Bioprocessing Scientist

Your mission

Job Description

• 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.
• 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 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.

• Compliance with GMP
• 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 to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state comply with MeiraGTx procedures including Health and safety and 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.