Are you familiar with ICHQ2 guidelines? Do you have a strong background in method development? Have you previously developed methods for new compounds? Then I may have the perfect role for you!
Method Development Scientist
Due to expansion, my client a global pharmaceutical company based in Macclesfield, is looking to recruit a number of experienced Method Development Scientists.
The purpose of this job is to provide analytical support and potentially the project management of drug substance development projects from early phase through to clinical filings. The role will involve liaising with both internal clients and external collaborators and duties may include providing direct analytical support to process chemists, developing and validating analytical methods and providing technical support to in-market Active pharmaceutical ingredients. The role will also involve the authoring of key analytical documents such as Analytical Testing Plans and method/validation protocols.
Key responsibilities of the Method Development Scientist are:
* Adhering to the principles of GMP including good documentation practices.
* Managing the performance of and training junior lab personnel, reviewing their workload and driving development.
* Planning, organising and reviewing the work of junior lab personnel to test samples and report results according to established analytical methods.
* Completing the relevant documentation/investigating any OOS or OOE results.
* Checking and reviewing laboratory write-ups.
* Ensure all raw data are archived according to established procedures.
* Writing, updating and reviewing methods, specifications, protocols, certificates of analysis and reports.
* Ensuring laboratory equipment is calibrated and maintained and data are backed-up according to established procedures.
* Performing analysis using HPLC, GC, UPLC and other analytical techniques to support drug substance manufacturing
The ideal candidate for the Method Development Scientist:
* A BSc or equivalent in Chemistry or Organic Chemistry is essential.
* A sound, fundamental knowledge of Chemistry is essential with an emphasis on method development or method validation.
* Knowledge and experience within a pharmaceutical product and chemical development environment and an understanding of the drug development process would be desirable.
If you would like to join a large global CRO and are an experienced analytical chemist with a good understanding of method development please apply now!
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