Melissa Corso Minderman Email & Phone Number

Indianapolis, Indiana Area

 Developed ELISA and lateral flow assay (LFA) IVDs from feasibility to validation with team role of subject matter expert. Designed, executed, and summarized medical device characterization and stability studies following FDA and ISO 13485 guidance and standards. Led design control activities including verification, validation, tracking and trending, troubleshooting, and associated documentation. Authored training procedures and executed in-person clinical trial site training and monitoring. Monitoring included management of test data and applicable logs and forms. Ensured smooth technology transfer of IVD reagent quality control methods to in-house production organization. Created customer-facing documentation such as package inserts, SDS, and quick reference guides. Supervised one employee in IVD development activities. Led cross-functional team meetings and product risk activities including dFMEA. Provided support for internal and external audits, CAPA activities, and Quality Control inspections. Introduced to 510(k) process and provided technical documentation to support submission to FDA.

Indianapolis, Indiana Area

 Performed environmental testing in order to rapidly identify bacterial and viral public health threats. Executed and interpreted multiple real-time PCR (qPCR) assays to detect and characterize potential pathogens and ensure assay quality. Maintained chain of custody and sample integrity from DNA extraction through qPCR using aseptic BSL2 techniques. Summarized and reported findings into laboratory information management system (LIMS) daily for review.

Branford, Ct

 In a technical lead role, developed DNA sequencing kit for GS Junior, a benchtop next-generation (NGS) DNA sequencer. Supervised four direct reports within R&D department, focusing on reagent formulation, optimization, guardband, stability, vendor, and protocol improvement studies. Created and maintained a record of over 1000 GS Junior sequencing assays to trend and troubleshoot data throughout product development. Collaborated with Engineering and Reagent Manufacturing groups to improve hardware and consumable design. Created product development and manufacturing documents, including specifications, DFMEA, SOPs, and verification reports. Assisted technology transfer effort from Development to Manufacturing, Quality, Marketing and Customer Support organizations. Prepared presentations for multiple audiences and participated in cross-functional groups for CAPA and launch efforts. Coordinated 12 people in over 70 product validation assays, compiled results, and authored necessary documents to support an on-time product launch. Managed and analyzed over 500 assays supporting GS FLX Titanium Sequencing Kit optimization, stability, and verification. Performed and analyzed DNA sequencing experiments supporting feasibility and optimization of GS FLX next-generation DNA Sequencer and GS FLX Sequencing Kit. Executed, managed, and documented accelerated and real-time stability experiments for sequencing reagents and determined shelf life. As a first-user and subject matter expert, developed and delivered initial training of DNA sequencing protocols to R&D, Quality Control, and Customer Service groups.

New Haven, Ct

 Executed protocol for screening of proprietary peptide display library, resulting in the identification of potential anti-tumor peptide sequences. Developed Western and ELISA methods to study peptide mechanisms of action. Investigated over 30 anti-tumor peptides using cell-based assays. Optimized RT-PCR and affinity chromatography methods to investigate peptide mechanisms of action.

New Haven, Ct

 Performed proprietary Whole Genome Amplification service on customer samples, up to 200 samples per day. Determined sample quantity and quality using real-time PCR and compiled data into customer reports.

New Haven, Ct

 Prepared customer DNA samples for high-throughput sequencing and operated ABI 3700 DNA sequencer to process 400 samples per day. Executed quality control on products and maintained database of customer information and results.

New Haven, Ct

 Supported process development for purification of lead pharmaceutical candidate using anion, cation, and hydrophobic interaction chromatography. Performed Western analysis of purification products following GLP standards.

Bethesda, Md

 As a member of a prestigious undergraduate study group, performed molecular biology research for the National Institute of Dental Research.