- Technical understanding of the development and validationof LCMS methods.
- Appreciation of challengesassociated with the analysis of trace impurities in pharmaceuticalmaterials.
- Strong working knowledge ofquantitative chromatographic analysis and the necessary laboratoryskills required to achieve accurate precise and reliable data firsttime.
- Ability to work independently and todocument analytical results and conclusions through presentationsand technical reports.
- Oral and writtencommunication skills with emphasis on clarity ofcommunication.
- Ability to follow scientificprotocols / methods and departmental procedures with excellentattention to detail.
- Highly motivatedselfdirected and proactive.
- Creativeentrepreneurial attitude with appetite to work in a fastpacedenvironment.
- Ability to execute key prioritiesto timelines whilst effectively balancing multiplepriorities.
- Interpersonal skills and abilityto work with personnel at all levels.
- Responsibilities will include but are notlimited to the following:
- Supporting the LCMStesting of drug product lots for the quantitation of small moleculeimpurities.
- Designing studies to evaluatemethod suitability (linearity accuracy precision etc.).
- Developing appropriate sample preparation methods in arange of different matrices.
- Executingaccelerated drug product stability studies including trending ofimpurities data.
- Performing experiments inaccordance with good laboratory practices (GLP) establishedbusiness processes and protocols and applicable SOPs.
- Identifying and investigating atypical analyticalresults.
- Troubleshooting analyticalinstrumentation.
- Documenting laboratory workin a detailed clear and timely manner in compliance with GLPrequirements.
- Selecting appropriatepresentation techniques for analytical datasets in order to deliverconcise headline results to stakeholders in a timelymanner.
- Bachelors Degree inrelevant scientific field.
- Practicalanalytical laboratory experience in the field of quantitativechromatographic analysis.
- Desirable
- Experience with LCMS and associated quantitativeprocessing software.
- Experience in thedevelopment / validation of LCMS methods for traceanalysis.
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Analytical Scientist - Kent, United Kingdom - Tekwissen UK
Description
Overview:TekWissen Group is a workforce management providerthroughout the UK Europe and many other countries in the world. Thebelow client is an American multinational pharmaceutical andbiotechnology corporation.
Job Title: AnalyticalScientist Location: kent sandwich CT139ND Job Type: 12 Months Job Description TheMaterials Characterisation Team based within the AnalyticalTechnology Function of clients Global Supply Technology andEngineering (GT&E) department are looking for a scientist tosupport the quantitation of small molecule impurities using liquidchromatography with mass spectrometry. This is to enable technicalsupport for complex analytical and process investigations alongwith the assessment and support of onmarket products in the areasof nonconforming materials line extensions and second sourcingactivities.SKILLS NEEDED:
ROLERESPONSIBILITIES:
