The Plasmid Technical Lead is accountable for all aspects of technical product ownership for the Plasmid manufacturing unit (PMU) at MeiraGTx Ireland. The purpose of the role is to lead the technical development, technology transfer, improvement, problem-solving, and knowledge management activities for the PMU to meet strategic and short-term business goals for the product stream.Major ActivitiesAct as MeiraGTx SME for Plasmid DNA Technical matters, acting as the lead or approver as appropriate on all aspects of GMP including but not limited to Product Lifecycle Management (ICH Q8/9/10), investigations, change control, risk assessment, specifications, capital projects, due diligence, external audits, etc.Accountability for the development and management of the PMU technical roadmap to support the PMU business development roadmap in the short, medium and long-term.Manage the PMU value stream technical resources as a matrix and/or directly to ensure that the site can deliver its PMU business strategy and ambition.Develop meaningful relationships with external experts, suppliers, and organisations to maintain at the leading edge of knowledge regarding cGMP Plasmid DNA manufacture and supply, including new and emerging regulatory standards for Plasmids used as critical starting materials.Develop and take accountability for oversight of technical relationships with external partners to deliver MSAT activities and improvements required to achieve business ambitions in the short and long term.Work closely and collaboratively with the UK & IRE Technical Services team to align best practices and procedural approaches, and to leverage knowledge and capability effectively.Oversee the coordination and alignment of technical improvement projects led by self and others to ensure projects and quality commitments are delivered to the committed plan for the business.Champion continuous improvement within the value stream, providing coaching and support for team members and improving the continuous improvement system for the team.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 right-first-time state.Key Performance IndicatorsOn-time delivery of EHS and Quality commitments – self and team.On-time delivery of technical improvement projects – self and matrix team.Continuous improvement of product quality and yield performance within PMU.Inspection readiness of technical operations, product, and process at all times.High personal standards of professionalism, integrity, empathy, and energy.High employee engagement and talent retention.Key Job CompetenciesManagement and oversight of technical scope for Plasmid DNA technical manufacturing to cGMP requirements.Management of operational health and safety in a dynamic and changing environment.Leadership, coaching and development of operational and technical teams with high potential individuals in organizations undergoing significant growth and change. Plan and manage risk effectively with strong organisation skills to ensure projects and commitments are achieved on time and in full.Strong analytical mindset, synthesizes complex information, uses intuition and experience to compliment data.Creation and embedding performance systems, establishing workflows and procedures built on simplicity, reliability, and effectiveness.Experienced with structured problem solving, identifies and resolves problems effectively and urgently; gathers and analyses information skilfully; develops alternative solutions; works very well in cross functional teams for problem solving.Fosters a continuous improvement mindset and capability within and across teams.Job ResponsibilitiesLead a team of up to five direct reports and a matrix team of up to thirty indirect reports.Financial authority for revenue spends against agreed purchase orders.Accountable for GxP compliance within Plasmid Technical Operations.Accountable for safety of Plasmid Technical Operations activities.Job BackgroundUniversity degree in Science or Engineering relevant to cGMP biopharmaceutical manufacturing.Demonstrated Technical management, delivery, and expertise within cGMP biopharmaceutical manufacturing, including product transfer and development.Demonstrated project management and change management experience within a cGMP environment.Strong background in manufacturing operations and quality systems and understanding of process development lifecycle.Highly organised and able to manage the workload and performance of others in a direct- and matrix-team environment.Strong experience with technical investigations and root cause analysis techniques.Experience in fronting regulatory inspections and audit readiness activities.Excellent communication skills – oral, written, and presentational – for technical and non-technical audiences at all levels of the organisation and external stakeholders.