"Your only limitation is the one you set-up in your own mind" Napoleon Hill - InspirationalSenior R&D Director with special interest in life threatening Infectious Diseases Dx, I am providing my proven multidisciplinary expertise in New Product Development, Industrialization and launch for IVDD & IVDR regulated and non regulated products to support Life Tech and diagnostic industries.----My motivations are really in living the present and like [Albert Einstein] said "Life is a preparation for the future; and the best preparation for the future is to live as if there were none." [Robert Greene] once suggested that we should "Understand: the future belongs to groups that are fluid, fast and nonlinear." and since [Keren Salmansohn] said that "No amount of regret can change the past and no amount of anxiety can change the future", I rather live in the present and just state that my strength lies solely in my tenacity [from Louis Pasteur - Ma force repose uniquement sur ma ténacité]
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Fondateur Et Consultant SéniorPsrd ConsultParis, Fr
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Senior ConsultantAction For Results Apr 2024 - PresentChelmsford, Ma, UsSenior Consultant, New Product Development -
Owner And Senior ConsultantPsrd Consult Nov 2023 - PresentSeasoned consultant in Life Sciences Product Research and Development. An integrator of various regulated R&D and production processes, I help my clients enhance value for both their customers and their businesses. Strong expertise in applying the phase-gate process in conjunction with iterative processes of design control, value-driven definition, agile/hybrid development, product and project risk management, and technical reviews. I help leaders and their teams thrive in the complex environment of regulated IVD product development by simplifying new product development processes.
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Global R&D Director – Assay Design Transfer & Industrialization.Bio-Rad Laboratories Apr 2021 - Jul 2023Hercules, Ca, Us- Operational and Functional Management of the Assay Design Transfer & Industrialization Activities for all Core Diagnostics Businesses (40+ FTEs, $ 10 mn budget (Switzerland (CH), Seattle (USA) and Lille (FR).- Lead on IVDD to IVDR global transition program for all infectious disease products (510K, PMAs, BLAs).- Covered fields include Molecular Biology, Microbiology, Antibiotic Susceptibility Testing, Immunoassays (Microplate Elisa, Bead based multiplex EIA on closed systems), LDTs, RUO.> Effectively implemented Global processes for efficient Assay Design Transfer activities at the Core Team level with Operational excellence KPIs (First pass yield, COGS targets, QN & TQNs targets etc.…) -
Intl R&D & Design Transfer Director - Infectious Diseases Business.Bio-Rad Laboratories Nov 2017 - Apr 2021Hercules, Ca, Us- Operational Management of the R&D and Assay Tech Transfer (TT) teams in Infectious Diseases (40+ FTEs $ 10 mn budget – 1site in France + 1 site in US) to ensure proper Development & transfer into manufacturing of new Assays and integrated Systems.- Technology evaluation and design review of early-stage solutions (IVD and Life Sciences) in Immuno-assays, Digital Molecular Testing, Digital Microbiology and AST, Point of Care and rapid testing solutions.- Proven track records in launching Products and Systems in the IVD field (510Ks, PMAs and BLAs).> Effectively launched HIV, HCV and Mycology tests (US and OUS) and first to launch of a Total Antibody Covid test (CE IVDD & FDA EUA) for early serological monitoring of immune response.
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Intl R&D Director - Infectious Disease Division (Idd).Bio-Rad Laboratories Mar 2013 - Nov 2017Hercules, Ca, UsIntl R&D Director in Infectious Diseases. - Operational Management of the R&D department in Infectious Diseases (100+ FTEs, $ 25 mn budget) with strong focus on infectious diseases testing in Blood banks and plasma centers.- Lead on IVDD to IVDR global program for all infectious disease products (510K, PMAs, BLAs).- Fields included Molecular Biology and sample prep, Microbiology and Antibiotic Susceptibility testing and Point of Care solutions for stand-alone and system solutions.> Effectively managed change in the organization from a business unit to a matrix model leading to consolidation of non-strategic program and re-orientation of skills toward more strategic programs.
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Intl R&D Manager - Clinical Microbiology Division (Cmd).Bio-Rad Laboratories Mar 2003 - Mar 2013Hercules, Ca, UsIntl R&D Manager - Clinical Microbiologyo Operational Management of R&D teams (30 FTEs, $ 10 mn budget) specialized in Clinical Microbiology and Immunoassays (510K).- Implementation of new ways / tools to increase R&D efficiency (lean R&D, Knowledge database, Agile software development process, Reinertsen Flow Product Development process & MVP).- Maintained technological awareness through IP and Technology analysis to define strategic orientation in IVD. Developed strategic partnerships with Academic Institutions, Private Companies & CMOs.> Supported the Business Unit top line from $ 30 mn to $ 120 mn based on organic NPD / NPI activities.
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Research And Development ManagerEurobio Mar 1997 - Feb 2003Les Ulis, Île-De-France, FrEurobio (Paris Area - November 1997 to March 2003) - Managed the R&D Unit (5 technical staff) to develop and launch a full range or veterinary IVD molecular tests – End point PCR and qPCR.- Elaborate marketing plans and launch books, perform internal training of sales force.- Develop technological transfer and/or co-development programs with academic institutions. > Developed, transferred, and registered an innovative media used for Human Corneal graft.Eurobio (Toulouse Area - March 1997 to November 1997)- In charge of performing a scientific & financial feasibility study to support the internal development of a new range of veterinary IDV products (Bovine abortion, Prion testing, Porcine respiratory diseases). > Succeeded in getting a € 1 mn Government funding (ANVAR) over a three-year period to support the Development and Launch a new veterinary line of products. -
Scientific Associate Director / Clinical Research.Cedibio Unilabs Dec 1992 - Nov 1996Toulouse, Occitanie, FrScientific Manager / Clinical Research (Molecular Biology, 3 people – Turnover € 1mn).- Developed, validated, and implemented various NAT tests in medical virology & bacteriology (LDTs).- Performed feasibility studies for all new development in NAT testing.Laboratory Manager (Specialized Biology, 14 people – Turnover € 1.8mn).- Managed the Molecular Diagnostic lab (HCV - HIV - HBV – H.pylori – C.T – Legionella – T.gondii).- Managed the Veterinary and Food control lab (L.mono – Salmonella spp – VTI & VTII).- Management of 14 FTE laboratory team in charge of specialized biology tests (RIA, HPLC, NAT).
Patrice Sarfati Education Details
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Université De SherbrookeBiology - Gastro-Intestinal Physiology -
Inserm - Institut National De La Santé Et De La Recherche MédicaleMolecular Biology And Gastro-Intestinal Cancer Research
Frequently Asked Questions about Patrice Sarfati
What company does Patrice Sarfati work for?
Patrice Sarfati works for Psrd Consult
What is Patrice Sarfati's role at the current company?
Patrice Sarfati's current role is Fondateur et Consultant Sénior.
What schools did Patrice Sarfati attend?
Patrice Sarfati attended Université De Sherbrooke, Inserm - Institut National De La Santé Et De La Recherche Médicale.
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