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Method Development Scientist
We are currently looking for a Method Development Scientist to join a leading Pharmaceutical company based in the Nottinghamshire area. As the Method ... View Job
The role entails the analysis of pharmaceutical raw materials, APIs, and finished products to ensure compliance with internal and regulatory specifications. Daily tasks will involve general chemical analysis including stability testing, various laboratory support activities (method validation, instrument calibration and qualification), documenting analytical data, writing reports and SOPs all in accordance with cGMP.
The ideal candidate should have proven competence in analytical techniques, especially HPLC, GC, FTIR, UV, and wet chemistry testing. Ideally they will be a chemistry graduate (or equivalent) with knowledge and experience of working in a GMP environment performing stability testing, Pharmacopoeial testing, and method validation.
- Perform analytical testing using GC, HPLC, TLC, FTIR and other required techniques in accordance with written procedures - Qualification of Laboratory instruments and validation of analytical methods - Ensure that all analytical operations are performed in accordance with current cGMP regulations - Record data into appropriate records and notify the line manager of any OOS, OOT, OOE or questionable results - Create and update documents in accordance with cGMP and company procedures
- Degree or above in chemistry (or related science discipline) - Extensive experience in Pharmaceutical QC testing and GMP (ideally small molecule) - HPLC experience - Experience of GC, FTIR, and other routine analytical instrumentation - Experience of Pharmacopoeial testing and/or the use of Pharmacopoeias - Experience of stability testing and ICH guidelines - Experience of HPLC method validation (method development experience would be desirable) - Experience in completing OOS investigations, deviations, CAPA, and Change Controls - Knowledge and understanding of Data Integrity requirements - Educated to degree level in chemistry (or related science based subject) as a minimum - Knowledge and experience of QC analytical testing and the use, and troubleshooting of, analytical instrumentation - Good communication, presentation, coaching/training, and team working skills - Computer literate - High level of numeracy - Excellent attention to detail and concern for quality'
- Experience of using the Empower CDS - Knowledge of CSV requirements in a GMP environment - Experience of Pharmacopoeial testing and the use of Pharmacopoeias