Miriam Nuffer Email & Phone Number

Raleigh, Nc, Us

Key work includes:* Expansion of the molecular platform to include differential diagnosis of multiple respiratory pathogens.* Integration of on-board sample preparation to minimize hands-on time, while maintaining rapid time-to-result.* Root cause analyses to improve product performance.* Design of experiments (DOEs) to optimize assay performance.* Preparing analytical verification protocols suitable for execution and regulatory filings.Non-technical leadership includes:* Recruited and mentored a team of junior scientists and engineers* Served on hiring teams for positions across departments (scientists, engineers, project managers, regulatory) and among levels, ranging from individual contributors to senior leadership.* Founding and long-standing member of the company’s culture and wellness committee, spearheading initiatives to foster employee engagement and enhance job satisfaction.* Served as company’s first chemical safety officer and authored chemical safety manual and training materials.

Development of the company's first platform level molecular (RT-PCR) test for diagnosis of SARS-CoV-2 under emergency use

Systems integration lead for the Finder G6PD test.Led integration activities from early stage development through FDA 510(k) clearance. Key work included: assay and fluidic protocol optimization, analytical verification studies, and reports for regulatory filings.http://baebies.com/products/finder/Lead scientist on various improvement projects to increase customer satisfaction and adoption of newborn screening product line.

Developed and optimized enzymatic activity assays from dried blood spots and whole blood. Projects ranged from early stage feasibility to late stage development and validation. Experience as core team leader and core team representative for both assay development and systems integration.

Verification and Validation:• Translated Illumina library preparation workflows for next generation sequencing onto a digital microfluidic system as part of a multi-site, cross-functional team that led to the launch of the TruSeq stranded mRNA protocol for the NeoPrep platform.• Performed system verification and validation of the Mondrian workstation and open platform cartridge to support the launch of the product, which generated over $1M in sales.• Executed root cause analysis of cartridge and instrument failure modes and implemented solutions as a Six-Sigma team member.Discovery and Feasibility:• Evaluated the design of a sample-to-sequence digital microfluidic cartridge and integrated sample preparation, PCR, template preparation, and pyrosequencing to identify lengths of short tandem repeats (STRs) and fungal pathogens.• Optimized reagent formulations of a 3-enzyme pyrosequencing system to increase read length from 20 bases to 100 bases on a digital microfluidic platform.• Collaborated with J. Craig Venter Institute as lead scientist to translate a gene assembly process, including Gibson assembly, PCR, and enzymatic error correction, onto the digital microfluidic platform and achieved an error rate equivalent to the bench top process. Other Accomplishments:• Wrote monthly and semi-annual reports and presented during site visits that contributed to over $2M in research funding from NIH and Department of Homeland Security.• Trained new employees and colleagues on developing, performing, and analyzing biological assays on the digital microfluidic system.

• Developed novel photopolymerizable silica sol-gel monoliths for use in microchip electrochromatography by optimizing sol-gel chemistry and ligand immobilization methods.• Characterized the effects of porogen, monomer, salt additives, and channel dimensions on the resulting monolithic structure using SEM, TGA, and DSC.• Designed and evaluated microfluidic sol-gel monolith-based systems for separation of glycosylated proteins and peptides from complex mixtures.• Fabricated microfluidic devices using soft lithography techniques.• Implemented fluorescence and mass spectrometry-based detection methods.

Ph. D

B.S.