Automation 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

As MeiraGTX begins its journey in automation and Digital Data Analytics, MeiraGTx is looking for a bright, ambitious Automation Engineering Leader who can  quickly build up  our internal expertise in our current “Operational Technology” systems, to improve system robustness and reduce our dependency on specialist suppliers and someone who can work across all functions to create a multi-year “Roadmap to Pharma 4.0” to enable phase appropriate construction of the company’s automation and DDA capability for Senior Executive endorsement and subsequent implementation across Ireland and London.

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 become MeiraGTx’s technical expert in our current control systems (including SACDA, 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 multi-year 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

  • Collaborate closely with site and global stakeholders to define and deploy automation solutions including equipment, processes, and manufacturing execution systems
  • 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
  • Lead and participate in evaluation of new technology and process automation for introduction into GMP manufacturing
  • Responsible for the site PLC-based Control System, 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 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, process data historians, and laboratory information management systems
  • Experience in pharmaceutical/ biopharmaceutical drug substance manufacturing environments and processes.
  • Proven programming and maintenance experience with PLCs and Software applications, ideally across a number of industrial platforms
  • Knowledge of Building Management/Automation Systems
  • Experience with supporting and maintaining automation and control system infrastructure, including 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 – 12 MONTH Full-Time 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

To establish and develop the processes required to carry out Technical Transfer of new products from Process Development to Manufacturing in line with CMC registration and product launch milestones.

To support the organisation and processes for project management and technical support in product lifecycle management activities including validation of manufacturing processes and methods in line with ICHQ8-10.

Major Activities 

  • Develop technical subject matter expertise in the technical support team and wider manufacturing operations.
  • 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.
  • Responsible for product lifecycle management activities including process validation of processes in line with ICHQ8-10.
  • Lead and/or provide technical support using established problem solving techniques for investigations into quality events, customer complaints and IMC actions. 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.

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.
  • Demonstrated interpersonal skills with ability to work cross-functionally both with internal and external partners.
  • Experience of transferring pharmaceutical products from Development into a GMP manufacturing environment and successfully gaining approval and launching new products commercially
  • 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

Senior 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 Senior Bioprocessing Scientist is to drive day to day manufacturing processing and support Good Manufacturing Practice (GMP)-compliant activities for the production of sterile gene therapy Products.

Major Activities

Senior

  • Plan work to achieve the most efficient use of personnel and resources.
  • Support the development of manufacturing processing.
  • Contribute to the training and development of others.
  • Promote appropriate, effective communication within the manufacturing team.
  • Assure the data integrity of all activities performed.
  • Ensure area compliance with Quality, Safety and Environmental systems and procedures.

Bioprocessing

  • 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 standards.
  • Perform routine cleaning of the manufacturing facility
  • 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 full.
  • 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

Either BTEC HNC/HND 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)

Leadership experience including planning, problem solving, training and personal development.

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.