Clinical Supply Coordinator
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.
Purpose of Job
The Clinical Supply Coordinator is primarily responsible for the following:
- Planning and coordinating all supply activities required to support Clinical programmes.
- Liaising with internal teams (Supply Chain, QA, Manufacturing, Technical, Clinical), and external parties, to ensure all supply activities are planned and executed to agreed timelines, in compliance with GMP and GDP guidelines.
- Coordinate the storage, packaging, and distribution of Drug Product, Diluent, and other items as required, to support Clinical programmes.
- Maintain accurate and up-to-date inventory records for Drug Product, Diluent, and other items as required, at all locations, including MeriaGTx facilities, Third Party storage facilities, and Clinical Sites.
- Design, build and embed new Clinical Supply Chain systems to drive excellence across the business and to improve performance.
- Liaise with internal teams to identify and agree requirements for Drug Product and Diluent to support Clinical programmes
- Plan, request, and monitor the transfer, packaging, and distribution of Drug Product and Diluent, via internal and third part service providers.
- Develop strong relationships with Clinical Operations, Supply Chain, QA, Project Management and other functions within MeiraGTx.
- Develop strong relationships with Third Party providers of storage, packaging, and distribution services.
- Manage internal and external storage capacity for Drug Product and Diluent.
- Arrange shipment of Drug Product to external locations, including partner sites and external testing sites.
- Ensure sure all export documents, licences and permits are in place to support shipments, within the UK, to EU and other European countries, to the USA, Canada, and other locations as required.
- Identify and manage risks within the Clinical Supply Chain, escalating to Supply Chain Manager for resolution as required.
- Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
- Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken
- Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state
Key Performance Indicators
- OTIF (On-time-in-full) supply of Drug Product, Diluent, and other items as required to support Clinical programmes.
- 100% accuracy maintained with regards to inventory recording & reporting for Drug Product, Diluent and other items as required.
- Cycle time recording, reporting & improvement in relation to the Clinical Supply Chain.
Key Job Competencies
- Planning/Organising – prioritises and plans work activities; uses time efficiently; contributes to the setting of goals and objectives; organises or schedules other people and their tasks; develops realistic action plans.
- Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyses information skilfully; develops alternative solutions and works well in group problem solving situations.
- Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
- Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
- Change Management – Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results
- Innovation – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
- Leadership – exhibits confidence in self and others; effectively influences actions and opinions of others
- Oral Communication – speaks clearly and persuasively in positive or negative situations; listens and seeks clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
- Written Communication – writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
- University degree or equivalent
- Experience working within a fast-paced environment, in Pharmaceutical or Biotech industries.
- Exposure to quality and regulatory systems (GMP & GDP principles).
- Knowledge and experience of International Shipping requirements.
- Proven ability to lead and influence cross-functional teams in a matrix environment.
- Highly proficient with Microsoft applications (Excel, Word, Powerpoint etc).
- Experience of ERP/MRP system would be preferred, but not essential.
- Experience of working within Clinical Supply Chains would be preferred, but not essential.