Your mission
There is an immediate need to develop MeiraGTx systems and organisation to meet the requirements of a Licensed GMP commercial manufacturing organisation. The current situation is that MeiraGTx has been operating to meet Clinical supply, process development and Research and development needs of the company. This requirement will continue but the organisation will also be required to meet the needs of commercial manufacturing regulatory requirements in both London and Shannon.
Given that Gene Therapy is the newest evolution of biopharmaceutical processing it can be expected that regulatory authorities will be extremely focused on ensuring that Meira can clearly demonstrate that the company has an embedded and robust risk management strategy (ICHQ9). This strategy needs to be supported by fully operational and Validated systems.
MeiraGTx also needs to develop operational procedures and strategies that allow for closed, repeatable manufacturing processes with minimal operator interventions, digital infrastructure and records will need to be at the core of this commercialisation strategy.
The role is required to provide Validation Strategy, Guidance and oversight for the manufacture and supply of Advanced Therapies Medicinal Products (Gene Therapy viral vectors) for MeiraGTx manufacturing Facilities Shannon, Ireland & Britannia Walk London UK.
Job Description
Major Activities
- Ensuring that the site Master validation plans for MeiraGTx, Shannon and London reflect current regulatory requirements and are aligned with best practices such as ISPE.
- This role will be the key participant during site audits and inspections and must be able to clearly understand and explain all site Validation strategy and approach to regulators.
- Provide direction in relation to Validation and qualification Strategy to other departments such as Engineering, QC, automation / csv, Warehouse, QA, QAV, Tech Transfer and Manufacturing to ensure that validation standards and project plans are understood and in keeping with MeiraGTx policies and procedures.
- Provide Support and guidance to full imbed the key principles of ICH Q9 Risk Management and ICH Q8 Pharmaceutical Development across both sites.
- Elevate awareness to team members / departments about issues that could impact adherence to the qualification / validation requirements.
- Coach validation team members regarding validation / qualification best practices.
- Ensure that the standard of completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- The scope of the activities will require strategic review of all related procedures to ensure they are clear, comprehensive and they reflect current regulatory requirements.
- Prepare and execute Gap analysis of all existing process, computer systems, facility and equipment to ensure existing validation and qualification is appropriate.
- Review Change controls and Issues to ensure that any Validation impact has been addressed appropriately.
- Prepare a revalidation strategy to address additional validation as applicable.
- Travel between London and Shannon is expected to be 50:50.
- 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 Performance Indicators
To support the implementation “best practice” in validation for a new GMP Gene Therapy manufacturing facility ensuring validation of the processes, facility, utility, analytical, IT and process equipment meets regulatory requirements.
Ensure that Validation Practices are standardised across both sites as applicable.
To effectively guide the implementation of the Site Validation Master Plan, working with the engineering, operations, IT and QC teams to oversee the qualification and validation of the manufacturing facilities.
Support risk assessments to develop process validation plans and protocols with Tech Transfer, 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.
All responsibilities are performed in a timely manner, escalating any and all issues to senior management as and when they occur.
Key Job Competencies
- The Individual must have an established track record in delivering robust and regulatory compliant valid action strategies in a commercial biotechnology manufacturing environment.
- 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.
- Experience in delivery the validation responsibilities on complex capital projects.
- Demonstrated track record of building and developing teams.
- Ability to use project planning software is desirable.
Job Responsibilities
e.g. Number of direct reports; financial authority etc.
Number of direct Reports - 2
Financial authority – 0
Experience / Professional Background
Education
Minimum Qualified to Degree in Pharmaceutical Validation, engineering or Science discipline.
Languages
Experience
- Minimum 10 years experience in a Biotechnology Manufacturing site.
- Minimum 5 years in a Validation management role.
- Experience working at site management level is desirable.
#IJAdvantage
About us
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.
