MSAT Analytical Associate Scientist
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 purpose of the job is to provide support to MSAT Analytical Development Scientists and Analytical Lead, to support the development of projects and analytical platforms. The role will include co-designing and co-authoring study plans and the associated reports and includes the execution of experiments described within the study protocols. After development, technical support will be required to assist in the qualification and validation of these analytical methods.
- Identifying analytical test methods and parameters appropriate to the analyte.
- Planning a design of experiments (DoE) and authoring a study protocol to document the testing required.
- Executing the approved study protocol and recording work performed.
- Analysing the data generated to support the method development.
- Authoring the study report which documents the work performed and conclusions from the study.
- Drafting SOPs and Work instructions for the unit operations that are being developed.
- Identifying and testing opportunities to simplify our business processes and tools
- Drive innovation and challenge conventional assumptions to ensure MeiraGTx stays on the leading edge of manufacturing science and technology
- Develop and implement new technologies/projects which enhance our manufacturing & testing operations (i.e. maximize success rates, reduce recurring discrepancies, increase capacity/productivity, increase levels of safety and/or compliance)
- Performing routine analytical tasks
- Support development and implementation of analytical platform methods into the MSAT group.
- Support technical transfer of methods to GMP core.
- Ambassador for MeiraGTx at key Cell and Gene Therapy conferences
Key Performance Indicators
- Timely completion of experiments according to study protocols
- Correct execution of experiments according to study protocols
- Efficient transfer of analytical methods and techniques to the GMP core
Key Job Competencies
- Analytical mindset- Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs work flows 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.
- 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 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.
- 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.
- Completion of Experiments within provided budget & timelines
- Support the continued development of the MeiraGTx lab facilities
- Implementation and support of Process improvements related to analytics operations.
- MSc degree in chemistry, biochemistry, Analytical science or equivalent.
- BSc degree in chemistry, biochemistry, Analytical science or equivalent.