Kerry White
About
Kerry White is from Framingham, Massachusetts, United States. Kerry works in the following industries: "Biotechnology". Kerry is currently Senior Lead Manufacturing Investigator II at Shire Human Genetic Therapies Inc, located in Cambridge, Massachusetts. In Kerry's previous role as a Associate Director CMC Development at EPIRUS Biopharmaceuticals, Kerry worked in Greater Boston Area until Nov 2015. Prior to joining EPIRUS Biopharmaceuticals, Kerry was a Senior Scientist at Genzyme sanofi and held the position of Senior Scientist. Prior to that, Kerry was a Senior Associate Scientist at Creative BioMolecules from Jan 1993 to Jan 1999. Kerry started working as Associate Scientst at Creative Biomolecules in Jan 1992. From Jan 1987 to Jan 1992, Kerry was Research Associate at Creative Biomolecules, based in Hopkinton, MA.
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Kerry White's current jobs
Lead cross-functional investigation teams to identify root cause, evaluate technical impact, and provide recommendations to management on batch disposition. Work cross-functionally to assess and analyze highly technical, complex, high impact deviations and investigations to determine impact and root cause. Identify and initiate corrective and preventive actions for deviations. Track and identify Quality System and root cause trends and identify opportunities for operational improvements.
Kerry White's past jobs
Lead development of integrated CMC plans and ensure integrated CMC plan execution across technical areas (Process Development, Analytical Development, Product Characterization, QC/QA/GMP Compliance)
Process Development: Provided process development and manufacturing support for recombinant proteins. Technical support for bulk manufacturing, including examining process performance, identifying process improvement opportunities. Designed, executed, and analyzed process robustness studies using QbD principles and JMP statistical software. Manufacturing Support: Performed troubleshooting for process problems, trended process and product parameters, reviewed production records, and trained operators on chromatographic theory. Performed scale down model development and qualification. CMC and Technology Transfer: Provided technical support to regulatory filings, inspections, and lot disposition. Served as team member which authored Process Control Strategy for an existing commercial product. Assisted in process transfer to CMO. Process Validation: Plan and direct viral clearance studies. Input into the design and interpretation of process validation studies.
Developed protein purification processes with scale-up from bench to pilot scale. Developed methods for the biophysical characterization of purified proteins. Validated purification process to support pre-market application and prepare for PMA inspection. Assisted in technology transfer from research to manufacturing. Developed and qualified assays for residuals in proteins and methods to support product release testing.