Process Scientist

Job Description

An amazing opportunity has arisen for a Process Scientist at our latest state-of-the-art, fully integrated vaccine facility in Dundalk, Ireland. You 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.

Bring energy, knowledge, innovation and leadership to carry out the following:

• 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
• 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.
• Participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.
• 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.
• Work closely with manufacturing, and quality teams to ensure smooth and robust process.
• Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the DS MSAT lab area.

In order to excel in this role, you will more than likely have:

• At least a Bachelor level of education in Biology, Biotechnology, Microbiology, Chemistry or Pharmaceutical Engineering or related Science or Engineering major.
• 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.

• cGMP Guidelines
• Laboratory Experiments
• Mammalian Cell Culture
• Process Engineering
• Product Formulation
• Standard Operating Procedure (SOP) Writing
• Sterile Manufacturing
• Troubleshooting

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing inclusive, talented, and committed people together.