This leading global biologics organisation provides and offers comprehensive integrated and customisable services to the Biopharmaceutical and related industry sectors from contract development services right through to contract manufacturing services to some of the largest biopharma and pharma organisations globally. Recently, this business has announced expansions into geographies such as the U.S and most recently Ireland, where significant investment has been undertaken to build a new cell culture green-field manufacturing site which once built, will be the largest single use biologics manufacturing plant globally. This site has been designed to run continuous bioprocessing, a next-generation manufacturing technology which will be implemented for the first time at this site and once complete will employ in the region of 400 staff. With this expansion, an exciting opportunity has arisen for a MS&T Lead (Associate Director) to join the organisation at the start-up phase in leading this business through construction and into manufacturing.
- Build newly formed MSAT function in establishing clear team identity, roles and responsibilities and hand off's with other functions.
- Drive improved technical understanding of our customer processes to inform a technical improvement agenda
- Provide oversight of the design, construction and qualification of the new MSAT laboratory.
- Serving as biologics drug substance (inclusive of upstream cell culture and downstream purification) process subject matter expert, providing technical oversight to teams, and coaching to associate staff.
- Experimental design, execution, data analysis and interpretation.
- Execution of satellite runs.
- Interpretation of trends observed in commercial process monitoring (including continued process verification (CPV), statistical process control (SPC) multivariate analyses), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
- Deviations and investigations.
- Scale-up through technology/process transfer to clinical and commercial manufacturing.
- Establish and maintain scaled-down models of cell culture production processes.
- Utilize fundamental engineering principles relevant to bioprocess unit operations for scale-up and technology transfer.
- Provide technical input to manufacturing process validation plans, protocols and reports.
- Design, execute and document experiments to support manufacturing improvements and investigations.
- Authoring and reviewing standard operating procedures and technical reports. Supporting global regulatory submissions as needed.
- Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
- Ph.D. or M.S. in Biochemistry or Biochemical/Chemical Engineering or related field with 10-25 years of collective industry experience in mammalian cell culture or recovery process development, scale up, process characterisation, process validation, and commercial manufacturing.
- Technology transfer to commercial facility and trouble shooting skills are essential for this position.
To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 632 1865 for a confidential discussion.