Bioprocessing Scientist

The 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 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 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.

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.

Job Responsibilities

Compliance with GMP.

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.