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  • DUBLIN 2
  • Job reference number:15425869
  • Client ID:RI/AM16452
  • Posted on:07-FEB-2019
  • Location:WATERFORD
  • Job type:PERMANENT

Principal Scientist - Lyophilisation. County Waterford.

Our client seeks a Lyophilisation Scientist for a role which sits within the Research & Development team who operate in a state-of-the-art sterile fill-finish site and are in the process of working with a new line of products. The role is to support the design and scale-up of lyophilisation processes suitable for clinical production, including cycle optimisation, robustness studies, and technology transfer.

Interested applicants should have biotechnology educational attainments, a minimum of five years’ experience within the pharmaceutical industry, preferably in a Biopharma role with significant exposure to Lyophilisation & cycle development, and have ideally worked within an aseptic fill-finish environment.

Core duties:
• Advise on lyophilisation cycle development, optimization, scale-up and Technology Transfer of finished products using state of the art techniques
• Design and execute accelerated stability testing plans that demonstrate suitability of Lyophilised formulations
• Complete required batch documentation records with accuracy and legibility
• Ensure product quality by performing in-process checks, complying with current good manufacturing practices
• Track and report deviations to a process, initiating quality improvements and participating on quality improvement projects as required.
• Act as R&D liaison between relevant Managers, Q A, Research, Tech Services, Engineers and Maintenance personnel in all matters regarding freeze drying
• Participate on manufacturing project teams to assist with cycle development through collaboration with R&D.
• Review work scope, rationale, approvals, changes to appropriate equipment/systems and re-qualification activities
• Assist in the training of sterile operators or cross-training in other areas.
• Troubleshoot and perform adjustments on equipment as required.
• Ensure that all work is carried out in compliance with the required standards to conform to company, cGxP, health and safety, environmental and regulatory requirements.

Applicants should have:
•An honours degree in Science/Biotechnology (or a related discipline)
• At least 5 years’ experience
• Significant exposure to Lyophilisation & cycle development
• Ideally have worked within an aseptic fill-finish environment
• Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.
• Self-starter who enjoys working in a fast paced environment

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