R&D LyophilISAtion Scientist
R&D Lyophilisation Scientist - County Waterford. Job Purpose 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. Key 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. Minimum Qualifications & Experience Sought: • 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. This job originally appeared on RecruitIreland.com.
251 days ago