MSAT Scientist Process Development (Downstream)

About MeiraGTx

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 support the MSAT Process Development Group by developing Downstream Process Unit operations for the manufacturing of novel AAV gene therapies.

Major Activities

  • Develop downstream unit operations for the recovery and purification of AAV, including but not limited to chromatography, filtration and TFF.
  • 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 new process technologies, high throughput 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.

Additional Activities

  • 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

  • Knowledge of Engineering principles for scale-up of downstream bioprocess operations.
  • Experience with developing and optimizing chromatography unit operations for the purification of biopharmaceutical products (e.g. MAbs, Virus, Vaccines).
  • Experience with developing and optimizing TFF unit operations for the manufacture of biopharmaceutical products.
  • 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).
  • Experience with running in-process assays such as qPCR, ELISA, HPLC, plate-based spectrometric assays. Understanding of ICH Q2B guidelines desirable.
  • Knowledge of programming, mechanistic process modelling 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.

Candidate background

  • PhD or EngD degree in a relevant Bioprocess/Biochemical/Process Engineering/Biochemistry field and 0-1 year biotech industry experience in process development and process scale up;
  • MS degree in Bioprocess/Biochemical/Process Engineering or Biochemistry or equivalent and >1 year of biotech industry experience in process development and process scale up;
  • BS degree in Bioprocess/Biochemical/Process Engineering or Biochemistry or equivalent and >2 years of biotech industry experience in process development and process scale up;

MSAT Analytical Associate Scientist

About MeiraGTx

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.

Major Activities

  • 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

Additional Activities

  • 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.

Job Responsibilities

  • 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.

Job background

  • MSc degree in chemistry, biochemistry, Analytical science or equivalent.

or

  • BSc degree in chemistry, biochemistry, Analytical science or equivalent.

MSAT Analytical Technician

About MeiraGTx

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 the MSAT Analytical Development team, to support lab stocks, analytical platform support and routine testing. The role will include the organisation of Lab areas and execution of routine analytical testing to support the MSAT development groups using a selection of automated and manual analytical platforms.

Major Activities

  • Performing analytical test methods for analytical and process development samples, including qPCR, ELISA, cell-based analytics and HPLC.
  • Maintain reagent stocks and equipment calibrations to reduce downtime and delays to projects.
  • Design, organise and maintain a routine testing schedule to support sample testing for the development groups.
  • Analysing the data generated experimentally to provide high quality analytical results to study owners.
  • Updating SOPs and Work Instructions for the unit operations being performed to ensure high quality record keeping.
  • Performing routine laboratory tasks.
  • 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.

Additional Activities

  • Support development and implementation of analytical platform methods from the Analytical team into the wider MSAT development group.
  • Provide support for investigations and troubleshooting as required.

Key Performance Indicators

  • Timely and correct completion of experiments according to study protocols and work instructions
  • Good organization and high-quality documentation and record keeping for executed experiments.

Key Job Competencies

  • 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.
  • 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.
  • 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 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.
  • 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.

Job Responsibilities

  • Completion of experiments within provided parameters and timelines.
  • Support the continued development of the MeiraGTx laboratory facilities.
  • Implementation and support of process improvements related to analytical operations.

Job Background

  • Higher level qualification in Biology, Chemistry, Biochemistry, Analytical Science or equivalent.
  • Organized, proactive and motivated with good time management.
  • Interest in laboratory automation for qPCR and ELISA.

MSAT Analytical Development LC-MS Scientist

About MeiraGTx

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 technical expertise to support the implementation and development of a LC-MS platform and associated methodologies. The role will include designing and authoring study plans and the associated reports and includes the execution of experiments described within the study protocols.

Major Activities

  • 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

Additional Activities

  • Support development and implementation of analytical platform methods into the MSAT group.
  • Support technical transfer of methods to GMP core.
  • Ambassador/speaker 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 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.

Job Responsibilities

  • 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.

Job background

  • PhD degree in chemistry, biochemistry, Analytical science or equivalent and 1 year of experience in LCMS Analytical method development.

MSAT Molecular Development Scientist

About MeiraGTx

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 technical execution of projects falling within the Molecular Group remit – this will include Molecular Biology and Cell Engineering.

Major Activities

  • Support the development of the MSAT wet lab facility.
  • Assist senior members of the MSAT team
  • Identify and test opportunities to simplify our business processes and tools.
  • Performing routine cell culture, as well as assisting with Cell Engineering projects.
  • Molecular Biology; Western blot, qPCR, molecular cloning etc.
  • Planning and execution of experiments.

Additional Activities

  • Possibility of attending Cell and Gene Therapy conferences, to increase knowledgebase.
  • Draft SOPs and Work instructions for use within the MSAT team

Key Performance Indicators

  • Completion of experiments within a timely manner, and subsequent preparation of experimental reports

Key Job Competencies

  • 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.
  • 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.
  • Innovation – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
  • Oral Communication – speak 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.
  • Some understanding of compliance, cGMP considerations and GLP.
  • Demonstrated commitment to continuous improvement at the individual, department, and organizational levels.
  • Some knowledge of biotechnology processes/concepts/techniques and engineering principles.
  • Experience of experimental design
  • Some cell culture experience would be desirable.
  • Molecular biology experience, in particular qPCR, Western blot and molecular cloning, would be a benefit.
  • Some experience with statistical tools

Job Responsibilities

  • Completion of experiments according to approved study plans, within the allotted timeframe and budget.
  • Support the development of the MSAT wet lab facility
  • Develop ideas relating to Cell and Vector Engineering.
  • Assist in the performance of routine maintenance and cleaning of the Lab

Job background

  • MS degree in biochemistry or biology or equivalent, and some experience within the biotech industry.
  • BS degree in in biochemistry or biology or equivalent and at least 2 years of biotech industry experience in Research and Development