QC Analytics Principal Specialist – Gene Therapy
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
This position requires deep understanding of analytical techniques for Gene Therapy analysis and a proven application of cGMP regulations and international guidelines. This knowledge must be combined with clear decision making, pragmatism aligned with quality risk management principles to ensure QC analysis are complaint for clinical and commercial use.
The incumbent will work with the senior management team to assure the company meets development and commercial operational requirements.
- Responsible for leading and providing scientific and technical support to analytical method transfer within the MeiraGTx network and to 3rd party laboratories
- Ensuring analytical methods are fit for purpose and in compliance with applicable regulations and MeiraGTx QMS
- Ensure QC analytical method transfers are planned, effectively tracked, monitored, and achieved in accordance with agreed timelines
- Provide scientific and technical advice for the number of samples (or volume) required for e.g. method qualification, method validation, stability testing etc.
- Establish and maintain effective collaboration and communication with internal peers and stakeholders (e.g. MSAT and Manufacturing) and our Partners
- Company expert to select third party external testing providers and development of analytical testing strategy in line with product /portfolio life cycle
- Represent the company as the QC Gene Therapy expert in analytical matters with our Partners and during regulatory inspections and audits
- Ensure timely communication to method transfer progress and plan adherence
- Ensure timely escalation and resolution of QC issues to site leadership team
- Lead major investigations into issue impacting QC analysis
- Review and approve deviations and change proposals with QC analytical impact
- Authorize and/or prepare scientific and technical documentation as required
- Review & approve GMP documentation e.g. deviation and any change proposals related to analytical issues
- Keeping up to date with latest developments in methods and regulation for ATMP analytics through networks and conferences
- Support supplier/vendor audits as QC Gene Therapy expert
- Support regulatory submissions ensuring they accurately reflect activities and testing performed
- Staying up to date with best practice, regulatory intelligence and sharing that knowledge
- Ensure that own work complies with GMP, Data Integrity & Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP’s, Protocols, etc.
- Ensure own training is undertaken in a timely and GMP compliant manner before the task is undertaken
- Ensure own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved
- Support with all reasonable senior managerial requests and ad-hoc tasks
- Can deputise for the Head of QC
Key Job Competencies
- QC Principal Specialist operates closely with senior management to meet company objectives
- 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; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
- Science based Degree e.g. MSc or PhD
- Substantial experience minimum 10 years’ working in a Pharmaceutical/Biotech QC function within a sterile manufacturing site
- Substantial experience minimum 5 years’ and ‘hands-on’ knowledge of QC analytical technologies and methods within Gene Therapy
- Expert analyst with respect to compliance testing requirements to support Gene Therapy products
- Demonstrated experience in a senior technical role in the Pharmaceutical/Biotech industry
- Proficiency in a body of information required for the job e.g. legislation, guidelines and requirements related to Gene Therapy, QC method qualification and validation, QC processes, equipment and systems, including Computer System e.g. of EU GMP requirements for Advanced Therapy Medicinal Products, EU/FDA GMP guidelines, EU Annex 1, EU Annex 11 & CFR Part 11 and ICH guidelines Q1-Q10
- Demonstrable audit and client facing experience
- Good Collaboration, Communication and Conflict resolution skills
- Good technical writing skills
- Wants to learn and have a natural curiosity to understand systems and processes
- Ability to work in a fast-paced environment essential