Our client based in Tullamore is operating a 20,000 square foot facility which will focus on the manufacture of biopharmaceutical drug substance for clinical trials and commercial product.
Summary of Role:
The role of this key team member within the Development Department will include responsibility for the development and validation of processes for recombinant antibodies for veterinary use. This will include working with teams both in the company and externally with Contract Manufacturing Organisations for some of the process development activity and also for technical transfer of the process into the facility in Tullamore.
• To support the development, optimisation, scale-up and validation of all steps in our monoclonal antibody downstream processes.
• Work with external partners to provide the necessary technical support for successful completion of projects including the transfer of processes into the facility
• Support the writing of Batch Manufacturing Records, SOPs, and other quality system documentation required for GMP manufacture
• Provide hands-on technical support for all manufacturing activities including buffer / media preparation, cell culture and purification processes
• Provide technical input and support writing of technical reports required for regulatory purposes
• Participate in Quality and Safety regulatory audits
• Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices
• Carry out manufacturing as per Batch Records using chromatography and ultrafiltration diafiltration steps.
• Complete buffer preparation for process steps.
• Filter integrity testing and virus clearance steps in the downstream process.
Qualification and Experience:
• M.S. in Chemical/Biochemical Engineering or related Biological Sciences with 2 years of industrial experience or B.S in Chemical/Biochemical Engineering or related Biological Sciences with 5 years of industrial experience.
• Previous hands-on experience running chromatography systems is required.
• Experience developing and scaling up of downstream processes is preferred.
• Protein purification, lab-scale and pilot scale
• Skills chromatography and filtration systems
• Working in a controlled regulated environment e.g. GMP/GLP
• Knowledge of analytical methods required for protein characterisation
• Knowledge of key suppliers of process materials and equipment including disposable systems
• Experience working with external contractors
• Excellent project management capability
• Excellent verbal and written communication skills. Ability to maintain very clear records of work completed
• Ability to work effectively as part of a team across all departments in BIONUA
• Knowledge and understanding of the workings of protein purification techniques using Unicorn software is required.
• Understanding of process characterisation and ability to write risk assessments and technical documents.
Clodagh Nerney | Tel: +353 (0) 1 507 9254