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.
