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.
• 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.

Key Performance Indicators

• Aseptic technique qualification .
• GMP compliance.
• Contamination free GMP Batch manufacture.
• Data integrity.

Key Performance Indicators

• 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 analyse 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.

Job Responsibilities

• 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.

Experience / Professional Background

• 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.