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Bioprocessing scientist

Ennis
Cregg Group
Scientist
Posted: 16 July
Offer description

Bioprocessing Scientist Excellent opportunity for a Bioprocessing Scientist to join a thriving company in Co. Clare. Key Responsibilities: 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. Review and update process documents as required. Perform the environmental monitoring of the manufacturing facility. 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. To ensure all equipment used is calibrated/maintained and in line with SOPs. Recognize and report procedural problems and deviations. 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 any GMP documentation assigned 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. Key Requirements: Degree in Bioprocessing or Degree in a relevant scientific discipline with practical laboratory elements (or equivalent) or relevant previous experience Strong GPM experience Previous experience in a similar role Experience in pharmaceutical product manufacture (preference for biologics and aseptic manufacture) Practical experience of sample preparation and analysis Proficiency in Microsoft Office software (Word, Excel and PowerPoint) For further information please contact Loretta Flynn Skills: GMP bioprocessing scientist aseptic

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