Quality Control – Analytical Stability 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 Quality Control – Analytical Stability Coordinator, will be responsible for managing and coordinating MeiraGTx Quality Control stability programmes for the manufactured gene therapy products.
- Set up, manage and coordinate stability programmes within Quality Control.
- Ensure timely completion of stability timepoints within the necessary testing windows.
- Draft and review stability protocols and reports.
- Perform a QC review of stability associated documentation (i.e., analytical methods and forms).
- Track and trend stability data and highlight any observable trends.
- Identify, raise, and investigate any out of specification/ trend and or aberrant results.
- Collaborate with QC Analytical team lead to ensure the necessary resource is allocated to each stability timepoint.
- Comply with MeiraGTx procedures including Health and Safety and GMP.
- Ensure the necessary stability samples are shipped to the correct external test sites.
- Oversee external contractors and the smooth transition of samples, analysis, and data.
- Liaise with external contractors to review and approve externally generated data.
Key Performance Indicators
- Timely completion of stability timepoints.
- External analysis is scheduled and performed within testing windows.
- Timely completion of Quality Events/ Documentation.
Key Employee Competencies
- A high Level of attention to detail.
- Problem Solving – Identifies and resolves problems in a timely manner; able to gather and analyse information; develops alternative solutions; works well in group problem solving situations.
- Leadership – exhibits confidence in self and others when leading a team of people and managing processes.
- Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
- Planning/Organizing – prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives.
- Professionalism – approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
- Innovation – meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
- Oral Communication – speaks clearly; listens and gets 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.