Location: EirGen Pharma R&D Centre, Waterford
Title: Principal Scientist – Lyophilisation
Reporting to: Head of R&D and based at our R&D Centre on the Cork Road
Why is this role open?
EirGen Pharma have a new vacancy for an Lyophilisation Scientist whichsits within the Research & Development team who have just moved into a state of the art sterile fill finish site and are in the process of working with a new line of products. The role is to support the design and scale-up of lyophilisation processes suitable for clinical production, including cycle optimization, robustness studies, and technology transfer. Candidates should have biotechnology educational attainments, a minimum of five years’ experience within the pharmaceutical industry, preferably in a Biopharma role with significant exposure to Lyophilisation & cycle development, and have ideally worked within an aseptic fill finish environment.
What will you be doing?
- 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.
What we need from YOU:
- You MUST be passionate about Lyophilisation and Biopharma
- An honours degree in Science/Biotechnology (or a related discipline)
- You MUST have at least 5+ years’ experience
- Significant exposure to Lyophilisation & cycle development
- Ideally have worked within an aseptic fill finish environment
- Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.
- Self-starter who enjoys working in a fast paced environment
- You MUST enjoy working as part of a team and be fun and friendly
If you match all the above criteria and want to join the Pharma Company of the Year – SME 2017, click below to apply!