Scientist 3, Analytical Development - San Diego
1 month ago
Job summary
This facility offers an array of services that support oral and injectable dosage forms including preformulation testing formulation and analytical development cGMP manufacturing and clinical packaging labeling worldwide distribution Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our clients most challenging compoundsResponsibilities
- Develop cleaning verification methods and stability-indicating methods for peptide and small molecule Active Pharmaceutical Ingredients API intermediates drug products from scratch
- Perform train others on a variety of analytical techniques including but not necessarily limited to: analytical balances pH meters high performance liquid chromatography HPLC UPLC UV Vis spectroscopy Gas Chromatography GC USP dissolution testing apparatus moisture analysis by Karl Fischer disintegration Pion µdiss DSC TGA PSD PXRD SEM hardness friability testing Troubleshoot optimize analytical methods for characterization drug products intermediates Perform qualification studies determine suitable transfer Quality Control Communicate results internally externally updates formal reports necessary Independently lead discussions clients technical topics relating project Exercise technical discretion critical thinking design execution interpretation experiments independently minimal supervisor assistance Data interpretation conducted independently Assist creation revision new department-wide site-wide procedures company SOPs Clear accurate record keeping laboratory notebooks secondary review colleagues work scientific accuracy compliance Collaboration Quality Assurance Quality Control method validation compliance issues collaborate departments troubleshoot technical issues Familiarity current GMP regulations required Individuals stay abreast current scientific technologies maintain state-of-the-art nature Catalents services Proactively communicate strategy clients Business Development generate proposals change orders Support business aspects position working supervisor billing communication all work proposals supervision Other duties assigned
Job description
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