Hamed Shadpour, Ph.D., Mba Email and Phone Number
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I am a seasoned business, technology, and innovation executive with an MBA and 20+ years of overall professional experience. Recognized for demonstrating a natural aptitude for R&D, engineering, and operations leadership. Professional focal points also include new product development (systems, consumables and assays), innovation and roadmap, program and project management, and regulatory compliance, as well as numerous facets of leadership and strategic planning excellence focusing on biotech, diagnostics, biopharma and life science applications. Key experience and qualifications are as follows: • Recognized for more than 20 years of hands-on experience in engineering, R&D, and manufacturing, focused on new product, process, and technology development under FDA, ISO, CE, EMA, ICH, and cGMP regulations.• Designed, developed, and launched over 150 innovative products, including 50+ FDA/CE-approved, award-winning, and top-selling products, as well as $10B+ production lines for diagnostic, biotech, pharma, and laboratory applications; led these projects from concept through prototyping, development, launch, manufacturing, and full product life cycle management.• Served 15+ years in leadership and management roles with P&L responsibilities, building and leading global cross-functional teams of 10 to 120+ engineers, scientists, and managers with diverse backgrounds and managing budgets ranging from $1M to $100M in both fast-paced, matrix structured startups and large corporations with $60B+ in revenue.• Functioned as a former startup founder, CSO, and CTO, responsible for making key decisions, influencing executives and KOLs, driving more than $500M in executed services, spinoffs, and M&As, and raising over $200M for fundraising and technology transfers.• Honored with the U.S. Medical Design Excellence Award for leading the development and launch of ePlex at GenMark Diagnostics, which became an industry benchmark and contributed to a $1.8B acquisition by Roche. • Distinguished subject matter expert within the scientific community, with over 100 patents, publications, invited lectures, and prestigious awards. Colleagues describe me as a progressive, experienced, and dynamic, team, business, and technical leadership expert who can be relied on to offer superior solutions that consistently deliver positive and exceptional results.My recent position at BioMEMS Solutions will be affected by company's upcoming site closure in California, and I am pursuing new leadership opportunities in the U.S. and can be reached through this profile.
Biomems Solutions
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- BioMEMSSolutions.com
- Employees:
- 1
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Biomems SolutionsSan Diego, Ca, Us
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Global Head Of R&D & EngineeringBiomems Solutions 2022 - Nov 2024• Oversee end-to-end product development and engineering, driving the design, prototyping, development, regulatory submissions, launch, and manufacturing of cutting-edge microfluidic-based devices and consumables with integrated assays and software platforms for laboratory, diagnostic, and biotech applications.• Lead and mentor a multidisciplinary team of systems, mechanical, electrical, biomedical and software engineers, scientists, and PMs, including managers and supervisors in San Diego and Orange County, while coordinating with over 100 SMEs and 15+ CDMOs and cleanroom facilities globally across 20+ active projects in a fast-paced, dynamic environment.• Responsible for boosting annual revenue 30% via the introduction of the company's proprietary 4MEMS product line; this included 5 benchtop instruments and over 12 consumable cartridges, assays, and kits for rapid, multiplexed biological sample processing and analysis.• Manage resource allocation, project prioritization, and oversee the planning, execution, and delivery of engineering projects, ensuring adherence to quality standards, timelines, and budget constraints. • Collaborate cross-functionally in compliance with FDA, EMA, and ISO/CE regulations while providing technical guidance and staying current with industry trends and emerging technologies.• Play a key role in strategic company planning, identifying new opportunities for business growth and innovation. • Assume accountability for continuously negotiating new engineering proposals and business agreements through site visits, resulting in a 25% increase in the value of assigned projects and expansion of the R&D department.
