Your mission
The main purpose of the Bioprocessing Scientist is to support Good Manufacturing Practice (GMP)-compliant activities for the production of sterile gene therapy Products.
Job Description
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 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 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.
Job 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. Needs to be numerate.
* Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred.
Why us?