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.
- 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.
Compliance with GMP
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.