We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dundalk. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This role will play an important role within our vaccine manufacturing MSAT lab, primarily providing process support to upstream and downstream lab scale experiment planning and execution.

Duties:

• Lead and support upstream and downstream related studies at small scale in MSAT lab.
• Strong background in setting up cell culture seed train, bioreactors setup and running process smoothly.
• Strong background in TFF, clarification, filtration and dilution of drug substance.
• Strong understanding of upstream and/or downstream process development
• Strong understanding of upstream and/or downstream scale down model
• Write reports to a high standard and present data within the group
• Person will be flexible to support for some of the weekend work
• Working flexibility to support weekend work if required
• Support manufacturing to perform any study required during, engineering, validation or clinical batches.
• This role will support satellite runs of vaccine process to ensure the efficient and consistent production of vaccines.
• The ideal candidate will possess a deep understanding the drug substance process as well as a passion for problem-solving and process improvements in a GLP environment.
• Ensure a high standard of record keeping and documentation of experiments and investigations.
• Support in drafting SOP, protocols, MBRs and other technical documents and revision of documents including technical memo
• Have in depth knowledge of vaccine drug substance process and understand the basis of specification and critical attributes.
• This role will partner with the MSAT team and DS Technical team to provide comprehensive technical leadership to DS manufacturing.
• Support equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.
• Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the DS MSAT lab area.

• Masters or Bachelor’s degree in Biology, Biotechnology, Microbiology, Chemistry or Pharmaceutical Engineering or related Science or Engineering major or equivalent experience.
• Minimum 2-3 years working in a biological, or vaccine clinical or commercial manufacturing
• Experience in cell culture process development and bioreactor operation
• Experience in downstream process development
• Experience in bioprocess development, biopharmaceutical production, and/or biological process validation experience with successful tracking record.
• Biological production process validation experience will be an advantage
• Detail-oriented organizational skill to track and maintain project activities
• Experience in troubleshooting and investigating critical deviation, performing risk analysis on production process, coordinating technical transfer, and executing process validation.