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
- As the Validation Specialist you will be working within the Facility Engineering department to support GMP manufacturing activities and ensure compliance with regards to the Validation program.
Major Activities and Responsibilities:
- Your role as the Validation Specialist will support the qualification activities of various equipment and systems for the manufacturing, quality control and engineering departments, within a state of the art gene therapy manufacturing facility.
- Reviewing and approving external validation documents.
- Writing of validation documents IQ/OQ/PQ.
- Overseeing the execution of validation protocols.
- Completion of validation summary reports.
- Working closely with the Engineering, Production, QC and QA departments to ensure a timely delivery of the qualification reports and the effective closure of quality records, as well as the completion of CAPAs and non-conformances generated during validation/qualification activities.
- Assisting system owners with system/equipment URS and DQ documents and using a risk-based approach to determine the appropriate validation requirements.
- Managing validation reviews, re-qualifications and revalidations to ensure maintenance of the ‘validated state’ and ongoing GMP compliance.
- Assist with CSV and GAMP compliance where required.
Key Performance Indicators
- GMP compliance of all validated equipment
- Schedule adherance
Key Job Competencies
- Problem Solving – Identifies and resolves problems in a timely manner; able to gather and analyze information; develops alternative solutions; works well in group problem solving situations.
- Leadership – exhibits confidence in self and others.
- 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.
- Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
- 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.
- Practical skills – able to carry out validation/re-qualification tasks.
Responsible for the initiation, execution and completion of validation/re-qualification documents and tasks.e.g. Number of direct reports; financial authority etc.
Qualified to Degree/H.N.C. in an engineering/validation/QA discipline.
We deal with international manufacturers on a frequent basis, and any additional languages would be an advantage but not essential.
- In Gene Therapy/Pharmaceutical background an advantage
- Excellent communication skills,
- Good organisational and planning skills.
- Good written communication and report writing skills.
- Problem solving