Lead Process Engineer
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 the Lead Process Engineer, you will be responsible for devising, implementing and improving a process engineering strategy and leading process improvement projects to ensure excellent performance across a balanced scorecard within the state-of-the-art MeiraGTx London manufacturing facility..
- Responsible for devising and implementing a process engineering improvement strategy within manufacturing (to achieve balanced business scorecard goals for safety, quality, flow, cost, people, improvement)
- Accountable for leading major process engineering changes within the GMP gene therapy manufacturing facility
- Accountable for process data and control systems improvement for all critical manufacturing equipment.
- Accountable for developing and sustaining technical documentation systems to increase manufacturing equipment understanding e.g. drawings, operational guides, etc.
- Accountable for change management activities for process engineering equipment and systems within the scope of manufacturing, with a responsibility to act as process safety technical authority for all changes.
- Responsible for the design, planning and project management and delivery of proactive, corrective and preventative improvements to the manufacturing process, procedures, and ways of working
- Responsible for leading internal investigations into manufacturing deviations and safety incidents
- Responsible for preparing and fronting process engineering topics during audits and regulatory inspections
- Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
- Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken
- Responsible for ensuring that any GMP documentation assigned e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions areclosed timely and in a right-first-time state
Key Performance Indicators
- Safety performance of Manufacturing including compliance
- Quality performance of Manufacturing including compliance
- Implementation of performance management for process equipment
- Process engineering project timeliness and quality
Key Job Competencies
- Process engineering design and understanding – highly proficient and experienced in the design and improvement of chemical / biochemical processes ideally in a regulated industry
- People-focused – drives own work and improvements to benefit the users and stakeholders of the manufacturing process, engaging with them proactively at all stages
- Data driven – highly proficient in acquiring, manipulating and analysing data to support performance improvement
- Strategic Thinking – capable of making decisions and planning activities in a balanced manner that aligns with the overall ambition of the organisation and drives the business forward.
- Leadership – exhibits confidence in self and builds confidence with stakeholders at all levels of the organisation
- 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
- Change management – capable of planning and executing change in a way that people understand and adopt into their daily work
- Systems thinking – understands interrelationships between activities and systems and optimises ways of working to deliver the best overall results
- Planning/Organizing – prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives
- Influencer – understands how to influence people with diverse backgrounds at different levels of the organisation to adopt better approaches consistently
- Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence;
- 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.
- University degree in Chemical / Process / Biochemical Engineering
- Engineering Chartership desirable
- Professional experience in process design, project management and continuous improvement
- Good understanding of pharmaceutical Good Manufacturing Practice (GMP) desirable