QC Method Validation Manager

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 Analytical Validation manager is responsible for the validation and technology transfer of novel and established test methods for the analysis of gene therapy products and associated materials used for manufacturing the EU and FDA GMP requirements. The role involves life cycle management of assays, equipment and materials/products.

Major Activities

  • Lead the development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.
  • Serve as the subject matter expert for lifecycle management of analytical assays, equipment and materials including inprocess samples and finished products.
  • Generate qualification/validation projects and associated documentation in support of the analytical activities performed ensuring compliance requirements are maintained.
  • Support the set up of the QC department for the continuation of the analytical testing for clinical trial materials, commercial supply and stability studies.
  • Ensure all methods are validated and performed in the QC GMP labs in compliance to regulatory standards and adheres to data integrity requirements.
  • Generate master QCAR documents and implement to support all analytical methods. Ensure these are current.
  • Develop and maintain stability programs for materials and products
  • Responsible for the project management of test method implementation to required timescales to ensure seamless launch of new products.
  • Maintain the flow of information to key stakeholders, ensure appropriate communications are passed forward and information folders are maintained with most recent versions/communications.
  • Ensure the development and rollout of training on new technology/methodology introduced to the facility.
  • Perform routine assessment of the analytical methods used to ensure they are being applied and are operating as expected.
  • Ensure all training is undertaken in a timely manner as required to perform required activies. Support any training activities of other employees where required.
  • Support with maintaining with Quality Management System and controlling of documents and ensuring the data integrity of all data produced.
  • Support with all reasonable managerial requests and ad-hoc tasks.
  • Ensure area compliance with Quality, Safety and Environmental systems and procedures
  • Comply with MeiraGTx procedures including Health and Safety and GMP
  • Ensure own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP’s, BMR’s, Protocols, Guidance’s, etc.
  • Ensure own training is undertaken in a timely and GMP compliant manner before the task is undertaken
  • Ensure own KPI’s, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines

Key Performance Indicators

Implementation of test methods to meet site timelines and KPI requirements

Implementation of stability programs to meet site timelines and KPI requirements

Quality control audits

Key Job Competencies

  • Implement/qualify/validate analytical methods for the GMP testing of products and aspectic manufacturing facilities – understanding of regulatory requirements for analytics and stability for ATMPList key competencies to fulfil role
  • Problem SolvingIdentifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions and works well in group problem solving situations.
  • Leadership – exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
  • 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/Organising – 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.
  • Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
  • 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

Lead a team of scientist and analysts to deliver the function on time and within budget

Job Background

Degree in Human Health or Sciences equivalent relevant work experience in the pharmaceutical or other similar regulated industry (i.e. biologics).

Demonstrate significant experience in a analytical development and validation role in the pharmaceutical or other regulated industry.

Proficiency in a body of information required for the job e.g knowledge of EU and FDA regulations, GMP/GLC/GCP, Lean Manufacturing, Six-Sigma, etc.

Proficiency in IT, Microsoft Office software (Word, Excel, Powerpoint) preferred.

QC Analytics Principal Specialist – Gene Therapy

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

This position requires deep understanding of analytical techniques for Gene Therapy analysis and a proven application of cGMP regulations and international guidelines. This knowledge must be combined with clear decision making, pragmatism aligned with quality risk management principles to ensure QC analysis are complaint for clinical and commercial use.

The incumbent will work with the senior management team to assure the company meets development and commercial operational requirements.

Key Responsibilities

  • Responsible for leading and providing scientific and technical support to analytical method transfer within the MeiraGTx network and to 3rd party laboratories
  • Ensuring analytical methods are fit for purpose and in compliance with applicable regulations and MeiraGTx QMS
  • Ensure QC analytical method transfers are planned, effectively tracked, monitored, and achieved in accordance with agreed timelines
  • Provide scientific and technical advice for the number of samples (or volume) required for e.g. method qualification, method validation, stability testing etc.
  • Establish and maintain effective collaboration and communication with internal peers and stakeholders (e.g. MSAT and Manufacturing) and our Partners
  • Company expert to select third party external testing providers and development of analytical testing strategy in line with product /portfolio life cycle
  • Represent the company as the QC Gene Therapy expert in analytical matters with our Partners and during regulatory inspections and audits
  • Ensure timely communication to method transfer progress and plan adherence
  • Ensure timely escalation and resolution of QC issues to site leadership team
  • Lead major investigations into issue impacting QC analysis
  • Review and approve deviations and change proposals with QC analytical impact
  • Authorize and/or prepare scientific and technical documentation as required
  • Review & approve GMP documentation e.g. deviation and any change proposals related to analytical issues
  • Keeping up to date with latest developments in methods and regulation for ATMP analytics through networks and conferences
  • Support supplier/vendor audits as QC Gene Therapy expert
  • Support regulatory submissions ensuring they accurately reflect activities and testing performed
  • Staying up to date with best practice, regulatory intelligence and sharing that knowledge
  • Ensure that own work complies with GMP, Data Integrity & Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP’s, Protocols, etc.
  • Ensure own training is undertaken in a timely and GMP compliant manner before the task is undertaken
  • Ensure own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved
  • Support with all reasonable senior managerial requests and ad-hoc tasks
  • Can deputise for the Head of QC

