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May 22 2018

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Job Opportunity: PRINCIPAL SCIENTIST - LYOPHILISATION:ICDS Recruitment

Job description:


   » Job ID.:15350617
   » Employer ID.:RI/AM16452
   » Published:16-MAY-2018
   » income:NEGOTIABLE
   » Job location:WATERFORD
   » Employment Type:PERMANENT

 

Principal Scientist - Lyophilisation. County Waterford.

Our client seeks a Lyophilisation Scientist for a function which sits within the Research & Development team who operate in a state-of-the-art sterile fill-finish site and are in the process of working with a new line of products. The function is to support the design and scale-up of lyophilisation processes appropriate for clinical production, including cycle optimisation, robustness studies, and technology transfer.
Interested candidates should have biotechnology educational attainments, a minimum of five years’ practice within the pharmaceutical industry, preferably in a Biopharma function with significant exposure to Lyophilisation & cycle development, and have ideally worked within an aseptic fill-finish environment.

Core tasks:
• Advise on lyophilisation cycle development, optimization, scale-up and Technology Transfer of finished products using state of the art techniques
• Design and execute accelerated stcapability testing plans that demonstrate suitcapability 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 significant 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.

candidates should have:
•An honours degree in Science/Biotechnology (or a related discipline)
• At least 5 years’ practice
• Significant exposure to Lyophilisation & cycle development
• Ideally have worked within an aseptic fill-finish environment
• Demonstrated expertise in pharmaceutical / biopharmaceutical technical / manufacturing operations.
• Self-starter who enjoys working in a fast paced environment

This job originally appeared on RecruitIreland.com

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Waterford
Company Type Employer
Post Date: 05/16/2018 / Viewed 12 times
Contact Information
Company: ICDS Recruitment


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