Marthe Berard-Bergery Email & Phone Number

California, United States

o Lead technical transfer from Process/Product Development to Operations (CLIA lab) of new product (ex: NeXT Personal), new processes and improved/automated processes. Plan with the stakeholders the required tech transfer activities, timelines, and resources, based on company goals. Coordinate cross-functional teams to ensure creation and/or update of the SOPs and product level documentation, reagent/consumable part numbers and specifications, LIMS programming, equipment maintenance, calibration, and qualification, as well as successful execution of validation and training. Track progress, raise issues or delays, and propose solutions. o Manage one Sr. Tech. Transfer Associate Scientist and two Sr Tech. Transfer Research Associates. o My team facilitated the release of three new RUO products, QIAsymphony for automated DNA extraction, and seven automated methods on Hamilton STAR liquid handling systems, with LIMS full integration when applicable, to replace manual processes for quantification, normalization, library preparation and pooling for sequencing.

Menlo Park, California, United States

o Identified gaps in company product/process implementation, created and built the tech transfer function to facilitate integration into Operations (CLIA lab). Created spreadsheets and diagrams to improve impact and risk assessments of new product/process implementation. Authored SOPs, templates, training presentations and JIRA projects to coordinate cross-functional team efforts and accelerate release.o Managed one Sr. Tech. Transfer Associate Scientist.

Menlo Park, California, United States

o Initiated development of NeXT Liquid Biopsy product after completion of feasibility by R&D. Assessed what new equipment, reagents, consumables, documents would be required. Planned execution of the development phase and trained scientist hired to take over the project after my transition to the Tech. Transfer role.o Lead development activities, equipment qualification, process validation and implementation of DNA and RNA extraction process from fresh frozen specimens using QIAcube.

Pleasanton, Ca

o Developed companion diagnostic tests utilizing Ion Torrent PGM Dx platform and reagents. Lead analytical validation studies, requiring drafting of protocols and reports, organization of daily activities for up to four employees, analysis of data, and presentation of design/technical reviews. o Member of team bringing R&D labs in compliance with site’s QMS and ISO13485 standards. Leading equipment validation effort requiring writing and reviewing of SOPs and IQOQPQ protocols/reports.o Co-developed RT-qPCR and NGS gene expression clinical trial assays (CTA) as part of a Pharma partner’s Immuno-Oncology program. Optimized DNA/RNA extraction and purification from FFPE samples, RT and amplification reaction set-ups using DOE methodology (JMP statistical software). Planned and executed development studies to set CTA test performance specifications and benchmarked performance of CTA’s to competing detection technologies.o Transferred fully characterized CTA’s to CLIA labs. Reviewed validation protocols and results, assisted in troubleshooting activities, edited CLIA lab SOP’s, and trained CLIA lab operators. CTA quantifying gene expression levels in gastric cancer samples received New York State CLEP approval.

Fremont, Ca

o Managed team of three Product Development Research Associates/Manufacturing Engineers for company focused on development of lateral flow test for detection of HPV E6 oncoprotein in cervical tissue samples (CE-marked OncoE6™ Cervical Test). o Set-up GMP manufacturing laboratory after company-wide move to new location in compliance to company’s QMS and 21CFR820 requirements. Additional activities included lab configuration, revision of documentation, and overview of IQOQPQ’s for all equipment.o Planned implementation of more cost-effective production including redesign of packaging to reduce raw material and shipping costs and in-house drying of kit components (versus lypholization of products by CMO). o Development of OncoE6 Cervical Test towards use for more specimens collection formato Implementation and supervision of GMP manufacturing of EUA-FDA approved diagnostic test for Influenza A/H7N9

Fremont, California

R&D core team member for CE-marked OncoE6 Cervical Test:o Clinical Studies Coordinator: FRIDA clinical study preparation, on-site laboratory set up and staff training in Mexico. Preparation of clinical trial in China for registration with CFDA. o Key member of team directing and overseeing the transfer of the lateral-flow-based product from development to operation: writing, review and approval of documentation: Manufacturing procedures, IQ/OQ/PQs, batch records required for transfer to CMO, protocols and reports.o Management of timelines and documentation needed for validation.o Participation in verification and validation studies for equipment and manufacturing processes.o FMEA, risk analysis and setting up cost of goods with supply chain, finance, manufacturing and product development.o Optimization and set up GMP production of cancerous cell lysates to use as QC analyte (improvement of cell culture process robustness, creation of cell banks, MFI writing).o Supervision of one full-time Senior Research Associate.o Oral presentation of the product clinical performance at 2013 EUROGIN conference in Florence, Italy.Project Manager for the development of a test for Influenza A/H7N9 in Lateral Flow Assay format:o Lead scientist on prototype optimization: cell culture and transfection to use as analyte model, lysis buffer formulation using DOE, workflow and packaging optimization. Supervision of the work on detection system (Gold-Conjugated mAbs) and cassette creation (thin-layer chromatography).o Coordination of the 9-member multifunction team for test development and manufacturing/QC setup.o Management of timelines and documentation needed for EUA submission to FDA.

Fremont, California

R&D core team member for product development of the AV AVantage HPV E6 Test:o Setup and execution of real-time and accelerated stability studies of the test components (Lateral Flow Assay); stability data review and generation of reports.o Contribution to user FMEA.o Test optimization toward use in low-resource settings (no-cold chain or complex equipment) by clinical technician with little to no experience: design of packaging, test platforms and stands, visual interpretation guide and user manuals; guard-bands studies for workflow optimization (Lateral Flow Assay).o Supervision of one full-time Research Associate.Clinical Study Coordinator (START-UP study):o Planning, writing of SOP and execution of clinical test production.o Training procedures and documentation preparation; optimization of lyophilized protein-based training analyte (Bradford, ELISA, Western Blot, Lateral Flow Assay, small scale in-house Lyophilization).o On-site laboratory set up and staff training in different sites in rural china.o Data analysis and publication review.

Sunnyvale, California

R&D core team member for the development of the new prototype in Lateral Flow assay format for the E6 based rapid diagnostic test for cervical pre-cancer and cancer – AV AVantage HPV E6 test:o Detection system optimization: mAb screening by ELISA, Western Blot and Lateral Flow assay, mAb gold-conjugation, enzymatic mAb-conjugation, detector reagent formulation and lyophilization.o Clinical specimens processing optimization: setup of a model using cancerous cell lines and human clinical specimens, lysis buffer formulation and workflow development (Cell culture, Lateral Flow Assay and HPV typing of clinical specimens by qPCR).o Execution of clinical feasibility study using specimens from patients with pre-cancerous or cancerous lesions; data analysis and publication review.o Training and supervision of Research Associate Interns for twice 8 monthsPreparation and participation in a clinical study in India and China:o Training procedure and documents preparation.o On-site laboratory set up and staff training in India. o Test of human clinical samples and data analysis during the study in India (July 2007).Set up of stable cell lines transfected with HPV E6 protein:o Plasmid creation and preparation: PCR, cloning, miniprep, maxiprep and DNA extraction.o Eukaryotic cells transfection, selection, cloning and screening by ELISA and Western Blot.

Sunnyvale, California

Monoclonal antibody development and production against E6 proteins from high risk HPV:o Sera screening, hybridoma fusion, cloning and culture.o Monoclonal antibodies production, purification and screening by ELISA and Western Blot.

Engineer In Biotechnology, Tri-National French, German And Swiss Degree, Specialization In Molecular And Cellular Biology, Graduated With Honors

Master Of Science (M.S.), Cellular & Molecular Biology, Specialization In Biotechnology, Graduated With Honors