Automation Engineer – FTC 12 months

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

MeiraGTX is looking for a bright, ambitious Automation Engineerwho can  quickly build up  our internal expertise in our current “Operational Technology” systems, to improve system robustness and reduce our dependency on specialist suppliers..

They will be responsible for designing, developing, implementing, and maintaining industrial computerized process control and process monitoring systems (SCADA, PLC and HMIs) in a biopharmaceutical manufacturing cGMP environment for MeiraGTx in both London and Ireland.

They will enhance reliability and recommend and implement practical improvements to MeiraGTx’s control systems (including SCADA, PLCs, EMS, BMS) to enhance reliability and recommend and implement practical improvements.

As such they will relish the range of accountability from hands on trouble shooting on the front-line to developing strategic plans for implementation in line with the development of our two GMP manufacturing sites and the growth of our later stage clinical pipeline.

They will write and/or review user requirements, functional requirement specifications, automation equipment qualification protocols, enterprise or system interfaces, process development reports, and provide technical assessments, rationales and approval for engineering and process changes to meet regulatory requirements. You will work with the Process Development, Manufacturing and Quality teams to design and implement automation to MeiraGTx’s Gene Therapy manufacturing platforms as these emerge from Process Development and are transferred and scaled for Late Stage Clinical and commercial manufacturing. processes you will support automated equipment qualification and draft documentation for regulatory filings to advance MeiraGTx’s product portfolio.

Major Activities

  • Translate business, technical, and regulatory requirements into systems-level solutions during development and deployment of automated processing technologies
  • Manage technical work streams with cross-functional stakeholders throughout entire project lifecycle, from concept to implementation
  • Responsible for automation support on Vendor Packaged Equipment, Building Management Systems, and Environmental Monitoring System, including monitoring, maintaining, trouble shooting and investigating control system hardware, wiring, and instrumentation.
  • Develop, review and/or approve Preventive Maintenance Plans, Standard Operating Procedures, IQ/OQs, commissioning protocols, user requirement specifications, acceptance test plans, Functional Specifications, Design Specifications, and drawings and diagrams.
  • Work with site Quality and Computer System Validation personnel to ensure automation and control system GMP compliance.
  • Implement and complete change controls, CAPAs, and Deviations for automated GMP systems and equipment.
  • Proactively search for and implement innovative solutions to improve system performance, reliability, and compliance.
  • Support training efforts for new equipment installations

Job Background

  • Bachelor’s degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines with minimum 2 to 5 years’ experience, supporting or developing automated systems.
  • Strong understanding of automation standards and architecture addressing batch process control, such as S88, and related automation systems, including process control systems, manufacturing execution systems and process data historians
  • Experience in pharmaceutical/ biopharmaceutical drug substance manufacturing environments and processes.
  • Proven programming and maintenance experience with DCS, PLCs and Software applications, ideally across a number of industrial platforms
  • Experience with supporting and maintaining automation and control system infrastructure, including DCS, PLCs, remote I/O panels, BMS equipment, wiring and cabling systems, as well as proprietary equipment controllers and control systems
  • Experience with various data communication protocols and architectures, including ControlNet, Ethernet I/P, Modbus, BACnet and/or Profibus
  • Works and communicates well in a multi-discipline team structure
  • Demonstrates skills in requirements gathering, design, configuration, integration, and implementation of process control solutions for the manufacturing industry including batch software, PLC based control systems, HMI packages, building management systems, SCADA systems, and PC networking technology
  • Familiarity with FDA GMPs and FDA regulations relating to biologic and drug products
  • Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11

Technical Transfer Specialist – Process Validation

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 establish and lead the processes required to carry out validation of manufacturing processes and methods in line with ICHQ8-10.

To support the organisation and processes for project management and technical support in product lifecycle management activities (BLA, Product Launch).

