MSAT Senior Scientist I (Formulation)
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
In Manufacturing Sciences and Technology (MSAT), we strive to break the bottleneck between discovery and clinic by developing faster and better manufacturing processes for the novel gene therapies in our pipeline.
MSAT Scientists/Engineers at MeiraGTx combine a solid understanding of chemical and biological processes with state of the art experimental and computational tools to rapidly develop robust and scalable manufacturing processes. MSAT Scientists/Engineers work within a tight-knit team but are expected to take personal responsibility for producing results and developing their own ideas.
The successful candidate will focus on developing formulations for MeiraGTx’s novel AAV gene therapies. The successful candidate will also be involved in drug product development and developing strategies for improving product stability during drug substance and drug product manufacturing processes. This is a varied and challenging role, and the successful candidate will be expected to question existing practises and implement new or improved work flows and processes.
This role can be filled at either MSAT Scientist II or MSAT Senior Scientist I levels (see below for details).
- At MSAT Scientist II:
- PhD/EngD/PharmD degree in a relevant Chemical/Biochemical Engineering or Biochemistry or Pharmaceutical Sciences field and 0-2 years of biotech industry experience in formulation/downstream process/drug product development.
- BSc/BEng or MSc/MEng degree in Chemical/Biochemical Engineering or Biochemistry or Pharmaceutical Sciences or equivalent and >2 years of biotech industry experience in formulation/downstream process/drug product development.
- At MSAT Senior Scientist I:
- PhD/EngD/PharmD degree in a relevant Chemical/Biochemical Engineering or Biochemistry or Pharmaceutical Sciences field and >2 years of biotech industry experience in formulation/downstream process/drug product development.
- BSc/BEng or MSc/MEng degree in Chemical/Biochemical Engineering or Biochemistry or Pharmaceutical Sciences or equivalent and >5 years of biotech industry experience in formulation/downstream process/drug product development.
- Develop formulations for AAV based gene therapies.
- Perform stability studies to evaluate drug product and in-process intermediate stability.
- Develop strategies for improving product stability during the drug substance and drug product manufacturing processes.
- Develop drug product manufacturing processes.
- Evaluate drug product container and device compatibility.
- Scale up and tech transfer lab scale unit operations to in-house GMP production facility.
- Build continuous understanding and knowledge of unit operations, to ensure process reproducibility and robustness.
- Support Manufacturing operations with implementing new processes and troubleshooting activities.
- Drive innovation and challenge conventional assumptions to ensure MeiraGTx stays on the leading edge of manufacturing science and technology, such as the use of new process technologies, high throughput automated development tools, statistical and mechanistic process modelling and DoE tools.
- Use appropriate process analytical tools to generate comprehensive and structured data, improve process understanding and identify optimization opportunities.
- Identifying and testing opportunities to simplify our business processes and tools.
- Ambassador for MeiraGTx at key Cell and Gene Therapy conferences.
- Draft SOPs and Work instructions for the unit operations that are being developed.
Key Performance Indicators
- Adapt, schedule and write experimental plans according to changes in business priorities.
- Timely completion of experiments according to study protocols.
- Present data to key stakeholders in a timely manner to support go/no-go decision points.
- Completion of reports and supporting clinical/commercial filing documentation.
Key Technical Competencies
- An understanding of the techniques used to characterise the biochemical and biophysical properties of AAV products such as SEC-HPLC, DLS, SLS and AUC.
- Knowledge of the mechanisms that cause product instability.
- An understanding of the drug substance and drug product manufacturing process used for biopharmaceutical products (e.g. MAbs, Virus, Vaccines).
- Knowledge of the approaches used for developing formulations for different dose forms, e.g., liquid, frozen, lyophilised.
- An understanding of the design and execution of stability studies.
- An understanding of drug product development including the evaluation of drug product vessel/device compatibility is desirable but not essential.
- Understanding of GMP and QbD considerations in a large scale manufacturing environment.
- Understanding and experience with statistical and modelling software and tools, such as DoE, multivariate analysis, statistical tests (ANOVA, t-test).
- Understanding of in-process assays such as qPCR, ELISA, HPLC, plate-based spectrometric assays. Understanding of ICH Q2B guidelines desirable.
- An understanding of molecular modelling and how might be used to investigate product instability and influence formulation development is desirable but not essential.
- Knowledge of programming and automated data handling are desirable but not essential.
Key Job Competencies
- Analytical mindset- 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.
- 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.
- Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
- Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken
- Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state