Wendy Wong Email and Phone Number
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I am a global leader with over 20 years of experience in bringing innovative molecular diagnostic solutions (infectious disease & oncology) to market driven by the passion to 1) make an impact on patient management/care, 2) build up diverse and high performing teams and 3) making things happen. I've held various leadership positions at Cepheid including the Vice President of Program Management, Vice President of Product & Program Management for the Software, Digital & Connectivity Business Unit, Vice President of Assay Development and most recently Vice President of Portfolio Management. Each role utilizing my vast experience in product development, deep understanding of the assays, software and hardware, team structure & delivery engine, and bringing strategy to action. I've spent over 20 years at Cepheid growing from a bench level scientist from before the company was profitable and had any diagnostics products on market to delivering ~50 products to market and at its peak $4 billion in revenues. My proudest accomplishment is delivering the COVID EUA test to market in less than 50 days which is the fastest time to market for Cepheid to date.
Melio
View- Website:
- melio.tech
- Employees:
- 31
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MelioCalifornia, United States
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Vice President, Portfolio Management OfficeCepheid Dec 2023 - Apr 2024Sunnyvale, Ca, Us- Oversee Cepheid's entire global new product development portfolio across innovation, assay development, engineering (Hardware & Software), market expansion, and product lifecycle.- Responsible for product development roadmap including on time product delivery, resource management, and portfolio capacity. -
Vice President, Assay R&DCepheid Jan 2023 - Dec 2023Sunnyvale, Ca, UsManage global assay R&D teams to develop & deliver best in class molecular diagnostic tests for infectious diseases and oncology.
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Vice President, Product Management & PmoCepheid Jan 2022 - Dec 2022Sunnyvale, Ca, Us- Oversee product and program management for the Software, Digital, and Connectivity Business Unit- Determine software/connectivity business strategy and develop product roadmaps to fit customer needs- Drive on time delivery of programs to support commercial assays and drive connectivity solutions.
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Vice President Program ManagementCepheid Jul 2020 - Jan 2022Sunnyvale, Ca, Us
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Head Of Pmo, Senior Director Program ManagementCepheid Sep 2018 - Jul 2020Sunnyvale, Ca, Us- Responsible for governance and execution for entire NPD portfolio for assays (infectious disease & oncology), software, and instrument platforms- Responsible for leading cross-functional team to bring SARS-CoV-2 EUA & CE-IVD products to market in record time.
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Senior Director, Oncology DevelopmentCepheid Aug 2016 - Sep 2018Sunnyvale, Ca, Us- Responsible for bringing oncology product development projects to market in hematology and solid tumors such as Breast Cancer- Successfully launched 3 CE-IVD products, Bladder Cancer Monitor, Bladder Cancer Detection, and Breast Cancer STRAT4- Oversee laboratory operations & management including budget, lab facilities, biosafety, equipment, and lab SOPs. - Directly manage a team of ~15 scientists including other project technical leads- Develop department project budgets and resource allocations in support- Department representative for cross functional teams including software, consumables engineering, failure investigation, product/process improvements, and material review board.- Ultilize Visual Project Mangement tools to define project scope, develop project timelines, identifiy project risks, and project issues.- Created standard work to define the requirements for Technical Feasibility and Design and Development.
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Director, Oncology DevelopmentCepheid May 2013 - Aug 2016Sunnyvale, Ca, Us- Direct and manage Cepheid's entire oncology product development portfolio.- Manage resource allocations for each of the oncology project teams.- Technical Lead for the Breast Cancer STRAT4 Assay. Developed product from concept phase through product launch. - Support for multiple Breast Cancer STRAT4 collaborations.- Collaborate with OHSU to develop a 20-gene Breast Cancer Signature for Recurrence on the GeneXpert platform.- Defined and created an RUO pathway for oncology product development.- Manage collaboration with MMQCI to develop secondary standards tied to the WHO for BCR-ABL.- Successfully CE-IVD launched Xpert BCR-ABL Ultra for deep monitoring with IS standardization to the WHO.
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Senior Development ManagerCepheid May 2010 - May 2013Sunnyvale, Ca, Us- Manage project collaborations with an external partner for the development of an FDA-Cleared BCR-ABL Monitoring Assay.- Manage a team of six scientists to develop and bring to market a more sensitive and accurate BCR-ABL Monitoring assay that can detect a 4.5 log reduction in BCR-ABL.- Prepare monthly updates to collaborators on project status and identify critical path items that impact the timeline.- Prepare weekly updates on project status to the executive team.
