, tools and techniques
  • Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives
  • Ability to quickly establish credibility and build rapport and trust

Education / Qualifications:

  • At least five years’ experience in aseptic pharmaceutical manufacturing operations
  • An understanding of adult learning principles


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