R&D Lyophilisation Scientist
RPG Recruitment
Waterford, IE
6d ago

R&D Lyophilisation Scientist

R&D Lyophilisation Scientist role in a fast growing US Multinational pharmaceutical company based in Waterford.

The purpose of this role is To support the R&D department in the design and scale-up of lyophilisation processes suitable for clinical production, including cycle optimization, robustness studies, and technology transfer.

Reporting to the Head of R&D, responsibilities include in conjunction with company Stakeholders

  • 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.
  • The ideal candidate will have

    Qualifications :

  • Qualified to Honours Degree level in an appropriate science discipline, preferably Biotechnology
  • Experience :

  • Minimum five years’ experience within the pharmaceutical industry, preferably in a Biopharma role
  • Significant exposure to Lyophilisation & cycle development
  • Ideally have worked within an aseptic fill finish environment
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.
  • Apply
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