Reference: 110 17/11/2021 16:16:01

Technical Specialist QMS .

Rushden - United Kingdom Depending on experience

Charlton Morris have partnered with a leading CRO in Northamptonshire to find a Technical Specialist QMS. Based in their centre of excellence for Radiolabelled Sciences; our client is incorporating both Metabolism (which includes Clinical Metabolism), Pre-clinical ADME, In vitro and DDI services, Large Molecule Metabolism, Environmental Fate, Plant Metabolism and Metabolite Identification in addition to Chemistry which also includes API and IMP manufacture. 

Purpose of the Technical Specialist: To continue growth and success, we are seeking for a Technical Specialist Quantitative Mass Spectroscopy (Bioanalysis). To use expertise in quantitative LC-MS/MS to develop/validate and trouble shoot methods for regulated bioanalysis and other areas of the department.

Roles and Responsibilities:

  • Perform method development/validation on large and small molecules
  • Provide analytical trouble shooting support across the department, as required.
  • Take full responsibility for the conduct of experimental work required to successfully fulfil all the requirements of a study to the timelines stated in the Study Plan.
  • Calculate and QC check data and process batches as required
  • Review data obtained and prepared study updates and study data for discussion internally and for communication to the client whist effectively communicating with clients regarding study progress and addressing clients’ comment
  • Effectively communicate with clients regarding study progress and address client comments.
  • Maintain and write SOPs, as required.
  • Act as an analytical project manager and or principal investigator on stand-alone bioanalysis studies and quantitative mass spectrometry component of studies for other areas of the department E.g., ADME, In Vitro & DDI, Env. Fate, Plant Metabolism
  • Prepare worksheets to coordinate experimental activities, prepare study plans, reports and address findings arising from QA audits and process inspections

Qualifications: PhD, MSc, or BSc (Hons) in Chemistry or related subject

Experience:

  • Experience of regulated small and/or large molecule bioanalysis including method development and validation of LC-MS methods and trouble shooting in a CRO or Pharmaceutical Company.
  • Experienced Study Director/Analytical Project Manager in a GLP/GCP facility
  • Experience of using quantitative Mass Spectrometers e.g. Sciex 5500 and 6500

Key Knowledge and Skills:

  • Recognised expert in Bioanalysis with deep knowledge of the of development and validation of quantitative LC-MS methods
  • Expert in the development of sample extraction and work-up methods including use of automation platforms (e.g. Hamilton, Tecan)
  • Proficient in the use of relevant software e.g. Analyst and Watson
  • Thorough understanding of the regulated bioanalysis guidelines
  • Proficient in the use of PK software e.g. WinNonLin
  • Project Management
  • Scientific data interpretation, reporting and presentation skills
  • Effective written and verbal communication skills, including the ability to effectively present scientific findings to colleagues and clients
  • Organisational skills
  • Problem solving
  • Prioritising and scheduling
  • Understanding of the drug development process
  • Good knowledge of Microsoft Office software

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