Associate Director, Analytical Sciences and Technology

With 20+ years of industry experience, I have demonstrated expertise in quality control and analytical science support for clinical and commercial manufacturing, for therapeutic monoclonal antibodies and proteins. My responsibilities have included overseeing and leading the validation and transfer of QC methods, conducting bridging, physiochemical characterization, and comparability studies. I have extensive knowledge of various analytical methods, such as HPLC, IEC, HIC, icIEF, CE, SEC, and safety tests. I have provided complete end-to-end customer solutions across a broad range of industries: manufacturing, utilities, pharma, food, etc.

I excel in generating, reviewing, and approving controlled and technical documents, such as test methods, stability protocols, validation reports, and characterization/comparability reports. I have demonstrated expertise in the design and authorship of test methods, analytical and process validation protocols/reports, technical transfer protocols, release and stability specifications, SOPs, root cause investigations, statistical trend analysis, change controls and CAPAs. I have maintained cGMP compliance in QC labs and cGMP training to staff members. Additionally, I have a proven track record in efficiently managing CRO and CMO projects related to analytical and QC testing. I have effective communication and collaboration skills to work with cross-functional teams and external vendors to meet aggressive timelines.