Senior QC Microbiology Analyst
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 Senior QC Analyst position works within the Quality Control team. The QC Analyst is responsible for the microbiology environment monitoring sampling of the facility, incubation and analysis of microbiology samples, QC validation and testing and general facility audit readiness.
- To lead and execute technical projects for the MeiraGTx QC department Ireland (Shannon) site.
- Accountable for the delivery of business-critical microbiological projects including assisting with setting up the Microbiology laboratory in Shannon and establishment of lean laboratories.
- Responsible for technical oversight and management of microbiological requirements and act as technical expert for Microbiology as required.
- Will work with the QC team and key stakeholders across the business to ensure the microbiological testing capabilities and improvement plans are implemented on-time, on-budget and to the required quality standards to ensure the company meets the development and commercial operational requirements.
- Performs environmental monitoring of the MeiraGTx aseptic manufacturing facility.
- Ensures all testing is completed as per Environmental Monitoring programme.
- Adheres to aseptic technique when working in controlled facilities as well as laboratories.
- Performs analysis of the environmental monitoring samples.
- Updates EM results database.
- Records and reports out of specification results and implements corrective actions as applicable.
- Maintains QC facilities to meet GMP requirements, conducts necessary checks to support any health authority, customer/stakeholders site visits.
- Ensure the laboratory paperwork and operations are fully GMP compliant.
- Performs QC testing of materials and products as required.
- Operates and maintains laboratory equipment, ensuring all equipment is calibrated and suitable for use as applicable.
- Handles or disposes of hazardous materials safely and in accordance with procedures.
- Supports maintaining the Quality Management System and control of documents, ensuring the data integrity of all data produced.
- Supports with all reasonable managerial requests and ad-hoc tasks.
- Works closely and collaborates with the Manufacturing, Engineering, QA and Supply Chain teams.
- Ensure own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g., SOP’s, BMR’s, Protocols, Guidance’s, etc.
- Ensure own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
- Ensure Project KPI’s, plans, targets and objectives are effectively monitored and achieved, and performance levels highlighted.
- Responsible for leading and providing microbiological insight and process implementation support to transformational projects.
- Ensuring all key stakeholders across the business are aligned and resources engaged to ensure successful completion of the microbiological projects.
- Ensure projects are planned, effectively tracked, monitored, and delivered in accordance with the agreed requirements.
- Assist in selecting and managing external testing suppliers
- Writing/reviewing and approving technical documentation as required
- Establish and maintain effective collaboration and communication with internal peers and stakeholders (e.g., Manufacturing, Engineering and Facilities).
- Become the site expert on microbiology specific projects and share the knowledge with stakeholders and partners.
- Ensure timely communication and escalation of issues and concerns to senior management when necessary.
Key Performance Indicators
- All testing performed meets KPI requirements.
- Environmental monitoring requirements for the facility are achieved to ensure manufacturing conditions meet aseptic manufacturing standards are met.
- Environmental monitoring OOS and OOT are investigated within established timelines.
- Ensure all training is undertaken in a timely manner as required for each activity.
- Internal QC audits performed.
- Quality Events are dealt with in a timely manner.
- Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs workflows and procedures
- Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
- Change Management – Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
- Technical Leadership – exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others with expert knowledge; accepts feedback from others; gives appropriate recognition to others.
- Cost Consciousness – works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.
- 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; organizes or schedules other people and their tasks; develops realistic action plans.
- 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.
- Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness and promoting data integrity.
- Innovation – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
- Oral Communication – speaks clearly and persuasively in positive or negative situations; 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.
BSc in Microbiology or equivalent relevant work experience in pharmaceutical or other similar regulated industry (i.e., biologics or medical devices)
Minimum 5 years’ experience of Microbiology in the Pharmaceutical/Biotech sector. Experience of working in aseptic manufacturing highly desirable.
Preferred knowledge of GMP/GLP regulations, FDA regulations etc
Ability to work in a fast-paced environment and demonstrate the flexibility to adapt/change priorities is essential.