Analytical Validation Scientist (9 Months Fixed Term Contract)

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 Scientist is responsible to support 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.

Major Activities

  • To support the development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.
  • Generate validation test protocols, data analysis, and reports in support of the method transfer and validation activities performed ensuring compliance requirements are maintained.
  • Assist external validation activities including supporting method development, proposing validation strategy, and reviewing method documents across CROs for multiple products.
  • Ensure all methods are validated and transferred to QC GMP labs in compliance with regulatory standards and adhere to data integrity requirements.
  • Generate method SOPs are developed and implemented to support all validated methods. Ensure these are current.
  • Ensure timely communication to method transfer progress and plan adherence.
  • Maintain the flow of information to key stakeholders, ensure appropriate communications are passed forward and information folders are maintained with most recent versions/communications.
  • Perform routine assessment of the analytical methods used to assure they are being applied and are operating as expected.
  • Ensure all training is undertaken in a timely manner as required to perform required activities. 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.
  • 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, Protocols, Guidance’s, etc.
  • 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 KPI requirementsDescribe Expectations

Quality control audits

Plan, manage and record training effectively

 

Key Job Competencies

Implement analytical methods for the GMP testing of products and aseptic manufacturing facilities.

Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions and works well in group problem-solving situations.

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; develops realistic action plans.

Professionalism – tactfully approaches others; 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; response 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

Minimally BSc/MSc in Biosciences or Biochemistry with equivalent relevant work experience (2+ years) in the pharmaceutical or other similar regulated industry (biologics).

Demonstrate experience in an analytical development/validation role in the research or pharmaceutical industry.

Preferably experienced with analytical techniques like qPCR, HPLC (RP-HPLC/SEC), ELISA, SDS/Western blot, cell-culture and DNA extraction.

Proficiency in a body of information, mainly, ICH Q2(R1) guidelines will be a plus.

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

Analytical Validation Specialist

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 Specialist 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.

Major Activities

  • The development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.
  • Generate validation test protocols and reports in support of the tech transfer and validation activities performed ensuring compliance requirements are maintained.
  • Support the setup of the QC department for the continuation of the clinical trial material, commercial supply, and stability studies.
  • Ensure all methods are validated and transferred to QC GMP labs in compliance with regulatory standards and adhere to data integrity requirements.
  • Generate method SOPs are developed and implemented to support all validated methods. Ensure these are current.
  • Collaborate with validation, QC, QA, and R&D team as well as with external partners to support internal and external project timelines.
  • Ensure timely communication to method transfer progress and plan adherence.
  • 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.
  • Perform routine assessment of the analytical methods used to assure they are being applied and are operating as expected.
  • Ensure all training is undertaken in a timely manner as required to perform required activities. 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.
  • 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, 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 KPI requirements

Quality control audits

Plan, manage and record training effectively

Key Job Competencies

Implement/qualify/validate analytical methods for the GMP testing of products and aseptic manufacturing facilities.

Problem Solving – Identifies 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/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 – tactfully approaches others; 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; response 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

MSc in Biosciences or Biochemistry with equivalent relevant work experience (3+ years) in the pharmaceutical or other similar regulated industry (i.e. biologics).

Demonstrate significant experience in an analytical development and validation role in the pharmaceutical industry with a strong research background.

Experienced with analytical techniques, example, qPCR, HPLC (RP-HPLC, SEC), ELISA, SDS, cell-culture and DNA extraction, including method development and troubleshooting.

Proficiency in a body of information required for the job e.g knowledge of EU and FDA regulations, ICH guidelines, GMP/GLC/GCP, etc.

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

Material QC 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 incoming materials and support Good Manufacturing Practice (GMP) compliant activities for the QC release of product and incoming materials.

Support QC Materials Team in other acitvties where requested

Major Activities

Materials Department

  • Perform inspection of incoming materials, following SOPs and GMP practices to ensure seamless supply of material to support aseptic manufacture of ATMP product
  • Monitor the material inspection programme ensuring materials are suitable for the manufacture of gene therapy products to the required standards
  • Phsysical inspection of raw materials. Ensure the warehouse storage environment is acceptable for the materials being inspected (Can be multiple warehouse locations)
  • To assist in the Set up, monitor and Coordination of the incoming material testing where required
  • Maintain 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 and report 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
  • Any other duties/projects within the skills and ability of the post holder
  • Contribute to cross departmental activities and providing expert advice and technical input where needed
  • 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

HR process compliance

Material release KPIs

GMP compliance

Data integrity

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

Compliance with GMP

Job Background

  • Minimum 2 years experience working in a GxP environment
  • Experience of quality documentation
  • Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred