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Collins McNicholas

Job Title: Analytical Scientist – API or Drug Product

Location: South East UK

Company: Global Pharma


Role Responsibilities:


We are currently recruiting for an enthusiastic and innovative Analytical Scientist to support either API or Drug Product to be based in the South East.

Main Duties and Responsibilities:

  • To perform routine and non-routine analysis using traditional and modern analytical techniques, as required by the Lead Scientist or client representative.
  • To support formulation development/API/ Drug Product process and development through hands-on generation of accurate and precise analytical chemistry data using routine laboratory techniques such as liquid chromatography (HPLC,UPLC),  USP / EP dissolution testing, gas chromatography (GC), mass spec and Karl Fisher titration.
  • Supporting API or Drug Product process development through hands-on generation of accurate and precise analytical chemistry data development and execution of method validation protocols
  • Providing hands-on analytical support to process development chemists (setting up analytical methods, troubleshooting methods and instrumentation, interpreting results, running samples and lab IPCs).
  • Identifying, tracking and tabulating process related impurities through laboratory and pilot scale development studies.
  • To develop assay / purity methods and assess method robustness / ruggedness.
  • To generate data in support of clinical stability studies.

Additional Role Responsibilities, depending on experience may also include:

  • To develop dissolution methodology that will provide some measure of an in vivo / in vitro relationship and serve as a quality control procedure.
  • To design and execute of studies to ascertain degradation mechanisms in the solution and solid state.
  • Assessment of process changes on the quality and the stability of Drug Products, intermediates and APIs, recording the impact of the changes on the impurity profiles.
  • To assess stability risks by evaluating process changes and impact on degradation chemistry or dissolution profile, for example, using DoEs and accelerated stability studies.
  • To transfer analytical methods to other laboratories and remote sites.
  • To develop and support Process Analytical Technology (PAT) techniques.

Experience and Qualifications

  • A minimum of 3 years, experience in a Research & Development analytical laboratory setting.
  • Method Development and Validation experience required.
  • A sound, fundamental knowledge of Chemistry is essential.
  • Good foundation and experience with traditional analytical techniques as well as modern instrumental equipment (HPLC, UPLC, MS, NMR (liquid), vibrational spectroscopy, dissolution, Karl Fischer, and UV spectroscopy).
  • Must possess basic knowledge of analysis methods and tools.
  • Appropriate relevant experience of pharmaceutical analysis in a development laboratory within a group organization.

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