Description:
Our client a leading Pharma company based in Waterford requires an R&D Lyophilisation Scientist 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.
Minimum Qualifications and Experience:
- 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.
Responsibilities:
- 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