• Managed external contract organizations by overseeing the qualification, transfer, and validation activities.• Authored, reviewed and approved phase-appropriate test method validation protocols and reports.• Supported cGMP operations, including technical review of change controls, corrective actions/preventative actions, deviations, OOS and other investigations or assay troubleshooting• Carried out life cycle management of analytical methods.

WILMINGTON, Mass.--(BUSINESS WIRE)--Jun. 27, 2016--Charles River Laboratories International, Inc. (NYSE: CRL) today announced that it has acquired Blue Stream Laboratories, Inc. Combining Blue Stream with Charles River’s existing discovery, safety assessment, and biologics capabilities creates a leading provider with the ability to support biologic and biosimilar development from characterization through clinical testing and commercialization.

• Developed bioanalytical methods and provided bioanalytical services (cGMP and R&D) to clients in biotechnology and pharmaceutical industry in support of product characterization, lot release, stability, and PK studies.• Conducted routine testing (cGMP and non-GMP) using LC-MS (Intact Mass Analysis, Analyte Quantitation, Peptide Mapping, N-Glycan Characterization)• Participated in the qualification/validation of GXP analytical methods• Developed and enforced EHS chemical safety procedures in compliance with government regulations for the laboratory and office area

• Designed and implemented systems to support cGMP and ICH compliance• Contributed in the development and improvement of quality standards for operations systems• Reviewed and established quality system processes and procedures that were in compliance with all required standards

• Published an independent research project on varying levels of social enrichment in the developmental phase (larval phase) in Drosophila melanogaster and its effect on their sleep behavior as adult flies• Performed experiments with postdoctoral supervisor on the effects of knocking down tim and per genes with RNAi and its effect on the circadian rhythm in Drosophila• Guided new postdoctoral researcher through the processes of various behavioral assays including sleep studies and larval density experiments