Hello

I have worked in private and public organizations in Cellular Therapy, both domestically and internationally. Working as a Quality, Regulatory, and Compliance consultant in a global consulting firm has been an amazingly satisfying experience.

 

I have achieved multiple zero (0) observations from State to FDA inspections and accreditation agencies assessments. My model is E2, which is Effective and Efficiency for process development.

 

My diverse work experience includes laboratory design and workflow, software evaluation, regulatory filings, developing strategic Quality plans for execution, developing validation and reports, benchmarking, and total quality management.

 

I hold an MBA from the University of Phoenix and an MA in Biological Sciences from Hunter College, and is Six Sigma Green Belt certified. My areas of Competencies include: Audits, Global Quality, Global Regulatory and Compliance, Quality Control, Environment Monitoring, Clean Rooms, Clinical, Trial Studies, Laboratory Design, Project Management, GxP, QMS, Validation, HIPPA, GDPR, Commercialization, and Strategic Planning in the Cell Therapy field.

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Papers

Unson, C.G., Wu, C. R., Jiang, Y., Yoo, B., Cheung, C. P., Sakmar, T. P., and Merrifield, R. B. (2002) Biochemistry 41: pp. 11795-11803. 

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Unson,C.G., Wu, C.R., Cheung, C. P., and Merrifield, R. B. (1998) J. Biol. Chem. 273 (17): pp. 10308-10312.

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Unson, C. G., Wu, C. R., Cheung, C. P., and Merrifield, R. B. (1996) in Peptides: Chemistry, Structure, and Biology (kaumaya, P. T. P., and Hodges, R. S., eds) Mayflower Scientific Ltd., pp. 360-3.

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