We are looking for an experienced senior analyst to come on board to provide technical and professional expertise within the established analytical team. You will be required to have an excellent working knowledge of HPLC and GC with preferably with dissolution and empower.
Functions, Duties, Tasks
- Own and lead analytical projects within the ASC lab, ensuring that customers and management are regularly informed of progress and adherence to schedule
- Lead and perform analytical method development and validation to GMP standards and second person data verification (2PV). Lead and perform troubleshooting, method variability reduction and method improvements as required. Lead activities associated with the creation, review and approval of method validation protocols and reports, test methods and associated procedures
- Lead method transfer activities and provide expert training to Company / 3rd party laboratory staff QCL staff as required. Lead activities associated with the creation, review and approval of method transfer protocols and reports
- Maintain professional skills and knowledge by keeping current with advances in analytical techniques, instrumentation and good practices. Utilise contacts with internal / external resources.
- Liaise with the following groups within the wider Company Global Quality Laboratory team (Pharmacopoeial Reviews, Reference Standards and Global Specifications)
- Represent ASC laboratory at regulatory CMC meetings, GPLOT meetings, Escalation (EAC) meetings etc
- Act as point of contact for technical questions during GMP audits (internal and external)
- Assist the EGQL leadership team in attaining a culture of world class customer service, world class quality, continuous improvement and a commitment to excellence within the ASC Laboratory
- A minimum of an upper second class honours degree (or equivalent) in Chemistry or Biochemistry (or related discipline)
- Experience of owning and leading analytical remediation
- Strong, proven experience gained in a top tier pharmaceutical analytical environment
- Strong technical understanding of HPLC, GC and ideally Dissolution
- Excellent written and oral communication skills
- Clear understanding of the expectations of GMP within a laboratory
- Keen to join a dynamic environment which is both challenging and supportive
- Knowledge of statistical data analysis techniques (eg JMP)
- Experience of Waters chromatographic integration package ‘Empower’ would be beneficial
For more information apply and you will be promptly contacted.