MSAT 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.

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

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.
  • 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

Project Manager – MSAT

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 key purpose of this job is to develop, maintain and improve activities to enable a seamless and time efficient transition of preclinical programs into clinical studies. This role should aim to achieve clear alignment of activities within internal functional groups and with stakeholders at multiple seniority levels inside and outside of the company.

Major Activities

  • Manage the timelines and coordination from pre-clinical research programmes into MSAT using standardized approaches from the receiving unit.
  • Manage the timelines and coordination from MSAT programs to GMP programs using standardized approaches from the sending unit.
  • Pre-empt and identify opportunities/risks to the MSAT pipeline and resource utilisation.
  • Manage communication for third party testing and development labs for MSAT programs.
  • Maintain project dashboards per therapeutic product
  • Maintain alignment of ongoing and new programs with cross functional teams.
  • Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
  • Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken
  • Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state

 Key Performance Indicators

  • 4 new product introductions from pre-clinical to GMP per annum
  • Up to date visualization of development timelines and dependencies
  • Optimized systems for transferring and tracking information and technology between parties

Key Job Competencies

  • Experience with Project management methodologies (PMP/PRINCE2/Agile/SCRUM)
  • Experience with project Gantt software
  • Visualization of timelines and dependencies to different stakeholders
  • Experience with AAV manufacturing workflows
  • Experience with AAV analytics workflows
  • 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.
  • 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.
  • 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.
  • Demonstrated commitment to continuous improvement at the individual, department, and organizational levels.
  • Experience with experimental design, with an understanding of process validation.

 Job Responsibilities

  • Visualization of timelines per program and budget for external initiatives.
  • Continuous optimization of systems and methodologies to manage product transition from pre-clinical to clinical manufacturing and release.
  • Communication with global internal and external parties.

Job background

  • MSc degree in biological discipline or equivalent is desired.
  • BSc degree in biological discipline or equivalent and 2 years of academic/ biotech industry.
  • Accredited PM qualification (PRINCE2/AgilePM/PMP) desirable but not essential.

MSAT Molecular Development Scientist Grade I/II

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

  • Identify and test opportunities to simplify our business processes and tools.
  • Develop and manage projects independently.
  • Assist with Cell and Vector Engineering projects.
  • Molecular Biology; Western blot, qPCR, molecular cloning etc.
  • Planning and execution of experiments.
  • 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

Additional Activities

  • Attend 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 their 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 organisational levels.
  • Some knowledge of biotechnology processes/concepts/techniques and engineering principles.
  • A good understanding of experimental design
  • Tissue culture
  • Some Cell Engineering experience would be an advantage.
  • 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.
  • Develop ideas relating to Cell and Vector Engineering.
  • Assist in the performance of routine maintenance and cleaning of the laboratory

Job background

  • Bachelors or MSc degree in Biology or equivalent, and some experience within the biotech industry.

MSAT Protein Analytics lead (Analytical Development)

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 Protein 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 protein analytics subgroup of the Analytical Development Team.
  • Take a leading role in scheduling workload, organizing the laboratory, and tracking project timelines.
  • Lead technical investigations and liaise with other groups both within Analytical Development (i.e. Molecular Analytics) and outside of Analytical Development (i.e. Upstream Processing, Downstream Processing, Pre-Clinical and operations groups).
  • Present updates to other MSAT teams and senior management. This includes deputizing for he Analytical Development Lead when required.
  • Review study protocols, reports and SOPs and provide guidance to junior team members.
  • 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

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.
  • Lead collaborations with third parties to evaluate new analytical equipment / 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 protein analytical methods such as ELISA, HPLC, LC-MS, CE etc.
  • Understanding of ICH Q2B guidelines or industry equivalent.
  • 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 junior 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, or MSc in a relevant Chemistry/Biochemistry/Analytical science 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 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
  • 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

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 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 molecular (DNA) 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.
  • Lead technical investigations and liaise with other groups both within Analytical Development (i.e. Protein Analytics) and outside of Analytical Development (i.e. Upstream Processing, Downstream Processing, Pre-Clinical and operations groups).
  • Present updates to other MSAT teams and senior management. This includes deputizing for the Analytical Development Lead when required.
  • Review study protocols, reports and SOPs and provide guidance to junior team members.
  • 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

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.
  • Lead collaborations with third parties to evaluate new analytical equipment / 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 titering for viral vectors and sequencing technology
  • Understanding of ICH Q2B guidelines or industry equivalent.
  • 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 junior 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, or MSc 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.