Associated Scientist_ Protein formulation and drug product development 2017 - present Shire Provided formulation and process development support for two injectable monoclonal antibody drug product development programs. Designed executed and communicated results of formulation robustness study pH range study PS80 range study. * Executed and communicated results of stability and comparability studies including evaluation of drug product stability in prefilled syringe candidates and glass vials confirmatory photostability in-use stability study of drug product with administration kit components and in-process contact material compatibility. * Support process development lab to determine suitable process parameters by evaluation of the impact of processing on product quality. * Support regulatory application and prepared documents for IND and BLA for clinical and late stage drug product development.

Highlights:

• Cancer
• Manufacturing
• Packaging
• Product Development
• Integrate
• Quality
• Quality Assurance
• Test
• Assessments
• Pharmaceutical