R&D Principal Scientist
Pe Global
Waterford
Key Responsibilities include but are not limited to: Advise on all aspects of the lyophilisation cycle development, optimization, scale up and technology transfer of finished products. Complete accelerated stability testing plans that demonstrate suitability of Lyophilised formulations. Complete required batch documentation records with accuracy and legibility. Perform in-process checks, complying with current good manufacturing practices to ensure product quality. Track and report deviations to a process and participate in quality improvement projects. Act as R&D liaison between relevant teams 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. Ensure that all work is carried out in compliance with the required standards to conform with regulatory requirements. Requirements: An honours in Science/Biotechnology (or a related discipline. You MUST have at least5+ years’ experience. Ideally have worked within an aseptic fill finish environment. Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.
1963 days ago