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Analytical Support Scientist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Leinster
  • Sector: Science
  • Date posted: 05/09/2018
  • Job reference: BBBH86440

Analytical Support Scientist

Description

The Analytical Support Scientist has responsibility for all aspect of analytical support through development, clinical and commercial stage of new Drug Products. This involves method development and validation, testing of clinical materials and support to launch of the product. The Analytical scientist may also support improvement initiatives in any area of the analytical development business.

Principal Accountabilities

  • The Analytical development scientist is responsible for ensuring all analytical activities comply with cGMP. She/he assures compliance with all safety and environmental requirements.
  • Supports/leads the development and optimization of reliable, validated, analytical methods to characterize the quality attributes of drug substances and products for all projects. She/he is responsible for testing of drug substances and products to be used in post-proof of concept clinical supplies.
  • Assures that appropriate information on the quality of excipients and in-process control points is provided to support process optimization studies with a clear linkage to Quality by Design and regulatory filing requirements. In conjunction with the stability group, determines the appropriate expiry dating for each drug product.
  • Leads the transfer of analytical methods, specifications and development knowledge for the drug substance and product. Establish relationships with key Supply and outsourcing partners that facilitate a clear understanding of analytical issues and product timelines. Continually executes the analytical elements of project to assure attention to critical issues and appropriate resourcing (by supporting functions) to meet project needs and timelines. In conjunction with the analogous areas in Supply establishes clear expectations regarding method transfer information content and logistics.

Qualifications

  • This position requires a B.Sc. (or equivalent experience base) in analytical biochemistry pharmaceutical science or a related discipline and a minimum of 5 years' experience in analytical biochemistry or a related pharmaceutical drug development area or a PhD in analytical biochemistry or associated disciplines.
  • The incumbent must have demonstrated problem solving, communication and people management skills.
  • Strong scientific understanding of analytical methodology, process optimization support needs and knowledge of relevant regulatory requirements, including GMPs is important.
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