Method Development Analyst

Job title: Method Development Analyst
Contract Type: Contract
Location: Speke, England
Salary: £10 - £22 per hour
Reference: 78929
Contact Name: Paul Rees
Phone Number: 0161 942 4035
Job Published: 16 days ago

Job Description

Analytical Scientist – Analytical Service Centre, Speke

Position Description

Provide technical and professional expertise to the Analytical Service Centre (ASC) Laboratory, supporting manufacturing / customer supply, commercialisation, quality and regulatory aspects of the business.

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 internal / 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 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
Minimum Qualifications (education, experience and/or training, required certification
  • A minimum of an upper second class honours degree (or equivalent) in Chemistry or Biochemistry (or related discipline)
  • Strong, proven experience gained in a top tier pharmaceutical analytical environment
  • Strong technical understanding of the following techniques : HPLC, GC, Dissolution, Particle Size Analysis
  • 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
Additional Preferences
  • Knowledge of statistical data analysis techniques (eg JMP)
  • Experience of Waters chromatographic integration package ‘Empower’ would be beneficial