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Job Title: Analytical Scientist – API or Drug Product
Location: South East UK
Company: Global Pharma
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.