Your missionThe 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 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 SOPs.
- 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.
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).
- 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.
About usMeiraGTx 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 team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including cGMP required by the MHRA in the UK and the U.S. 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.
MeiraGTx is an equal opportunity employer. 