Our client, a biopharmaceutical company located in Tipperary, is seeking an Analytical Scientist. The successful candidate will join team as a scientist supporting small molecule drug substance supply in our client’s company and external partner manufacturing sites in Europe and will support and provide comprehensive and scientifically appropriate analytical test methods to address quality requirements for release of pharmaceutical materials to be used for market supply.
- Support the development and optimization of reliable, validated, analytical methods to characterize the quality attributes of drug substances.
- Assures that right information on the quality of raw materials and in-process control points is provided to support process optimization studies with a clear linkage to regulatory filing requirements.
- Manages change control for analytical methods and specifications for assuring the quality of drug substances for inclusion in the regulatory submissions.
- Provides the analytical information for filings and responses to questions from regulatory agencies.
- Executes laboratory work to characterise extraneous matter using SEM/EDX, microscopy and FTIR techniques in support of GMP investigations.
- In partnership with the Quality organization, formulates and continually updates appropriate GMP procedures for analytical methods.
Qualifications & Experience:
- Qualification (BSc) in science with experience of analytical chemistry techniques.
- Minimum 1 year’ experience.
- Experience in small molecule analytical development or quality control analytical testing.
To apply for this job email your details to email@example.com.