Major Activities 

  • Responsible for establishing and leading process validation of processes in line with ICHQ8-10.
  • Project leadership/management and formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, launch and subsequent lifecycle management.
  • Develop technical subject matter expertise in the technical support team and wider manufacturing operations.
  • Lead and/or provide technical support using established problem solving techniques for investigations into quality events. Provide technical recommendations, co-ordinate and execute CAPA’s.
  • Management of change controls; providing impact assessments as a technical functional, coordinating input and support from development if required. Lead/support and/or coordinate the action plans.
  • 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

Main Team Activities

  • Provision of technical expertise for planned activities and unplanned business issues.
  • Co-ordinate and participate in cross functional teams to complete root cause analysis using established problem solving techniques. Reporting and presenting findings, outcomes and recommendations.
  • Manage and/or support process and analytical transfers for any transfers from development, CMOs and partners into MeiraGTx manufacturing/testing facilities
  • Leading the development and continuous improvement of manufacturing and analytical techniques for life cycle management in accordance with GxP, regulatory requirements and company policies and procedures.
  • Author/review/execution process validation and performance qualification protocols for manufacturing processes.
  • Author/review of relevant CMC sections of regulatory dossiers and support regulatory compliance initiatives including gap analysis, responding to RFIs, regulatory incidents and post approval commitments.
  • Contribute to the technical strategy for the product portfolio.

Relationships

  • Reports to Head of Technology Transfer.
  • Works cross functionally as a strong leader and establish effective partnerships with functional leads in development, quality and manufacturing.
  • Acts as a point of contact for the technical information in manufacturing and methods with clear understanding of the strengths of the developing SME network and how to access and use it.
  • To work closely with the selected suppliers of raw materials and equipment during the development, tech transfer and implementation of new products, continuing through the life cycle management of existing products.
  • Management and coordination of expert external resources.

 Key Job Competencies

  • 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.
  • 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.
  • Commercial acumen– gets involved in strategic decision-making within the business as an influencer. Able to understand company finances, resourcing and the ultimate aims of the business
  • 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.
  • Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
  • 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

  • Scientific Degree or equivalent, preferably with a higher qualification in a discipline related to bio-pharmaceutical sciences.
  • Extensive industrial experience in Pharma/Bio within a GMP regulated environment.
  • Experience of transferring pharmaceutical products from Development into a GMP manufacturing environment, successfully gaining approval and launching new products commercially.
  • Demonstrated interpersonal skills with ability to work cross-functionally both with internal and external partners.
  • Excellent communication skills.
  • Knowledge of the Regulatory compliance requirements within Europe and the USA.
  • Demonstrated experience in the management of root cause analysis investigations utilising Lean/Six Sigma tools.
  • Ability to manage, multiple, cross functional projects to deliver against key project milestones and deadlines.
  • Experience of managing workload of small teams to meet deadlines.
  • Excellent verbal and written communication skills, in English.
  • Ability to present effectively to groups.
  • Excellent influencing skills and ability to establish effective working relationships with personnel at all levels.
  • Thorough working knowledge of ICH guidelines and current Good Manufacturing Practices.

Bioprocessing Scientist – x6

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 main purpose of the Bioprocessing Scientist is to support Good Manufacturing Practice (GMP)-compliant activities for the production of sterile gene therapy Products.

