Downstream Bioprocessing Team Leader
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 Downstream Bioprocessing Team Leader is responsible for the execution of safe, compliant and reliable manufacturing for clinical and commercial gene therapies in Meira’s Downstream manufacturing facility.
- Line manage a team of Senior Bioprocessing Scientists and their manufacturing operatives, providing training, support, motivation, development and performance management to ensure manufacturing goals are achieved
- Recruitment, onboarding and training of highly skilled manufacturing operatives
- 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 plan (medium term) and schedule (short term)
- Work collaboratively across departments to deliver UK manufacturing performance targets and to solve problems and remove barriers constraining performance and improvement.
- In partnership with Quality, embed and maintain a robust and positive quality culture
- Embed a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment
- Manage manufacturing workforce planning, establishing and developing a team plan and developing the team capability to enable routine, reliable GMP commercial supply operation.
- Effectively communicate business and operation goals, progress and updates within the manufacturing team.
- Lead continuous improvement initiatives that address recurring deviations, process yield opportunities, and other initiatives that improve the quality, safety, and eliminate waste and ensure high levels of supply reliability
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
- Lead a team of up to 3 supervisors and up to 20 indirect reports
- Financial authority for revenue spend against agreed purchase orders
- Accountable for GxP compliance within Downstream processing areas
- Accountable for safety of Downstream processing team and areas
- University degree in Science or Engineering
- Experience in scale-up and development of cGMP products from late stage development to commercial manufacture and regulatory approval
- Strong background in manufacturing operations and quality systems and understanding of process development lifecycle.
- Experience in conducting regulatory inspections and audit readiness activities