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Employer ICDS Recruitment
Job Title R&D LyophilISAtion Scientist
Description

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
Location Waterford
Date Added 8 days ago
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