Major Activities

  • Perform production processes, following SOPs and GMP practices to manufacture required products
  • Proficient in the use of aseptic manufacturing techniques to assure the manufacture of intermediate sterile products
  • Operate to appropriate GMP practices within clean room environment to assure continued compliance within those areas
  • Carrying out the day-to-day monitoring of the GMP facility to ensure that the facility operates in a compliant and safe manner to allow the production of gene therapy products at the required
  • Perform routine cleaning of the manufacturing facility
  • Review and update process documents as required
  • Perform the environmental monitoring of the manufacturing facility
  • Ensure that the MeiraGTx manufacturing facility and storage areas are maintained in a fit-for-purpose state
  • Conduct regular stock checks and assist in the maintenance of the stock inventory
  • Assist in stock control including ordering against defined specifications and receipt of materials, appropriate storage of starting biological products, (Quality Control QC) approval and release of materials for use
  • Comply with MeiraGTx procedures including Health and safety and GMP
  • To ensure all equipment used is calibrated/maintained and in line with SOP’s
  • Recognize and report procedural problems and deviations
  • Participate in the planning of duties to ensure customers receive products on time and in
  • Any other duties/projects as are responsible and within the skills and ability of the post holder
  • If required, support technology transfer activities as new processes are transferred into manufacturing

Key Performance Indicators

Aseptic technique qualification GMP compliance

Contamination free GMP Batch manufacture Data integrity

Key Job Competencies

Aseptic processing – Operates to appropriate manufacturing practices to avoid cross contamination and sterile processing

Problem Solving – Identifies and resolves problems in a timely manner; able to gather and analyze information; develops alternative solutions; works well in group problem solving situations

Leadership – exhibits confidence in self and 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

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.

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; occasionally exposed to fumes or airborne particles; the noise level in the work environment is usually moderate.

Job Responsibilities

Compliance with GMP

Job Background

Certificate or Degree in Bioprocessing or Degree in a relevant scientific discipline with practical laboratory elements (or equivalent) or relevant previous experience.

Experience in pharmaceutical product manufacture (preference for biologics and aseptic manufacture) Good understanding of GMP

Practical experience of sample preparation and analysis Need to be numerate

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

Training for this role may be based in London

Procurement 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.

Key Job Purpose

Procurement of services, capex, direct & indirect materials. Working closely with key stakeholders in each of the departments.

Management of key suppliers and responsible for delivery of procurement projects to agreed timelines by effectively leading negotiations and supporting the purchasing strategies which meet budgetary and other operational requirements of the company, in compliance with GMP and GDP.

Major Responsibilities

  • Ability to drive results, ensuring continuity of materials and services and achieving stretch targets. Develop strong, strategic relationships with critical suppliers.
  • Manage commodity prices, source new suppliers and negotiate favourable terms. Perform cost analysis and set appropriate benchmarks.
  • Identify cost saving opportunities and manage through to implementation. Manage risks and opportunities within the supply chain.
  • Build collaborative partnerships with both internal stakeholders and external vendors.
  • Lead and support successful tenders, tender evaluation, negotiations and contract awards.
  • Support the supplier approval process where appropriate to ensure the right suppliers are selected for provision of existing and new goods and services.
  • Identify priority areas for improvement based on material criticality, value and volume to reduce supply risks and improve material cost.
  • Support the implementation/execution of proposals, strategies, initiatives, contracts & programs for the categories and suppliers.
  • Participate and support cross functional working groups that deliver strategic guidance and governance across categories.
  • Ensuring procurement master data accuracy in the Oracle (NetSuite) ERP system for material price and suppliers.

Key Performance Indicators

  • Influence internal stakeholders and business unit associated with categories and suppliers to adopt and comply with sourcing, procurement, frameworks and practices developed and implemented.
  • Implement a customer service mindset/framework with internal stakeholders to increase the likelihood of adoption and compliance of procurement practices.
  • Support and drive priority areas for improvement based on material criticality, value and volume to reduce supply risks and improve material cost.
  • Work with QA to ensure that existing and new suppliers are, and remain fully compliant with GMP and GDP.
  • Deliver first class procurement support to internal stakeholders, securing supply of critical direct and indirect materials to support company growth plans.

