At GTP I am an analytical development and QC scientist in a GxP setting. SME and lead method developer for Mass Photometry and SEC-MALS. Responsible for initial method development, Pre-qualification, and tech transfer to GMP CDMO partner. Designed pre-qualification protocols to determine LOD/LOQ, range, accuracy, precision, and robustness according to ICH guidelines. -SME for AAV capsid content characterization (Mass Photometry, SEC-MALS, AUC), AAV titer (SEC-MALS), and AAV particle… Show more At GTP I am an analytical development and QC scientist in a GxP setting. SME and lead method developer for Mass Photometry and SEC-MALS. Responsible for initial method development, Pre-qualification, and tech transfer to GMP CDMO partner. Designed pre-qualification protocols to determine LOD/LOQ, range, accuracy, precision, and robustness according to ICH guidelines. -SME for AAV capsid content characterization (Mass Photometry, SEC-MALS, AUC), AAV titer (SEC-MALS), and AAV particle sizing/impurity assays (DLS, CE-SDS)-Primary author for SOPs and experienced with GDP practices (Revisions, Deviations) -Responsible for training analysts to perform GMP methods -Developed analytical scale AEX assay serving as predictive model for preparative scale AEX purifications and transferred technology to MS&T-Presented novel method and pre-qualification of GMP Mass Photometry method at Mass Photometry User Summit (May, 2024)-Lead multiple method development project simultaneously while also completing routine QC testing-Performed routine QC stability testing for appearance, pH, DLS, and osmolarity-Presented data to internally at team and company wide meetings Show less

-Independently supported various manufacturing departments via SEC-MALS analysis of in-process & drug product rAAV samples to provide guidance on best practices-Compare results with orthogonal methods to optimize alignment-Optimized SEC-MALS assay parameters such as column matrix, pore size, flow rate, mobile phase, and injection volume-Pre-qualified SEC-MALS method for transfer to QC (Linearity, Accuracy, Precision & inter. Precision)-Assisted and trained members of other… Show more -Independently supported various manufacturing departments via SEC-MALS analysis of in-process & drug product rAAV samples to provide guidance on best practices-Compare results with orthogonal methods to optimize alignment-Optimized SEC-MALS assay parameters such as column matrix, pore size, flow rate, mobile phase, and injection volume-Pre-qualified SEC-MALS method for transfer to QC (Linearity, Accuracy, Precision & inter. Precision)-Assisted and trained members of other teams install & perform their own SEC-UV instruments (Agilent & Wyatt) Show less

-Reagent development for LabType diagnostic assays in a GMP and GLP setting-Assay development, process optimization, and validation for FDA approved diagnostic assay-Addressing customer inquiries and optimizing reverse sequence-specific oligonucleotide (rSSO) methods-Primer/probe design, probe-bead conjugation, DNA amplification, Capillary electrophoresis, hybridization, and performance of the multiplex assay on Luminex100/200 & Luminex 3D instruments