Cell and Gene Therapy Operations Lead

3 weeks ago


Bristol, Bristol, United Kingdom eXmoor Pharma Concepts Limited Full time

About eXmoor Pharma Concepts Limited

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eXmoor Pharma Concepts Limited is a company that helps clients in the development and manufacture of cell and gene therapies (CGT) and biopharmaceuticals. We provide a range of services, from translation consultancy to capital project design, licensing, and GMP manufacturing for early phase clinical trials.

We are looking for an experienced GMP Production Facility Manager to join our team. This role offers a chance to work on various client projects in a rapidly growing business while developing your quality management career.

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About the Job

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  • The successful candidate will be responsible for leading the GMP production team, ensuring the efficient operation of the facility, and maintaining high-quality standards.
  • You will work closely with the Quality team to implement and maintain robust quality systems, ensuring compliance with regulatory requirements.
  • You will also be responsible for recruiting, training, and developing production staff to meet planned production needs and departmental budgets.
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Main Responsibilities

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  • Facility Operation: You will be responsible for the day-to-day operation of the facility, including maintenance, operation, qualification, validation, material storage, and waste, ensuring all are managed in compliance with the facility's stated procedures and standards.
  • Team Management: You will lead and manage the GMP production team, ensuring they have the necessary skills and resources to meet production targets.
  • Production Planning: You will lead and manage all aspects of production planning, including resource allocation, budgeting, progress reporting, and forecasting.
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Requirements

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  • MSc in Life Science or BSc with relevant years of industry experience or equivalent experience.
  • Considerable experience (5 years plus) of managing GMP clean room facilities, production, facility, and equipment qualification, quality, and GMP documentation.
  • In-depth understanding of the legislative framework of MHRA, HTA, and H&SE in Good Manufacturing Practice as applied to small-scale biopharmaceutical production for clinical trials.
  • Significant experience in a supervisory or management role, including the ability to lead, develop, motivate, and organise a small team.
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Estimated Salary: £70,000 - £90,000 per annum



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