QA Associate, Validation and Tech Transfer
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 role is required provide QA support for the manufacture and supply of Advanced Therapies Medicinal Products (Gene Therapy viral vectors).
The role will provide QA support for all validation and qualification activities across the Manufacturing facility and Laboratories at MeiraGTx. To ensure processes, analytical methods and equipment are appropriately validated and qualified in accordance with EU and FDA regulations and MeiraGTx policies.
- Interface with other departments such as Engineering, QC, Operations, Warehouse and MSAT (Process Development) to ensure that validation project plans are understood and in keeping with site objectives.
- Review and approve tech transfer, validation, qualification protocols and reports.
- Deputise for line manager as directed.
- Maintain understanding of cGMP, Good engineering practices and guidance in relation to all aspects of validation across manufacturing, analytical laboratories and facilities.
- Support the generation of Process Validation, Analytical Method Validation and Equipment Installation, and Operational and Performance Qualifications, review and approve the Qualification protocols, discrepancies and reports for Quality.
- Interface with external consultants and partners as directed by QA Specialist, Validation & Tech Transfer, suppliers and contractors to ensure successful process and equipment validation.
- Provide QA support to data integrity compliance activities across the site.
- Write or assist in writing of MeiraGTx Policies, SOPs, work instructions and forms for validation requirements and other quality systems as required.
- Maintenance and archiving of Validation documentation.
- Support Regulatory Inspections and third party audits.
Key Performance Indicators
- To support the implementation “best practice” in validation for a new GMP Gene Therapy manufacturing facility ensuring validation of the processes, analytical methods and equipment meets regulatory requirements.
- To effectively implement the Site Validation Master Plan, working with the engineering, operations and QC teams to oversee the commissioning; qualification and validation of the manufacturing facility and supporting activities.
- Participate in risk assessments to develop process validation plans and protocols with Develeopment, Operations and QC staff.
- Implement robust and ‘fit for purpose’ validation procedures ensuring the facility, equipment, and processes are validated, qualified and maintained to regulatory requirements.
- Review the Quality Assurance of aseptic processing and capabilities, ensuring aseptic qualification of staff and the manufacturing facility meeting GMP requirements.
- All responsibilities are performed in a timely manner, escalating any and all issues to senior management as and when they occur.
- Recommend improvement in validation management practices and documents.
Key Job Competencies
- The individual must have an established track record in delivering robust and regulatory compliant Tech Transfer and Validation Plans and Protocols
- Extensive experience of GxP compliance requirements.
- Able to Interact with other departments and personnel across the business both orally and in writing, demonstrating good interpersonal skills.
- Can identify and escalate issues to line management, to ensure workload is prioritised, issues are highlighted to ensure business needs are met.
- Able to respond flexibly and adapt to the needs of the department/wider business, demonstrating good organisational and time management skills.
Job Background Education
- BSc in Science / Engineering
Languages – English
- The successful candidate must have experience in GMP manufacture of parenteral products, with an emphasis on aseptic manufacturing.
- Experience of GMP manufacturing requirements, the validation of facilities, processes, equipment and analytical methods.
- Experience in using risk assessment tools including FMEA
- Ability to balance needs of the business with the needs of the Regulatory challenges