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Site Operations Director UK

London
Full-time
Permanent employee

Your mission

The Site Operations Director UK is accountable for the execution of  safe, compliant and reliable manufacturing and supply chain operations activities at the MeiraGTx UK facility. The role holder will optimise available capacity and its utilisation to meet the demand requirements of the MeiraGTx clinical and commercial pipeline and development milestones. They will ensure the facility develops and maintains the capabilities required to ensure a reliable clinical and  commercial supply operation, ensuring the right level of competent staff, facilities and materials are available to meet the agreed manufacturing schedule. The role holder also plays a pivotal role in the leadership of the whole of UK operations as a member of the Site Leadership Team.

Job Description

Major Activities

  • Accountable for on-time availability of GMP product manufactured in UK according to clinical and commercial timelines.
  • Accountable for execution of Supply Chain Operations to support reliable and agile manufacturing and testing operations in UK.
  • In partnership with Quality, develop and maintain a robust quality and compliance culture and performance that meets applicable regulatory standards and support regulatory inspections.
  • Establish and maintain a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment.
  • Responsible for UK manufacturing and supply chain operations workforce planning, establishing and developing internal people capability to maintain a routine, reliable GMP clinical and commercial supply operation.
  • Responsible for development and execution of UK manufacturing and supply chain operations strategy in collaboration with Quality, Tech Ops, MSAT, Ireland Operations and Senior Leadership.
  • Responsible for leading the deployment of a continuous improvement culture and systems within UK manufacturing and supply chain operations that improve quality, safety, and eliminate waste to ensure high levels of supply reliability.
  • Responsible for UK manufacturing and supply chain operations budget in collaboration with Finance
  • Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
  • Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken.
  • Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in an RFT state. 

Key Performance Indicators

  • Prevention of injuries and incidents across the manufacturing and warehouse facilities.
  • Adherence to manufacturing and supply schedule.
  • Delivery of Manufacturing and supply chain operations milestones for product development, clinical and launch programs.
  • Regulatory Inspection outcomes without major or critical observations.
  • Timely closure of GMP commitments (regulatory, deviations, CAPA, change control).
  • All GMP requirements and KPIs are met.
  • High employee engagement and retention of key talent.
 

Key Job Competencies

  • Leadership of GMP manufacturing activities in accordance with global regulatory agencies and all relevant EHS legislation.
  • Technical understanding of GMP processing, quality systems and safety management systems, with an ability to deploy new and enhanced systems that are efficient and proportionate.
  • Leadership, management, coaching and development of operational and technical teams with high potential individuals in organizations undergoing significant growth and change.
  • Management of operational resources and budgets including forecasting, optimization and strategic planning.
  • Deployment and utilization of operational excellence / lean-sigma across the organisation to deliver business performance.

Job Responsibilities

  • Responsible for UK Manufacturing and Supply Chain Operations organisation.
  • Responsible for UK Manufacturing operations and activities on GMP License (“Production Manager”).
  • Responsible for EHS within UK Manufacturing and Supply Chain operations.
  • Responsible for on-time-in-full delivery of clinical and commercial supply to the agreed schedule.
  • Responsible for UK Manufacturing and Supply Chain Operations budget.
 

Job Background

  • Bachelor’s degree or higher in relevant Science or Engineering discipline.
  • Strong leadership, oral and written communication skills.
  • 10+ years industry experience in biologics, pharmaceutical or vaccine manufacture.
  • Demonstrated success in scale-up of products from late stage development to commercial manufacture and EU/US approval.
  • Strong background in manufacturing operations and quality systems and understanding of process development lifecycle.
  • Strong record and passion for people development and effective succession planning.
  • Ability to work collaboratively with colleagues and peers from a range of functions and backgrounds in a results-driven, team-oriented environment.
  • Experience in conducting regulatory inspections and audit readiness activities.

About us

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.