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Senior Director Of R&DHalma Plc 2021 - 2022Amersham, Buckinghamshire, Gb• Reported to the divisional CEO, leading global R&D and Engineering departments across the U.S. and Europe to expand the company’s product portfolio, driving $2.5B+ in revenue by introducing new laboratory and pharmaceutical applications and ensuring seamless transition of products from concept to production.• Assembled and managed a global team of systems, mechanical, electrical, biomedical and software engineers, chemists and biologists, alongside 12 partners and consultants from Halma companies, to develop, launch, and manufacture innovative products; these included benchtop and portable instruments, OEMs with smart sensors, and associated software platforms, assays, reagents, and consumables, following phase-gate review processes under ISO/CE, FDA, and EMA regulations.• Surpassed annual revenue targets by launching 11 new finished products—five ranked as global top sellers—with 14+ additional products in the pipeline, contributing $10M+ in annual sales. • Improved and sustained the performance of 200+ existing products, delivering $5M+ in annual savings and achieving the best financial year in the company’s 50-year history.• Overhauled the R&D and Engineering departments, managing an average of 25 work orders per month alongside major NPD projects, resulting in a 25% reduction in R&D and engineering work hours and delivering $4M+ in annual savings. -
Senior Director Of EngineeringAmberstone Biosciences 2018 - 2021Irvine, California, Us• Tasked with reporting directly to the CEO, leading R&D engineering and technical operations for the development, regulatory submissions, launch, and production of cutting-edge electro-mechanical and optical instruments, microfluidic consumables, integrated cell and immunoassays, along with associated software and reagents. • Focused on companion diagnostics (CDx), drug discovery, and immunotherapeutic cancer treatments in support of the company's groundbreaking T-MATE technology.• Invented, developed, and launched 6 models of AmberFlow systems (patented) along with 25+ assay cartridges, reagents, and kits within one year. • Recruited and mentored a team of systems, mechanical, electrical, biomedical and software engineers while initiating and maintaining business partnerships with key opinion leaders (KOLs) and major clients, including Roche and Amgen.• Streamlined the R&D/Engineering portfolio and operations via continuous process improvements such as DFSS, FEMA, and Lean methodologies, contributing to an average 25% CAGR in revenue growth. • Secured Phase I & II SBIR grants and raised $12M+ in Series A funding. -
Director Of Project & Program ManagementNitto Avecia 2016 - 2018Milford, Ma, Us• Led the company's initiatives in new product and process development (Rx, Combination Devices, and CDx), CMC, process and technology transfer, clinical trials, FDA submissions, and cGMP parenteral manufacturing and sterile fill/finish across five ISO and FDA-certified CDMO facilities located in CA, MA, OH, and Japan.• Functioned as head of the PMO and subject matter expert in a highly regulated industry, managed complex projects encompassing technical, budget, schedule, and KPIs, while coordinating cross-functional departments in a fast-paced CRDMO environment. • Drove over $500M in business across 65 projects from feasibility to commercial launch, partnering with 40+ companies, including Pfizer, Roche, Genentech and AbbVie, and successfully brought 28+ innovative new products to market with ISO and FDA approvals.• Directed the performance of a matrixed team of scientists, engineers, PMs and technicians across five global facilities, focusing on planning, implementation, operations, and evaluation of projects, revenue analysis, and budget and resource management activities. • Ascertained optimal turnaround time, quality, and profitability while maintained frequent communication with the Board, General Manager, and CEO. -
