You will join an exciting and innovative business whose mission is to provide services across the drug development lifecycle to the pharmaceutical and biotech sectors.
You will be responsible for developing and validating/transferring analytical cleaning methods for the cleanliness verification of production equipment while carrying out cleaning assessment to GMP standards. The role will require you to liaise with the Operations team (manufacturing, development) to arrange cleanliness verification with minimal impact to production operations. You need to maintain records of all cleaning assessments carried out and review analytical documentation as well as report and investigate incidents of cleaning verification failures. You will use your excellent communication skills to delegate and monitor the progress of work on a daily basis and update the senior staff at the department on the progress of work. You will also compile GMP documents such as analytical methods, SOP’s, and protocols.
- BSc (or equivalent) in Chemistry or a Life Science subject with a significant chemistry component
- Significant experience of working in a GMP drug product development laboratory
- Significant experience of developing/validating HPLC method and thorough understanding HPLC theory
- Significant experience of supporting pharmaceutical equipment cleaning verification
- Experience in the use of TOC for equipment cleanliness assessment
- Experience in supervising staff or line management (advantageous)
- Experience of using Empower chromatography data capture system (advantageous)
- Experience in the use of LC-MS systems (advantageous)
- Experience in supporting Equipment cleaning validation (advantageous)