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Principal Scientist - Lyophilisation, Waterford



Waterford, Ireland 

Job Category:

Biotech/Pharma, Science

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Job Description:

The Opportunity

Team Horizon is looking for a 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.

The Role
  • 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 Person
  • 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
  • Excellent knowledge of project management techniques and tools (e.g. MS Project)
  • Excellent computer skills to include MS office, ECDL certification an advantage
  • Knowledge of electronic document management system

Employment Type:

Full time
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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