Principal Engineer, Nexgen LeadGenmark Diagnostics 2011 - 2016Carlsbad, Ca, Us• Initiated the NexGen program, and successfully led the development, FDA submissions, launch, and manufacturing of the ePlex system (rebranded as Cobas ePlex), the world’s first fully automated digital microfluidic-based IVD platform; this system was the winner of the 2017 Medical Design Excellence Award and one of the first and most utilized FDA-approved COVID rapid testing solutions during the pandemic, while leading global teams.• Worked under ISO 13485 and 14971 QSR, led the design, prototyping, development, regulatory submissions, launch, and manufacturing transfer of five models of the ePlex systems along with associated software solutions/apps. • Supervised development of eight types of fully integrated sample-to-answer microfluidic-based consumable assay cartridges (RP, COVID, BCID-GP, BCID-GN, FP, GI, HCV & CNS), resulting in 10 systems and assays receiving FDA 510(k) and CE approvals, with patents granted.• Recognized as the first employee of the NexGen department and recipient of the 2014 Top Innovation Award; initiating the program, building the team, and establishing key partnerships valued at more than $16M.• Exhibited exceptional leadership in expanding applications from DNA/RNA to immunoassays (in partnership with Perkin-Elmer) and sustaining the quality of 3 models of XT8 systems with 7 types of consumable assay cartridges (RP, HCV, CF, 2C19, TRT, 3A4/3A5 & Warfarin, all FDA/CE approved), resulting in over $3M in annual cost savings.• Spearheaded the R&D transfer to manufacturing in the U.S. and China by implementing lean methodologies, resulting in over 50% cost savings on consumables. -
Founder & Chief Technology Officer (Board Chair, 2012-2020)Scivendor, Inc. 2010 - 2011• Introduced and implemented innovative technology partnership models that resulted in the development of new businesses and products for the biotech, IVD, and pharma industries. Some partnerships resulted in spinoff companies and business acquisitions.• Built and led a world-class team of engineers and scientists from the ground up, ensuring top-notch performance and results. Provided step-by-step coaching for registered clients from early business and product development phase through launch and manufacturing.• Secured investments and established long-term business agreements with key customers. Doubled revenue and increased the size of the technology core team by 50% annually. Expanded operations by opening two new R&D divisions in the U.S. and Singapore. -
Additional ExperienceVarious Positions 1999 - 2006• Cell Microsystems, , Chapel Hill, NC, 2007-2010 | Product Development Lead• BioFluidica, San Diego, CA, 2006-2007 | Founding Scientist (Part-Time)• Center for Bio-Modular Multi-Scale Systems, Baton Rouge, LA, 2004-2006 | Head of Proteomics (Part-Time)• Center for Advanced Microstructures & Devices, Baton Rouge, LA, 2002-2006 | Microfabrication & Integration Lead (Part-Time)• Arya Chem (Acquired), Baton Rouge, LA, 2000-2004 | Founder & Chief Scientific Officer (CSO)• University of Guilan, 1999-2000 | Adjunct Professor of Chemistry
Hamed Shadpour, Ph.D., Mba Skills
Hamed Shadpour, Ph.D., Mba Education Details
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University Of North Carolina At Chapel HillPost-Doctorate -
Louisiana State UniversityPh.D.
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University At BuffaloMba
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Poytechnic UniversityMaster Of Science - Ms
Frequently Asked Questions about Hamed Shadpour, Ph.D., Mba
What company does Hamed Shadpour, Ph.D., Mba work for?
Hamed Shadpour, Ph.D., Mba works for Biomems Solutions
What is Hamed Shadpour, Ph.D., Mba's role at the current company?
Hamed Shadpour, Ph.D., Mba's current role is Technology, Innovation & Business Leader | Biotech, Diagnostics, Biopharma & Life Sciences.
What is Hamed Shadpour, Ph.D., Mba's email address?
Hamed Shadpour, Ph.D., Mba's email address is ha****@****kdx.com
What is Hamed Shadpour, Ph.D., Mba's direct phone number?
Hamed Shadpour, Ph.D., Mba's direct phone number is +122534*****
What schools did Hamed Shadpour, Ph.D., Mba attend?
Hamed Shadpour, Ph.D., Mba attended University Of North Carolina At Chapel Hill, Louisiana State University, University At Buffalo, Poytechnic University.
What skills is Hamed Shadpour, Ph.D., Mba known for?
Hamed Shadpour, Ph.D., Mba has skills like Stem Cells, Immunoassays, Lab On A Chip, Medical Device, Cell Biology, Systems Engineering, Executive Management, People Management, 510k, Hplc, Cgmp Manufacturing, Technology Roadmapping.
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