QC Specialist 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
As the QC specialist/team lead, you will be responsible for ensuring continued Good Manufacturing Practice (GMP)-compliant activities within QC to support the manufacture and release of plasmid and gene therapy products.
The role will involve setting up and managing the QC testing required for the Shannon facility, including equipment purchase, method transfer, recruitment and people management.
- Manage and grow a team to perform analytical testing, review and approve Quality Control documentation. ensuring timely release of GMP compliant product in accordance with product specifications.
- Write and review procedures required to support QC in Shannon.
- Introduce equipment for the Ireland facility including supporting URS, IQ,OQ,DQ documentation.
- Manage shipping and testing at external contract testing houses for raw materials and final product.
- Perform internal testing for plasmid and vector manufacture.
- Main point of contact for QC on-site in Shannon facility, for analytical and microbiology.
- Provides key input on analytical and microbiological technology transfer plans and method transfers.
- Write QC quality records as appropriate (Deviation, change control, OOS, CAPA).
- Create, Track, trend and report QC KPI’s.
- To be responsible for conducting audits within the quality control group, ensuring compliance is maintained at all times.
- Key member of the QC team involved in regulatory inspections of the Shannon facility.
- Management of QC documentation storage and retention in line with site procedures.
- Propose and/or Support the development and implementation of continuous improvement programmes.
- Promote appropriate, effective communication within the team, with members of other departments, and with external collaborators.
- Provides ongoing coaching and mentoring to direct reports/junior analysts as needed.
- Contribute to cross departmental activities and providing expert advice where needed.
- Assure the data integrity of all activities is performed.
- Identify and report procedural problems and deviations.
- Ensure area compliance with Quality, Safety and Environmental systems and procedures.
- 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.
Key Performance Indicators
- GMP compliance
- Quality Control KPI’s
- Data integrity
Key Job Competencies
- Experience of working within a quality environment.
- Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness
- A high Level of attention to detail
- Problem Solving – Identifies and resolves problems in a timely manner; able to gather and analyse information; develops alternative solutions; works well in group problem solving situations
- Leadership – exhibits confidence in self and others when leading a team of people and managing processes
- 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
- 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
- Innovation – meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas
- Oral Communication – speaks clearly; 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
- Physical & mental requirements – occasional lifting; the noise level in the work environment is usually moderate
Manage a Team to deliver QC testing
Ensure GMP Compliance
- BSc in a scientific discipline
- Minimum 5 years experience working in a GxP environment
- Experience of working in more than one aspect of QC, e.g. Raw materials, analytical testing, equipment validation, method validation
- Experience in working with gene therapy or biologics methods e.g. qPCR, HPLC, Western blot, SDS PAGE, DNA extraction, Spectrophotometry
- Microbiological experience would be an advantage
- Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred