christine manges

Determine bulk drug to be packaged for clinical trials, assign/update expiration dating, coordinate re-evaluation testing, coordinate stability studies, plan new manufactures of bulk drug, and inventory management.

* In-process bulk reagent testing/optimization * Final release reagent, calibrator, and control testing * Support Product/Instrument site transfer activities

* Develop micro-particle based immunoassays for Therapeutic Drug Monitoring * Design and perform experiments to develop and validate immunoassays * Analyze data and write summary reports * Polyclonal antibody screening * Small and large scale product manufacturing * Draft Manufacturing and Quality Control work instructions * Provide post launch product support * External clinical lab training * GMP Officer in charge of maintaining compliance of the instrument labs * Maintain inventory of laboratory supplies * Review monthly instrument maintenance logs

* Stability Product Leader in charge of maintaining on market stability program * Monitor stability studies by creating stability packets and testing schedules, ordering material, and entering data * Corrective and Preventative Action (CAPA) writer/approver * FDA Audit preparation for the launch of assays

* Execute and summarize external complaint investigations and stability test points * Maintenance, testing, and troubleshooting on the Architect instrument * Structured on the Job Trainer * Review stability paperwork for completeness and accuracy * GMP Officer in charge of maintaining compliance of the instrument labs * Work with Technical Support, Product Quality, and Analytical Quality to perform investigations

Activities and Societies: Alpha Chi Sigma