Major Activities 

• 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 in-process samples and finished products. 
• Generate qualification/validation projects and associated documentation in support of the analytical activities performed ensuring compliance requirements are maintained. 
• Ensure all methods are validated and performed in the QC GMP labs in compliance to regulatory standards and adheres to data integrity requirements. 
• Support Validation of Methods for raw Materials testing & sampling booth activities. 
• Responsible for the project management of test method implementation to required timescales to ensure seamless launch of new products. 
• Responsible for ensuring any external testing activities meet GMP requirements. 
• 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. 
• Support any training activities of other employees where required. 
• Support with maintaining 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 KPl’s plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines. 
• Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures. 
• Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken. 
• Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state. 

Key Job Competencies

• Implement/qualify/validate analytical methods for the GMP testing of products and aseptic manufacturing facilities - understanding of regulatory requirements for analytics and stability for ATMPs.  
• 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.  

Job Background

• 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 validation role in the pharmaceutical or other regulated industry. 
• Must have previously managed a team of people. 
• Proven ability to deliver key projects on time. 
• You are independent, enthusiastic, goal-oriented, efficient, and accurate, and enjoy working in a fast-paced environment. 
• You can run several projects in parallel and working in a flexible way. 
• 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. 
• Must be willing to travel between the two MeiraGTx sites.