Site Operations Director UK in London

Your mission is to ensure safe, compliant and reliable manufacturing and supply chain operations at the MeiraGTx UK facility. The role holder will optimise available capacity 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 for a reliable clinical and commercial supply operation, ensuring 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 UK operations as a member of the Site Leadership Team.

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 that meets applicable regulatory standards.
• Establish and maintain a safety-first culture emphasizing individual accountability and safe systems of work.
• Responsible for UK manufacturing and supply chain operations workforce planning and developing internal people capability.
• Responsible for development and execution of UK manufacturing and supply chain operations strategy in collaboration with various departments.
• Lead the deployment of a continuous improvement culture within UK manufacturing and supply chain operations.
• Manage the UK manufacturing and supply chain operations budget in collaboration with Finance.
• Ensure compliance with GMP, Data Integrity and Good Documentation Practice (GDP).
• Ensure timely training of self and team in a GMP compliant manner.
• Ensure timely closure of GMP documentation within own area of responsibility.

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.
• Regulatory Inspection outcomes without major or critical observations.
• Timely closure of GMP commitments.
• 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.
• Technical understanding of GMP processing, quality systems and safety management systems.
• Leadership, management, coaching and development of operational and technical teams.
• Management of operational resources and budgets including forecasting and strategic planning.
• Deployment of operational excellence / lean-sigma across the organisation.

Job Responsibilities

• Responsible for UK Manufacturing and Supply Chain Operations organisation.
• Responsible for UK Manufacturing operations and activities on GMP License.
• Responsible for EHS within UK Manufacturing and Supply Chain operations.
• Responsible for on-time-in-full delivery of clinical and commercial supply.
• 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.
• Strong background in manufacturing operations and quality systems.
• Strong record and passion for people development and effective succession planning.
• Ability to work collaboratively 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.