Key Job Competencies

  • 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.
  • Commercial acumen– gets involved in the support of strategic decision-making within the business as an influencer. Able to understand company finances, resourcing and the ultimate aims of the business.
  • 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.
  • 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

The successful candidate will have: 

  • Experience working within a fast-paced manufacturing environment. Exposure to quality and regulatory systems GMP & GDP.
  • Strong analytical and project management skills are required.
  • Demonstrated experience across a range of services, capital equipment, raw materials and finished pharmaceutical products.
  • Experience in purchasing biological starting materials or other specialist technical raw materials will be a distinct advantage.
  • Experience of ERP/MRP system usage a distinct advantage. Experience of commodity purchasing.
  • Strong communications skills with a consultative approach to influence and negotiate with Stakeholders across the business.
  • Fluent in English, another language would be desirable but not essential. Ideal Degree or working towards MCIPS qualification.

Process Engineer

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 role is required due to MeiraGTx having set up its internal Manufacturing Facility for the manufacture of Advanced Therapies (Gene Therapy viral vectors) in Shannon. The facility is planned to manufacture Phase 3 and and commercial supply for its in-house programmes. The facility requires a Process / Project engineer to assist the engineering manager with the co-ordination of the day to day site operations, performance improvements, to the range of utility services and manufacturing equipment across the site. Support capital and Tech Transfer projects across the site.

This is a fast track programme, therefore the role requires the ability to be flexible and covers a very broad remit.

Major Activities

  • Support Capital project design and review
  • Support Product technical transfer and Process qualification activities
  • Oversee service contractor activities for maintenance, Calibrations, Comissioning and Qualification
  • Assist with the continuous development and implementation of the internal and external Engineering sopecifications and procedures.
  • Carry out PPM and reactive maintenance as
  • Maintain all current statutory, regulatory and company safety and quality
  • Assist with the implementation, maintenance and measurement of a framework for compliance and ongoing improvement in quality performance and right first time culture within the facilities and engineering
  • area. This will be in accordance with statutory, regulatory and company standards, procedures and systems regarding relevant cGMP, Quality Systems and Health and Safety in the workplace.
  • Ensure the availability and reliability of building utilities, services and manufacturing equipment for the operational areas, in order that they can achieve the plans to satisfy customer
  • Develop and manage strong relationships across teams to remove barriers and time
  • Assist with the identification and implementation of technology based and working practice solutions designed to reduce the overall cost per unit
  • Assist with the development and maintenance of the engineering budget and and critical spares

Key Performance Indicators

  • Improving Key Performance Indicator’s for building utilities services; equipment availability and performance; safe and quality compliant facility
  • Supporting project deliverables delivery on
  • Development of an asset care strategy and growing profitability through reducing the cost per unit measures
  • The individual must have a track record in working in a cleanroom

Key Job Competencies

  • Comprehensive practical and theoretical background on a wide range of Biopharmaceutical and pharmaceutical Process, cleanroom and utility
  • Proven experience in implementing engineering design and installation activities – typically compressed air,
  • H.V.A.C. systems, supporting Utilities, applied to both general industrial and clean room standards.
  • Min 8 years experience working with mechanical services in a manufacturing
  • Min 5 years Experience of working within a Biopharmaceitical environment in a project or Plant engineering
  • Experience with the requirements of commissioning and qualification of Facility equipment in a pharmaceutical
  • Experience with Fill Finish operations in Biopharmaceutical operations is
  • 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
  • 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
  • Cost Consciousness – works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational
  • 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
  • Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and
  • Innovation – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and
  • 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
  • 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

Job Background

Education

Qualified to Degree in an engineering discipline.

Languages

Experience

  • Management of safety requirements of the HPRA/F.D.A. and Health & Safety Executive, as defined in MeiraGTx

C&Q Engineer – FTC 12 months

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 is a key role in the site commissioning phase MeiraGTx Manufacturing Facility In Ireland for the manufacture of Advanced Therapies (Gene Therapy viral vectors). The facility will manufacture plasmid and clinical material with the ambition of producing commercial Gene Therapies in 2022. The facility requires an C & Q Engineer to assist the Head of Engineering with the implementation and operation of the site commissioning plan.

