QC Method Validation Manager
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 Analytical Validation manager is responsible for the validation and technology transfer of novel and established test methods for the analysis of gene therapy products and associated materials used for manufacturing the EU and FDA GMP requirements. The role involves life cycle management of assays, equipment and materials/products.
- Lead the development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.
- Serve as the subject matter expert for lifecycle management of analytical assays, equipment and materials including inprocess samples and finished products.
- Generate qualification/validation projects and associated documentation in support of the analytical activities performed ensuring compliance requirements are maintained.
- Support the set up of the QC department for the continuation of the analytical testing for clinical trial materials, commercial supply and stability studies.
- Ensure all methods are validated and performed in the QC GMP labs in compliance to regulatory standards and adheres to data integrity requirements.
- Generate master QCAR documents and implement to support all analytical methods. Ensure these are current.
- Develop and maintain stability programs for materials and products
- Responsible for the project management of test method implementation to required timescales to ensure seamless launch of new products.
- Maintain the flow of information to key stakeholders, ensure appropriate communications are passed forward and information folders are maintained with most recent versions/communications.
- Ensure the development and rollout of training on new technology/methodology introduced to the facility.
- Perform routine assessment of the analytical methods used to ensure they are being applied and are operating as expected.
- Ensure all training is undertaken in a timely manner as required to perform required activies. Support any training activities of other employees where required.
- Support with maintaining with Quality Management System and controlling of documents and ensuring the data integrity of all data produced.
- Support with all reasonable managerial requests and ad-hoc tasks.
- Ensure area compliance with Quality, Safety and Environmental systems and procedures
- Comply with MeiraGTx procedures including Health and Safety and GMP
- Ensure own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP’s, BMR’s, Protocols, Guidance’s, etc.
- Ensure own training is undertaken in a timely and GMP compliant manner before the task is undertaken
- Ensure own KPI’s, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines
Key Performance Indicators
Implementation of test methods to meet site timelines and KPI requirements
Implementation of stability programs to meet site timelines and KPI requirements
Quality control audits
Key Job Competencies
- Implement/qualify/validate analytical methods for the GMP testing of products and aspectic manufacturing facilities – understanding of regulatory requirements for analytics and stability for ATMPList key competencies to fulfil role
- Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions and works well in group problem solving situations.
- Leadership – exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
- Cost consciousness – works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.
- Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence;
- Planning/Organising – prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
- 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.
- Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
- Oral Communication – speaks clearly and persuasively in positive or negative situations; 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.
Lead a team of scientist and analysts to deliver the function on time and within budget
Degree in Human Health or Sciences equivalent relevant work experience in the pharmaceutical or other similar regulated industry (i.e. biologics).
Demonstrate significant experience in a analytical development and validation role in the pharmaceutical or other regulated industry.
Proficiency in a body of information required for the job e.g knowledge of EU and FDA regulations, GMP/GLC/GCP, Lean Manufacturing, Six-Sigma, etc.
Proficiency in IT, Microsoft Office software (Word, Excel, Powerpoint) preferred.