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Development ManagerCepheid May 2006 - May 2010Sunnyvale, Ca, Us•Developed and brought to market a 2009 H1N1 Flu Assay in less than 4 months. Product launched as a CE-IVD product and EUA product for US.•Completed 4 product improvement projects within one year and met aggressive timelines to prevent product from being backordered.•Developed and brought to market the company’s first CE-IVD & FDA Cleared genotyping assay (FII/FV)•Developed and incorporated a novel concept for isolation of DNA from whole blood using filter capture•Developed the company’s fastest time to result assay of 33 minutes (Sample Preparation & Detection)•Managed product development timelines by anticipating and remedying any issues that would severly impact the timeline.•Managed relationships with product development partners. Presented monthly and quarterly project updates. •Managed a team of three scienists responsible for developing genotyping assays with short time to results. Maintained their training files.
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ScientistCepheid May 2005 - May 2006Sunnyvale, Ca, UsResponsible for being an integral part of a team developing real-time PCR based IVD products that will enter the FDA approval process. I was a hands-on, bench level scientist with key responsibilities in the area of real-time PCR assays. Additionally, I was involved in all aspects of assay development including design of nucleic acid isolation methods from different sample types, design of highly multiplexed, real-time PCR and RT-PCR assays, creating and validating test methods, and systems integration.•Presented monthly project updates to the executive team•Worked closely with project managers to set schedules and timelines for product development•Technical lead that helped develop and bring to market a single tube reaction tube for a 2-step RT-PCR or Nested PCR assay
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Associate ScientistCepheid May 2003 - May 2005Sunnyvale, Ca, Us•Integrated automated RNA isolation from whole blood with a Nested RT-PCR bcr-abl duplex assay using the GeneXpert•Established Technical Feasibility of the bcr-abl GeneXpert assay•Evaluated and optimized sample preparation buffer formulations, volumes, and fluidcs.•Developed the first nested RT-PCR assay on the GeneXpert•Evaluated and optimized different cartridge configurations for optimal RNA isolation
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Research Associate IiiCepheid Oct 2001 - May 2003Sunnyvale, Ca, Us•Developed multiple sample preparation protocols including: the isolation of RNA from leukemic cells in whole blood, the isolation of viral RNA from cerebral spinal fluid, and the isolation of bio-threat organisms from sheep’s blood•Developed an automated RNA Isolation method from frozen tissue X-sections and cancer cell lines with the GeneXpert
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Research AssociateMedimmune May 2000 - Sep 2001Gaithersburg, Maryland, Us•Worked on the development of genotyping assays for influenza using RFLP and SSCP•Performed viral RNA isolations, optimiziation of RT-PCR conditions, primer analysis, restriction enzyme digests and fragment anaylsis•Qualified to perform RFLP and SSCP Genotyping Assay•Quantitative RT-PCR analysis using ABI 7700 including multiplex detection optimization with Taqman Probes•Examined the use of two different cell lines for growth of virus through the use of a biorobotic system and ABI 7700•Trained group members on the use of the biorobotic station (Qiagen Biorobot 9604) and wrote protocols•GMP Certified -
Laboratory AssistantUniversity Of California, Berkeley Jan 1999 - May 2000Berkeley, Ca, UsWorked with Dr. Richard Mathies' DNA high-speed/high-throughput DNA sequencing on microchips group. It incorporated the use of fragment sized fluorescently labeled DNA that is detected on a confocal laser system•Designed, laid out, and microfabricated capillary array electrophoresis microplates for DNA analysis•Synthesized and purified energy-transfer primers and ET cassettes•Improved and optimized bonding procedure for glass to glass substrates•Maintained and purchased lab and chemical supplies
Wendy Wong Skills
Wendy Wong Education Details
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Harvard Business School OnlineOther; Core Credential Of Readiness -
University Of California, BerkeleyChemistry
Frequently Asked Questions about Wendy Wong
What company does Wendy Wong work for?
Wendy Wong works for Melio
What is Wendy Wong's role at the current company?
Wendy Wong's current role is Program & Portfolio Management Executive | Strategic Product Development | Research & Development | Project Management | Molecular Diagnostics.
What is Wendy Wong's email address?
Wendy Wong's email address is ww****@****hoo.com
What is Wendy Wong's direct phone number?
Wendy Wong's direct phone number is (408)-541*****
What schools did Wendy Wong attend?
Wendy Wong attended Harvard Business School Online, University Of California, Berkeley.
What skills is Wendy Wong known for?
Wendy Wong has skills like Assay Development, Biotechnology, Polymerase Chain Reaction, Real Time Polymerase Chain Reaction, Reverse Transcription Polymerase Chain Reaction, Gmp, Dna, Rna Isolation, Oncology, Medical Devices, U.s. Food And Drug Administration, Validation.
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