Process Scientist Full-time

Process Scientist

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.

What you will do:

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.

What skills you will need:

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.

Advantage

• Biological production process validation experience.
• Have knowledge and understanding of biopharmaceutical cGMP quality systems and operation.
• Have excellent oral presentation skill for internal and external meeting.
• 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.

Our Companies in Ireland is one of the country's leading healthcare companies, having first established here 50 years ago. The company has a dynamic and inclusive team of over 4,000 employees currently working across eight locations in Ballydine, Co. Tipperary, Brinny, Co. Cork, Dunboyne, Co. Meath, Dundalk, Co. Louth, Carlow and Dublin, and, in addition, operate substantial Human Health and Animal Health businesses. We work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network.

As a cutting-edge, state-of-the-art vaccines facility spanning over 15,500 square metres across three stories, our Dundalk site will focus on qualification, continued product development and expanding its capabilities within our network. Featuring drug substance manufacturing, drug product manufacturing and quality control labs that will support the global supply of vaccine products – strengthening our ability to make an impact on people and patients worldwide by adding new capabilities to our already industry-leading network.

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

Preferred Skills: