Michael Chi Email & Phone Number

Cambridge, MA, US

Boston, Massachusetts, United States

Cambridge, MA

• 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.

Woburn, MA

Woburn, MA

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.

Woburn, MA

Woburn, MA

• 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

Cambridge, MA

• 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

Leslie Griffith Lab

• 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

Master Of Business Administration - Mba

Master'S Degree, Biotechnology

Bachelor Of Science (B.S.), Highest Honors, Biology, General

High School