This is a fast track programme, therefore the role requires the ability to be flexible and covers a very broad remit.

Major Activities

  • Effectively working within a multidisciplinary team to Prepare, schedule and execute Commissioning and Qualification protocols
  • Lead Risk assessments for process and equipment as required
  • Develop system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems
  • Execute Commissioning and validation of manufacturing equipment, downstream equipment and processes in addition to supervising and witnessing CQ carried out by vendors
  • Develop protocols for validation projects using a risk based approach that meets regulatory requirements and industry practices
  • Review and approve Layout development and review for material and personnel flow compliance
  • Review analyze and interpret system performance data for completed validation and prepare final
  • report packages by summarizing the data
  • Investigate deviations, write investigation reports and create summary reports
  • Promote cGMP and regulatory compliance into assigned projects
  • Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Strong trouble shooting and Safety compliance experience is essential for this role

Job Background

  • BSc/MSc or BEng/MEng in Engineering or related discipline
  • 5 -7 years minimum in validation, quality systems, operations, engineering or any combination thereof
  • Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer
  • systems, sterilization) with advanced technical knowledge
  • Validation experience using risk-based approach guidelines, international regulatory requirements and standards
  • Experience interacting with or creating material for representatives of regulatory agencies and executive level staff
  • Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.

Key Job Competencies

  • Comprehensive practical and theoretical understanding of a wide range of industrial plant and cleanroom services and utility equipment
  • Proven experience in commissioning plant and equipment in a GMP environment
  • 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
  • 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 – 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
  • 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

Bioprocessing 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 main purpose of the Bioprocessing Scientist is to support Good Manufacturing Practice (GMP)-compliant activities for the production of sterile gene therapy Products.

Major Activities

  • Perform production processes, following SOPs and GMP practices to manufacture required products
  • Proficient in the use of aseptic manufacturing techniques to assure the manufacture of intermediate sterile products
  • Operate to appropriate GMP practices within clean room environment to assure continued compliance within those areas
  • Carrying out the day-to-day monitoring of the GMP facility to ensure that the facility operates in a compliant and safe manner to allow the production of gene therapy products at the required
  • Perform routine cleaning of the manufacturing facility
  • Review and update process documents as required
  • Perform the environmental monitoring of the manufacturing facility
  • Ensure that the MeiraGTx manufacturing facility and storage areas are maintained in a fit-for-purpose state
  • Conduct regular stock checks and assist in the maintenance of the stock inventory
  • Assist in stock control including ordering against defined specifications and receipt of materials, appropriate storage of starting biological products, (Quality Control QC) approval and release of materials for use
  • Comply with MeiraGTx procedures including Health and safety and GMP
  • To ensure all equipment used is calibrated/maintained and in line with SOP’s
  • Recognize and report procedural problems and deviations
  • Participate in the planning of duties to ensure customers receive products on time and in
  • Any other duties/projects as are responsible and within the skills and ability of the post holder
  • If required, support technology transfer activities as new processes are transferred into manufacturing

Key Performance Indicators

Aseptic technique qualification GMP compliance

Contamination free GMP Batch manufacture Data integrity

Key Job Competencies

Aseptic processing – Operates to appropriate manufacturing practices to avoid cross contamination and sterile processing

Problem Solving – Identifies and resolves problems in a timely manner; able to gather and analyze information; develops alternative solutions; works well in group problem solving situations

Leadership – exhibits confidence in self and 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

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.

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; occasionally exposed to fumes or airborne particles; the noise level in the work environment is usually moderate.

Job Responsibilities

Compliance with GMP

Job Background

Certificate or Degree in Bioprocessing or Degree in a relevant scientific discipline with practical laboratory elements (or equivalent) or relevant previous experience.

Experience in pharmaceutical product manufacture (preference for biologics and aseptic manufacture) Good understanding of GMP

Practical experience of sample preparation and analysis Need to be numerate

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