Technical Transfer Specialist – Process Validation
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
To establish and lead the processes required to carry out validation of manufacturing processes and methods in line with ICHQ8-10.
To support the organisation and processes for project management and technical support in product lifecycle management activities (BLA, Product Launch).
- Responsible for establishing and leading process validation of processes in line with ICHQ8-10.
- Project leadership/management and formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, launch and subsequent lifecycle management.
- Develop technical subject matter expertise in the technical support team and wider manufacturing operations.
- Lead and/or provide technical support using established problem solving techniques for investigations into quality events. Provide technical recommendations, co-ordinate and execute CAPA’s.
- Management of change controls; providing impact assessments as a technical functional, coordinating input and support from development if required. Lead/support and/or coordinate the action plans.
- 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
Main Team Activities
- Provision of technical expertise for planned activities and unplanned business issues.
- Co-ordinate and participate in cross functional teams to complete root cause analysis using established problem solving techniques. Reporting and presenting findings, outcomes and recommendations.
- Manage and/or support process and analytical transfers for any transfers from development, CMOs and partners into MeiraGTx manufacturing/testing facilities
- Leading the development and continuous improvement of manufacturing and analytical techniques for life cycle management in accordance with GxP, regulatory requirements and company policies and procedures.
- Author/review/execution process validation and performance qualification protocols for manufacturing processes.
- Author/review of relevant CMC sections of regulatory dossiers and support regulatory compliance initiatives including gap analysis, responding to RFIs, regulatory incidents and post approval commitments.
- Contribute to the technical strategy for the product portfolio.
- Reports to Head of Technology Transfer.
- Works cross functionally as a strong leader and establish effective partnerships with functional leads in development, quality and manufacturing.
- Acts as a point of contact for the technical information in manufacturing and methods with clear understanding of the strengths of the developing SME network and how to access and use it.
- To work closely with the selected suppliers of raw materials and equipment during the development, tech transfer and implementation of new products, continuing through the life cycle management of existing products.
- Management and coordination of expert external resources.
Key Job Competencies
- 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.
- 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.
- Commercial acumen– gets involved in strategic decision-making within the business as an influencer. Able to understand company finances, resourcing and the ultimate aims of the business
- Change Management – Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
- 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/Organizing – 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.
- Innovation – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
- 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.
- Scientific Degree or equivalent, preferably with a higher qualification in a discipline related to bio-pharmaceutical sciences.
- Extensive industrial experience in Pharma/Bio within a GMP regulated environment.
- Experience of transferring pharmaceutical products from Development into a GMP manufacturing environment, successfully gaining approval and launching new products commercially.
- Demonstrated interpersonal skills with ability to work cross-functionally both with internal and external partners.
- Excellent communication skills.
- Knowledge of the Regulatory compliance requirements within Europe and the USA.
- Demonstrated experience in the management of root cause analysis investigations utilising Lean/Six Sigma tools.
- Ability to manage, multiple, cross functional projects to deliver against key project milestones and deadlines.
- Experience of managing workload of small teams to meet deadlines.
- Excellent verbal and written communication skills, in English.
- Ability to present effectively to groups.
- Excellent influencing skills and ability to establish effective working relationships with personnel at all levels.
- Thorough working knowledge of ICH guidelines and current Good Manufacturing Practices.