Process Scientist

Orion Group Life Sciences are currently recruiting a Process Scientist on behalf of our Multinational Biopharmaceutical Client based in Dundalk on an initial 11-Month contract with potential to extend.
 
Overview
An exciting opportunity has arisen for a Process Scientist to join a vaccine manufacturing MSAT laboratory, supporting process development and manufacturing through laboratory-based experimentation and technical expertise.
This role will play an important part in providing upstream and downstream process support, leading lab-scale studies, supporting manufacturing activities, and driving process improvements within a GLP environment.
The successful candidate will work closely with MSAT and Drug Substance Technical teams, contributing to engineering, validation and clinical manufacturing activities while ensuring efficient and consistent vaccine production.
 
Key Responsibilities

• Lead and support upstream and downstream process studies at laboratory scale within the MSAT lab.
• Plan, execute and analyse small-scale experiments to support manufacturing and process development.
• Set up and operate cell culture seed trains and bioreactors.
• Perform downstream processing activities including tangential flow filtration (TFF), clarification, filtration and drug substance dilution.
• Support manufacturing by performing studies during engineering, validation and clinical batches.
• Support satellite runs of vaccine manufacturing processes to ensure efficient and consistent production.
• Troubleshoot process issues and identify opportunities for continuous improvement.
• Prepare high-quality technical reports and present experimental data to internal teams.
• Maintain accurate laboratory documentation and ensure high standards of record keeping.
• Draft and revise SOPs, protocols, Master Batch Records (MBRs), technical memoranda and other technical documentation.
• Develop a thorough understanding of vaccine drug substance processes, specifications and critical quality attributes.
• Partner with MSAT and Drug Substance Technical teams to provide technical leadership to manufacturing operations.
• Support equipment commissioning, qualification and IOQ activities during project execution.
• Identify and implement continuous improvement initiatives to enhance compliance and manufacturing capability within the MSAT laboratory.
• Provide flexibility to support weekend work when required.

 
Experience, Knowledge & Skills

• 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 with a proven track record.
• Experience in biological production process validation is advantageous.
• Understanding of biopharmaceutical cGMP quality systems and manufacturing operations is desirable.
• Strong troubleshooting and investigation skills, including deviation investigations, risk assessments, technical transfer and process validation.
• Excellent written and verbal communication skills, including presentation of technical data.
• Strong organisational skills with excellent attention to detail.
• Ability to manage multiple projects and maintain accurate technical documentation.

 
Qualifications

• Bachelor’s or master’s degree in:
  • Biology
  • Biotechnology
  • Microbiology
  • Chemistry
  • Pharmaceutical Engineering
  • Or a related Science or Engineering discipline
• Minimum 2–3 years' experience working within biological or vaccine clinical/commercial manufacturing environments.

 


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