Material QC 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
- To Manage the Material QC technician(s) and support Good Manufacturing Practice (GMP)-compliant activities for the QC approval incoming materials.
- Review and Approve QC documentation to support QC batch release
- Support QC manager in other acitvties where requested
- Review and approve Quality Control documentation ensureing timely release of GMP compliant materials in accordance with material specifications
- Provide line management to member(s) of the incoming material inspection department to contribute to the overall group objectives
- Coordinate the set-up and scheduling of release testing internally and at external testing houses
- Review and approve test results against specifications to ensure incoming materials are of acceptable quality
- Coordinate and progress OOS invesitgations
- Plan and assign work to the team to achieve the most efficient use of personnel and resources.
- Overseeing the incoming material inspection department to support the seamless supply of materials for the manufacture of drug product
- Ensure all direct reports are fully trained and maintain a high standard of record keeping and documentation so that information is clearly captured, disseminated and reported
- Support the development and implementation of quality control documentation/continuous improvement programmes
- Contribute to the training and development of the team
- Promote appropriate, effective communication within the team, with members of other departments, and with external collaborators
- Contribute to cross departmental activities and providing expert advice and technical input where needed.
- Assure the data integrity of all activities performed
- Ensure area compliance with Quality, Safety and Environmental systems and procedures
- Perform inspection and approval of incoming materials, following SOPs and GMP practices to ensure seamless suppy of material to support aseptic manufacture of ATMP product
- Set up, control and monitor the material inspection programme ensuring materials are suitable for the manufacture of gene therapy products to the required standards
- Phsysical inspection of raw materials. Ensure the warehouse storage environement is acceptable for the materials being inspected (Can be multiple warehouse locations).
- Set up, monitor and Coordinate incoming material testing where required
- Maintain all incoming material documentation meets GMP requirements
- Ensure adequate control of the material status for release or reject
- Comply with meriaGTx procedures including Health and safety and GMP
- To ensure all equipment used is calibrated/maintained and in line with SOP’s
- Identify and report procedureal problems and deviations
- Participate in the planning of duties to ensure the facility is acceptable and customers receive products on time and in full
- Any other duties/projects within the skills and ability of the post holder
- Identify and support method/technology improvement activities and facilitate implementation into the microbiology department
Key Performance Indicators
- HR process Compliance
- Staff turnover rate
- Material release KPIs
- GMP compliance and data integrity
Key Job Competencies
- Experience of working within a GMP manufacturing 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 of techncians for incoming raw mateiral Approval
- Compliance with GMP
- Supervisory and/or management experience of people and/or processes
- Minimum 4 years experience working in a GxP environment
- Experience of quality documentation and batch release
- Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred