Support department and teams by running analytical assays to ensure that cell culture/fermentation and purification processes are working properly. Obtain and transfer analytical assays to/from other work groups and company sites, and develop methodologies replicable company wide.Successfully established all supporting analytical methods to support the site shift from mammalian to microbial productionPerformed analytical transfer on 24 methods between CRO’s, internal development and QC laboratories Supported process development activities to meet project goals and timelinesIdentified and understood new technologies with potential to increase efficiency and capability (eg. PCR (Sybr Green and TaqMan), Pico Green, UPLC)Transferred and developed the iCE280 method in the BPS labSupervised time and work assignments for student co-opGenerated reports summarizing data, making appropriate conclusions and troubleshooting issues with experimental workDesignated BPS safety officer responsible for implementing new safety procedures and conducting safety auditsEstablished rPA, RP, IEX, and SEC HPLC methodsSet up a sample submission and reporting procedure which saved approximately 2-3hrs per day per analyst

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Biochemical testing of clinical phase biopharmaceutical drug substance and drug product including release, in-process and stability testing, as well as assay optimization. Obtained and transferred analytical assays to/from other work groups and company sites.Conducted transfer, evaluation, optimization, development, qualification, and validation of analytical assays for the testing of clinical stage productsRan HPLC, SDS-PAGE, Container Closure, pH, Appearance, One-Stage Clotting (a parallel line assay), Chromogenic (a calorimetric assay), Particulate Matter and UV/vis spectro-photometric assaysSkilled in lab protocols in accordance with the ISO 9001 standard and GLP/GMP guidelinesSet up an organizational system saving analysts time searching for protocols and protected protocols from lab chemicals and contaminantsDepartmental presentations on analytical investigations, qualifications, and validationsIdentified basic technical problems and developed problem solving skillsAnalyzed and interpreted experimental results

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