Location: London
Employment Type: Full-time, Permanent employee
Your missionThe Bioprocessing Team Leader is responsible for the execution of safe, compliant and reliable manufacturing for clinical and commercial gene therapies in MeiraGTx's Downstream manufacturing facility.
Major Activities and Responsibilities- Line manages a team of Bioprocessing Scientists providing training, support, motivation, development and performance management.
- Responsible for coordinating, organising and supporting the training of the team and the personal development of our team members.
- 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.
- Ensure on-time availability of GMP product manufactured according to the agreed manufacturing schedule.
- Work collaboratively across departments to deliver UK manufacturing performance targets and to solve problems and remove barriers constraining performance and improvement.
- Responsible for leading Quality issue first response during bioprocessing and ensuring Quality on the Shop Floor is in place to verify our facility is inspection-ready at all times.
- Responsible for ensuring our team understand the relevant safety hazards and controls for their area, that all activities are risk assessed before performing them, and that our team is protected from harm.
- Effectively communicate short-term business and operation goals, progress and updates within team.
- Champion continuous improvement within the team, providing coaching and support for team members and maintaining the continuous improvement system for the team.
- Responsible for setting and confirming high standards for quality critical manufacturing activities including, but not limited to, cleanroom behaviour, environmental monitoring, cleaning, and materials handling.
Key Performance Indicators- Prevention of injuries and incidents across the manufacturing facilities.
- Timely closure of GMP commitments (regulatory, deviations, CAPA, change Control).
- Adherence to manufacturing and supply schedule.
- Delivery of product development, clinical and launch manufacturing milestones.
- Positive regulatory inspection outcomes.
- High employee engagement and talent retention.
Key Job Competencies- Management and oversight of advanced biochemical drug substance 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.
- Strong organisation skills, planning and managing risk effectively to ensure manufacturing and project 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 Responsibilities- Lead a team of up to 12 Bioprocessing Scientists.
- Accountable for GxP compliance within Downstream processing areas.
- Accountable for safety of Downstream processing team and areas.
Job Background- University degree in Science or Engineering.
- Strong background in manufacturing operations and quality systems and understanding of process development lifecycle.
- Experience in conducting regulatory inspections and audit readiness activities.
About usMeiraGTx 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.
