melanie williams

senior technical, operations

About

Principal scientist and manager with significant biotechnology experience most recently emphasizing analytical method development and validation. Broad background in the drug development process from research to commercialization. * Biochemistry method development and validation with expertise in potency and immunoassays. * Significant experience with the design, performance, and presentation of CMC studies required for regulatory compliance. * Success in building and leading teams needed to attain drug development goals. Established close working relationship with members of Regulatory, Quality Control, and Quality Assurance to move basic research into the clinic. * Excellent oral and written communication skills. * Completed Regulatory Affairs (US) certification (RAC) 2008

Country

united states

City

raleigh

Industry

biotechnology

Skill

biotechnology, validation, biopharmaceuticals, biochemistry, analytical chemistry, immunoassays, gmp, lifesciences, fda, analytical development, sop development, regulatory

Experience

senior technical, operations

principal research scientist

grifols

2011-1 - 2013-1 · 2 yrs 1 mo

principal research scientist

talecris biotherapeutics, inc.

2006-1 - 2011-1 · 5 yrs 1 mo

director of analytical development

transkaryotic therapies

1994-1 - 2002-1 · 8 yrs 1 mo

senior technical , operations , and commercial liaison

bioagilytix

2013-9 - Present · 13 yrs 1 mo

BioAgilytix is a leading bioanalytical contract research organization (CRO) that supports the development of novel therapeutic biologics and biosimilars. Located in Research Triangle Park, North Carolina, BioAgilytix specializes in large-molecule bioanalysis providing critical insight into the safety, efficacy, and mechanism of action of drug candidates throughout the clinical trial process. Specifically, BioAgilytix offers assay development, validation, and sample analysis services for immunoassays and cell-based assays under non-GLP, spirit-of-GLP, and GLP, as well as product release testing under GMP. BioAgilytix is an engaged and energetic partner committed to delivering exceptional value and veteran expertise through a collaborative process that consistently results in successful projects.