EHS Advisor (Shannon)
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
Reporting to the EHS Lead, responsible for the development, implementation and integration of the MeiraGTx DAC EHS management system with the global EHS Management Systems, supporting and advising the MeiraGTx Management Team aligning with the MeiraGTx EHS Policy and Strategy ensuring compliance to Local legislation and MeiraGTx Corporate EHS expectations. The role holder will be the MeiraGTx DAC “competent person” for EHS and will be based in Shannon however provision of advice and travel to other sites may be required depending on staffing requirements and individual expertise.
- Assist the EHS Lead and Site Management in the provision & maintenance of an EHS management system which integrates with site operations and the wider MeiraGTX Management Systems including GxP systems
- Foster a culture of continual improvement in EHS program implementation, in line with our Quality standards
- Develop and Manage the emergency response program for the site
- Record and investigate unplanned events, in line with their potential severity, and recommend actions to safeguard the safety and health of staff and improve the reliability of processes
- Work in partnership with Human Resources and Occupational Health to deliver health surveillance, advise on Occupational ill-health, disability, reasonable adjustments and physical and mental wellbeing provision for staff
- To provide competent and timely advice within the boundaries of their own competence
- To maintain relevant documentation, policies, procedures, etc.
- To perform internal audits & inspections
- To assist with the preparation for, and participate in, external audits
- Manage and track EHS Actions to completion
- To create and maintain legal registers
- Input into management meetings
- To design and deliver relevant training
- To communicate the above to relevant personnel via existing channels including the provision of relevant reports
- Provide reports to, and advise, Management and the MeiraGTx DAC EHS Committee
- To prepare for emergencies
- To cover for annual leave within the EHS Team
- Maintenance of professional knowledge and compenency through agreed CPD
- Provide support and oversight to site construction activities
Key Performance Indicators
- Timely provision of advice and support
- Contribution to the MeiraGTx Management System
- Timely production of reports and provision of information for relevant meetings
- Participation in Management Meetings, as appropriate
- Collaboration with key stakeholders and service providers (inc. HR, OH, Site Management etc.)
- Audit and inspections delivered
- Actions tracked and closed in an effective and timely manner
- Training delivery
- Continual Professional Development
Key Job Competencies
- Teamworking – Works effectively with the EHS Lead and staff at all levels.
- 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.
- Engages with the cultural developlement of the startup and provides support and guidance to all other function teams
- Manitains an up to date knowledge of local regulations and proactively seeks out environmental and OH iniatitives to support the buisness and site teams.
- Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops pragmatic 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.
Post holder will be expected to enable and influence business units compliance with the MeiraGTX EHS Management System. This will involve influencing those outwith their direct control and working with site management to deliver EHS compliance.
Polst holder will recommend expenditure for approval by the Lead of a business unit or the EHS Lead
Be highly motivated
Be meticulous in attention to professional standards
Respond well to time constraints
Have the ability to work in a team based environment and can engage, motivate and work with people.
Be pragmatic and solution-focussed
Be excellent organisational and co-ordination skills
Be engaging, have and excellent leadership skills
Be collaborative, pragmatic and act as an agent for continual improvement
Recognised EHS qualification/certification (UK NEBOSH Diploma, or equivalent – Ireland Level 7/8, England Level 6, Scotland Level 10)
Minimum 3 years experience in a relevant scientific / laboratory / technical / manufacturing discipline as an EHS Advisor
First degree in appropriate STEM Discipline (Microbiology or Biological Sciences preferred)
Professional Membership equivalent to Member of the International Institute of Risk and Safety Management (MIIRSM) or Graduate Member of the Institute of Occupational Safety and Health (GradIOSH) with evidence of Continual Professional Development.
Specific Qualifications / commensurate experience in Assessing Chemical, Biological, Ergonomic, Engineering / Maintenance / Human Factors risks would be an advantage
Training qualification (Certificate Level)
Experience working in a GMP Facility and Research Laboratories
Experience / qualifications in Human Factors investigations, root cause analysis, FMEA, change management methodologies
Qualified Biosafety Practitioner / Professional
Professional Membership equivalent to Fellow of the International Institute of Risk and Safety Management (FIIRSM) or Chartered Member of the Institute of Occupational Safety and Health (CMIOSH) with evidence of Continual Professional Development
Experience of team leadership and of working with stakeholders when developing a EHS management system would be a distinct advantage.