Seth Harkins Email and Phone Number

– Responsible for MSD’s entire development portfolio of protein biomarker assays that has included targetareas in cytokines, metabolic markers, neurodegeneration and immuno-oncology target groups.– Directed the 2020-2022 assay development program to establish and commercialize MSD’s multiplexedCOVID-19 Serology panels. These have rapidly become the standard for vaccine development and clinicaltrials thus establishing serology as a significant platform product for MSD.– Pioneered molecular assays at MSD with N-PLEX. Now working directly with pharmaceutical partners todevelop femtomolar PK assays for RNAi therapeutics (ASO, siRNA, amiRNA). Additionally developed a suiteand SARS-CoV-2 viral variants panels for lineage typing as a rapid alternative to sequencing.– Frequently managed custom assay development projects with pharmaceutical partners to establish solutionsunique to the needs of the therapeutic program.– Assembled and mentored a team of >40 managers and scientists to deliver on portfolio objectives.– Ongoing responsibility for the initiation of new assays working executive leadership to the strategic productdirection for the organization and Stage Gated product development thereafter.– Represent R&D in design control audits (ISO 13485 & 9001) as a senior member R&D management.

– Led new product development to create molecular controls in the precision medicine program [non-invasive prenatal testing (NIPT), ctDNA, cfDNA, and exosomes].– Successfully utilized ddPCR, qPCR, particle size analysis and Next Generation Sequencing (NGS) toadvance new product development initiatives for precision medicine applications.– Member of the integration team focusing on merging of KPL’s ISO 9001 registration with Seracare’sISO13485 registration, facilities renovation/buildout, design control processes, and ERPs.– Principal architect for the overhaul of Seracare’s design control process and the introduction of ideation NPD phase and the prototype commercialization program that allows rapid conversion of early proof of concepts to distributable product while conforming to our rigorous quality standards.

– Directed an R&D group to develop immunodetection tools in the areas immunoassay detection,inflammation, and microbial detection.– Revitalized the Bactrace product line through timely product introductions, including the suite of STECreagents, which resulted in the 100% growth of BacTrace catalog sales from 2011 to 2012. The BacTrace manufacturing process was also overhauled to support complete product traceability from finished antibody to the bacterial cultures (BSL2+).– Created and implemented the “Do-Sell” methodology for polyclonal antibody development which speedstime to market through batch-level traceability of antibody development from concept to commercialization.– As a member of senior management, contributed extensively to the due diligence and acquisition process from the selling company side by compiling technology and operational portfolios, customer/sales information, and licensing compendiums.– Initiated the relationship with Vivione Bioscience, LLC resulting in the strategic supply and development agreements to produce the kits and reagents for their diagnostic platform for bacterial detection.– Extensive experience with FourthShift ERP (focus on configuration engineering and product costing)

– Redesigned the production synthesis of the 2nd Generation Grubbs Ru metathesis catalyst resulting in the removal of two (net) manufacturing process steps.– Worked with in-house counsel to carryout synthetic and NMR investigations into the mechanism of 1stgeneration Grubbs catalyst formation to support a patent infringement case.– Completed daily discovery activities including: ruthenium metathesis catalyst synthesis, ligand synthesis, catalyst screening, catalyst application development and X-ray, GC-MS and NMR (1H, 31P, 13C) analysis of small molecules.

– Completed projects and published results on a variety of polyolefins resulting for organometallic catalysts.Award grants to support summer research– National Science Foundation REU Summer Research Grant, 1999– John & Elizabeth Holmes Teas Fellowship for Chemistry, 1998

– Completed projects on the pre-formulation of a therapeutic targeted for Rx to OTC switch and developed the synthetic methodology for the generation of stanol-esters to support an emerging nutraceutical line– Gained hands on experience with modern drug delivery, pre-formulation and physical pharmacy techniques and specialized training in reverse-phase HPLC of small molecules, modulated DSC, TGA, and scanning electron microscopy (SEM)