BIOPROCESSING SCIENTIST required by CareerWise Recruitment for our clinical-stage gene therapy client for their multi-million euro expansion at their facility in Shannon, Co. Clare.
The BIOPROCESSING SCIENTIST will drive day to day manufacturing processing and support Good Manufacturing Practice (GMP)-compliant activities for the production of sterile gene therapy Products.
Role of this position
- 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.
- If required, support technology transfer activities as new processes are transferred into manufacturing.
- 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)
- Leadership experience including planning, problem solving, training and personal development.
- 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.
Please call Conor Twomey today for further information on 021 4297422 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)