Amber Hamlett (Blake) Email & Phone Number

Durham, Nc

- Developed and validated a ddPCR based method for the detection of mycoplasma contamination in client samples and in-house mammalian cell cultures- Onboarded Bio-Rad ddPCR, SCIEX CE, and Wyatt SEC-MALS instruments and related workflowsAuthored SOPs, Work Instructions, and training modules to support new instruments-Uses ICH guidelines, USP monographs, and European Pharmacopoeia monographs to develop andauthor validation protocols for test methods to support clients of all phases- Develops test methods, executes GMP validations, and authors associated reports to support client programs- Uses MasterControl to collaborate on documents, Trackwise to manage quality events, and BMRAM to log instrument maintenance activities- Interfaces with management and clients to report on project updates and status- Performs routine stability and release testing

- Assisted in the development and GMP validation of analytical methods to support client programs using techniques such as ELISA, total protein Bradford, and UV-Vis analysis- Collaborated on SOPs, Validation Protocols, Reports, and Test Methods using MasterControl- Performed routine stability and release testing to support client programs- Maintained 6S laboratory spaces, and participated in cleaning and organizational initiatives to increase lab workflow efficiency- Utilized LIMS to track reagents, samples, and test results

- Assisted in the development and cGMP validation of analytical methods to support formulation drugdevelopment for topical products- Performed routine testing, including stability testing, solubility studies, forced degradation studies,Drug-Excipient Compatibility studies and other activities to support method development- Used Empower 3 for HPLC sample analysis, data processing, and creation of data packs for reporting- Executed routine troubleshooting of Agilent and Waters HPLC instruments

Pensacola, Florida

- Prepared water, soil, and waste samples analysis by EPA methods 8260, 624, and 5030 to analyzesamples for volatile organic compounds- Operated multiple GC/MS instruments daily to support clients and prioritized work to meet client and/or project specific needs and deadlines- Utilized LIMS to record, analyze, and report results