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.
As the Downstream Bioprocessing Team Leader, leading a team of Bioprocessing Scientists with responsibility for all downstream processing and drug product filling activities, you will have the exciting opportunity to further develop our internal GMP clinical and commercial manufacturing capability as MeiraGTx accelerates to launch a range of advanced and transformative Gene Therapy from its London facility.
Purpose of Job
The Downstream Bioprocessing Team Leader is responsible for the execution of safe, compliant and reliable downstream manufacturing and drug product filling for clinical and commercial gene therapies in Meira’s upstream manufacturing facility.
The role holder will manage downstream manufacturing capacity and resources to meet the demand requirements of Meira’s clinical and commercial pipeline. The role holder will manage a team of scientists and manufacturing operatives with care and diligence to deliver the needs of the individual, team, and business. The role holder will plan and develop the additional capabilities required to maintain a safe, compliant and reliable operation, ensuring the right resource and capabilities are available to meet the agreed manufacturing schedule. The role holder plays a key role in the strategic development of Meira’s manufacturing capability including the qualification and licensure of the facility for commercial supply.
- Line manage a team of scientists and manufacturing operatives, providing training, support, motivation, development and performance management to ensure manufacturing goals are achieved
- Recruitment, onboarding and training of highly skilled scientists and manufacturing operatives
- Manage safety, quality and compliance activities required to keep our staff and patients safe and to satisfy all relevant regulators
- Ensure on-time availability of GMP product manufactured according to the agreed manufacturing plan (medium term) and schedule (short term)
- Work collaboratively across departments within Manufacturing, Quality, EHS, Technology Transfer, Supply Chain & Engineering 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 and compliance culture and performance level that meets applicable regulatory standards and support regulatory inspections
- Embed a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment
- Ensure the timely closure of effective risk assessments, investigations, corrective and preventative actions (CAPA) for known and potential safety and quality issues
- 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
- Develop and manage manufacturing operations budget in collaboration with Finance
Key Performance Indicators
- Prevention of injuries and incidents across the manufacturing facilities
- All GMP requirements and KPIs are met
- 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
Key Job Competencies
Management and oversight of advanced biochemical drug product manufacturing and filling 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
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.
Ability to work collaboratively with colleagues and peers from a range of functions and backgrounds in a results-driven, team-oriented environment
Experience in conducting regulatory inspections and audit readiness activities