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
Qualified to Honours Degree level in an appropriate science discipline, preferably Biotechnology
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.