MSAT Scientist II/Senior Scientist I (Formulation)

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

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

Candidate background

  • 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.

Major Activities

  • 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.

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

  • 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.

MSAT Process Development Engineer (Graduate)

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

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.

Process Development 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 the development of downstream unit operations for the manufacturing of novel AAV gene therapies, taking novel products from initial process development through to technology transfer to manufacturing.

This vacancy does not have a closing date but applications will be reviewed as they are submitted so interested candidates are encouraged to apply as early as possible.

Candidate background

  • Recent graduate or graduate expecting to receive BSc/BEng or MSc/MEng degree in Chemical/Biochemical Engineering or Biochemistry or equivalent at 2:1 or above.

Major Activities

  • Develop downstream unit operations for the recovery and purification of AAV, including but not limited to chromatography, filtration, TFF and fill/finish.
  • 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.

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.
  • Understanding of how to develop and optimise chromatography unit operations for the purification of biopharmaceutical products (e.g. MAbs, Virus, Vaccines).
  • Understanding of how to develop and optimise 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).
  • Understanding of 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.

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.

USP Development Scientist I

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 USP Process Development department in the design, understanding and tech transfer of AAV Manufacturing processes, including but not limited to suspension cell culture optimization, transient transfection strategies, AAV production scale-up and intensification.

Major Activities

  • Support lab experiments within the USP Development team, aiming to scale-up, intensify and improve the robustness of in-house AAV manufacturing operations at MeiraGTx.
  • Collaborate in the optimization of AAV manufacturing unit operations, including but not limited to seed train, stirred tank bioreactor production, fed batch/perfusion strategies, depth filtration.
  • Operate bioreactors at 250mL to 50L scale to support USP optimization and material generation for DSP development and analytical characterization activities.
  • Participate in the continuous collection of process data, to improve process understanding, ensure process reproducibility and robustness.
  • 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, automation and high throughput development tools, statistical and mechanistic process modelling and DoE techniques.
  • Use process analytical tools, multivariate data analytics software (SAS JMP) and programming tools (Excel VBA, Python) to generate comprehensive and structured datasets and identify optimization opportunities.
  • Present experimental data to various departments at MeiraGTx to support process changes and tech transfer activities.

Additional Activities

  • Maintain cells routinely in shaker flasks.
  • Perform analytical tasks such as qPCR, ddPCR, ELISA, Gyrolab, Picogreen (manually and on automated liquid handling platforms) to support data generation.
  • Participate in routine maintenance of laboratory equipment.
  • Draft SOPs and Work instructions for the unit operations that are being developed.

 Key Performance Indicators

  • Design, schedule and write experimental plans according to changes in business priorities.
  • Timely and accurate completion of experiments according to study protocols.
  • Present data to key stakeholders in a comprehensive and timely manner to support go/no-go decision points.
  • Write Process Development reports to support tech transfer/clinical/commercial filing documentation.

 Key Technical Competencies

  • Knowledge of Engineering principles for scale-up of upstream bioprocess operations.
  • Familiarity with GMP and QbD considerations in a large scale manufacturing environment.
  • Understanding and experience with statistical and modelling software and tools, such as DoE and statistical tests (ANOVA, t-test).
  • Experience with running DNA and protein quantification assays such as qPCR, ELISA, Picogreen.
  • Experience with programming languages such as VBA, Python, SQL or Matlab is desirable.

Key Job Competencies

  • Analytical mindset- Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement 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 Background

  • PhD, EngD or MSc degree in a relevant Bioprocess/Biochemical/Chemical Engineering or Biochemistry field and < 1 year biotech industry experience in process development;
  • BSc degree in Bioprocess/Biochemical/Chemical Engineering or Biochemistry or equivalent and 1-2 years of biotech industry experience in process development

MSAT DNA Method Development Lead

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 lead the development and implementation of DNA based analytical methods within the MSAT Analytical Development Group. This will involve managing the day-to-day activities of Scientists / Technicians and working to develop analytical methods for the manufacture of novel AAV gene therapies.

Major Activities

  • Managing the workload of Scientists / Technicians within the DNA Analytics subgroup of the Analytical Development Team.
  • Take a leading role in scheduling workload, organizing the laboratory, and tracking project timelines.
  • Support technical investigations and liaise with other groups both within Analytical Development and the larger development groups.
  • Present updates to other MSAT teams and senior management.
  • Review study protocols, reports and SOPs and provide guidance to team members.

Additional Activities

  • Identifying and testing opportunities to simplify our business processes and tools.
  • Ambassador for MeiraGTx at key Cell and Gene Therapy conferences.
  • Lead collaborations with third parties to evaluate new analytical equipment / methods related to DNA methods.

Key Performance Indicators

  • Schedule project activities, workload / resources according to changes in business priorities.
  • Ensure timely completion and review of study protocols, study reports and SOPs as well as the timely completion of experiments according to study protocols.
  • Completion of development projects in accordance with deadlines.
  • Present data to key stakeholders in a timely manner to support go/no-go decision points.

Key Technical Competencies

  • Ability to manage multiple employees and projects.
  • Strong understanding of the activities required to develop molecular analytical methods such as qPCR, ddPCR, NGS, and sanger sequencing for viral vectors.
  • Analytical skills, good problem solving technique and statistical analysis skills using software such as Minitab / JMP or similar.
  • Ability to collaborate with team members as well as other departments as part of cross-functional teams.
  • Strong written and oral communication skills.

Key Job Competencies

  • Leadership – able to lead by example in terms of the standards expected of team members. Able to take a holistic approach to prioritization and scheduling that is inline with the goals of the wider organization.
  • Analytical mindset- synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs workflows and procedures.
  • 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.
  • Communication (Oral and Written) – speaks and writes clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.

Candidate background

  • PhD, MSc or BSc in a relevant Genetics/Molecular/DNA/Biochemistry field and at least 5 years industry experience within a technical department.
  • Previous experience in managing / leading projects and or leading a team of Scientists.
  • Experience of project management using tools such as Microsoft Project or Team Gantt to track deadlines and manage priorities.

 

MSAT Process Development Scientist I/II (DSP)

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

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.

Process Development 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 the development of downstream unit operations for the manufacturing of novel AAV gene therapies, taking novel products from initial process development through to tech. transfer.

This role can be filled at either MSAT Process Development Scientist/Engineer I or MSAT Process Development Scientist/Engineer II levels (see below for details).

Candidate background

  • At MSAT Process Development Scientist I:
    • Recent graduate with/graduate expecting to receive BSc/BEng or MSc/MEng degree in Chemical/Biochemical Engineering or Biochemistry or equivalent at 2:1 or above.
  • At MSAT Process Development Scientist II:
    • PhD or EngD degree in a relevant Chemical/Biochemical Engineering or Biochemistry field and 0-2 years of biotech industry experience in process development and process scale up
    • BSc/BEng or MSc/MEng degree in Chemical/Biochemical Engineering or Biochemistry or equivalent and >2 years of biotech industry experience in process development and process scale up

Major Activities

  • Develop downstream unit operations for the recovery and purification of AAV, including but not limited to chromatography, filtration, TFF and fill/finish.
  • 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.

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.
  • Understanding of how to develop and optimise chromatography unit operations for the purification of biopharmaceutical products (e.g. MAbs, Virus, Vaccines).
  • Understanding of how to develop and optimise 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).
  • Understanding of 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.