Key Job Competencies

  • QC Principal Specialist operates closely with senior management to meet company objectives
  • Analytical – 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.
  • Technical Leadership – exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others with expert knowledge; accepts feedback from others; gives appropriate recognition to others.
  • 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.
  • Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness and promoting data integrity.
  • 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; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

Job background

  • Science based Degree e.g. MSc or PhD
  • Substantial experience minimum 10 years’ working in a Pharmaceutical/Biotech QC function within a sterile manufacturing site
  • Substantial experience minimum 5 years’ and ‘hands-on’ knowledge of QC analytical technologies and methods within Gene Therapy
  • Expert analyst with respect to compliance testing requirements to support Gene Therapy products
  • Demonstrated experience in a senior technical role in the Pharmaceutical/Biotech industry
  • Proficiency in a body of information required for the job e.g. legislation, guidelines and requirements related to Gene Therapy, QC method qualification and validation, QC processes, equipment and systems, including Computer System e.g. of EU GMP requirements for Advanced Therapy Medicinal Products, EU/FDA GMP guidelines, EU Annex 1, EU Annex 11 & CFR Part 11 and ICH guidelines Q1-Q10
  • Demonstrable audit and client facing experience
  • Good Collaboration, Communication and Conflict resolution skills
  • Good technical writing skills
  • Wants to learn and have a natural curiosity to understand systems and processes
  • Ability to work in a fast-paced environment essential

 

Quality Control – Analytical Stability Coordinator

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 Quality Control – Analytical Stability Coordinator, will be responsible for managing and coordinating MeiraGTx Quality Control stability programmes for the manufactured gene therapy products.

Key Responsibilities

  • Set up, manage and coordinate stability programmes within Quality Control.
  • Ensure timely completion of stability timepoints within the necessary testing windows.
  • Draft and review stability protocols and reports.
  • Perform a QC review of stability associated documentation (i.e., analytical methods and forms).
  • Track and trend stability data and highlight any observable trends.
  • Identify, raise, and investigate any out of specification/ trend and or aberrant results.
  • Collaborate with QC Analytical team lead to ensure the necessary resource is allocated to each stability timepoint.
  • Comply with MeiraGTx procedures including Health and Safety and GMP.
  • Ensure the necessary stability samples are shipped to the correct external test sites.
  • Oversee external contractors and the smooth transition of samples, analysis, and data.
  • Liaise with external contractors to review and approve externally generated data.

Key Performance Indicators

  • Timely completion of stability timepoints.
  • External analysis is scheduled and performed within testing windows.
  • Timely completion of Quality Events/ Documentation.

Key Employee Competencies

  • A high Level of attention to detail.
  • Problem Solving – Identifies and resolves problems in a timely manner; able to gather and analyse information; develops alternative solutions; works well in group problem solving situations.
  • Leadership – exhibits confidence in self and others when leading a team of people and managing processes.
  • 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.
  • 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 – meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
  • Oral Communication – speaks clearly; 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.

Material QC Senior 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

To manage the incoming materials qualification and release programme and support Good Manufacturing Practice (GMP) compliant activities for the QC release of product and incoming materials.

Support QC Materials Team in other activities where requested

Major Activities

Materials department

  • Set-up and monitor the material inspection programme ensuring materials are suitably qualified for the manufacture of gene therapy products
  • Provide expert technical input where needed and support on quality records associated with raw materials testing e.g. deviations, change controls and CAPA
  • Key contact for technical support for new material requirements
  • Implementation of in-house ID (IR / Raman) testing
  • Implementation of in-house raw materials testing in Shannon
  • Ownership and responsibility for maintenance and review of materials SOP’s, equipment and Test methods
  • Work closely with external testing houses and review the results for technical and quality compliance
  • Perform trending of incoming material qualification data
  • Works closely and collaboratively with warehouse, supply chain and QA teams to ensure completion of activities to support incoming material release
  • Ensure all incoming material documentation meets GMP requirements
  • Ensure adequate control of the material status for release or Reject
  • Comply with MeiraGTx procedures including Health and safety and GMP
  • Identify, report and investigate procedural problems and deviations
  • Participate in the planning of duties to ensure the facility is acceptable and customers receive products on time and in full
  • Supports with all reasonable managerial requests and ad-hoc tasks
  • Contribute to the training and development of others
  • Participate in the planning of duties to ensure the facility is acceptable and customers receive products on time and in full
  • To assist in the generation of the departmental KPI’s as when required

Key Performance Indicators

Material release KPIs are met

All training is completed on-time

Quality KPI’s are met

All work meets GMP and Data Integrity requirements

Internal QC audits performed

Key Job Competencies

  • Experience of working within a GMP manufacturing environment.
  • Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness
  • A high Level of attention to detail
  • Problem Solving – Identifies and resolves problems in a timely manner; able to gather information; develops alternative solutions; works well in group problem solving situations
  • 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.
  • 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 – meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas
  • Oral Communication – speaks clearly; 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
  • Physical & mental requirements – occasional lifting; the noise level in the work environment is usually moderate

Job Responsibilities

  • 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

Job Background

  • BSC in Chemistry/Biology or equivalent relevant work experience in pharmaceutical or other similar regulated industry (i.e. biologics or medical devices).
  • Knowledge of GMP/GLP regulations, FDA regulations and a minimum of 5 years experience in a GxP environment
  • Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred