Steven Gross

Steven Gross Email and Phone Number

System Verification and Validation Scientist Lead @ Sebia Autoimmune & Infectious Diseases - USA
Ambler, PA, US
Steven Gross's Location
Ambler, Pennsylvania, United States, United States
Steven Gross's Contact Details
About Steven Gross

With over 20 years of experience in assay and product development for liquid biopsy, oncology diagnostics, and BioPharma applications, I've been a Project manager, project leader, and inventor for several companies that provide cell and molecular based diagnostic solutions. I've led and managed the design, verification, and transfer of novel fee-for-service biomarker assays to the clinical labs, utilizing the FDA-cleared CTC capture device Parsortix® system with immunofluorescent microscopy detection. I have successfully developed and implemented multiple BioPharma clinical assays, resulting in significant revenue generation for both R&D and Clinical Lab Services. I leverage my strong interpersonal skills to engage cross-functionally with R&D, Operations, Commercial, and Pharma customers, supporting diagnostic product development programs by contributing subject matter expertise and preparing required documents. I also have a track record of commercializing various RUO cell capture and detection kits for circulating tumor cells, endothelial cells, and melanoma cells using the CELLSEARCH® platform, and launching several customer-based cellular and molecular biomarker service products. I am passionate about advancing the field of liquid biopsy and oncology diagnostics, and delivering innovative solutions that meet the needs of the customers and the patients. I am a dynamic professional adept at leading, mentoring, and guiding teams in achieving targeted milestones. I have received multiple leadership awards and have authored several patents and publications in this domain.

Steven Gross's Current Company Details
Sebia Autoimmune & Infectious Diseases - USA

Sebia Autoimmune & Infectious Diseases - Usa

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System Verification and Validation Scientist Lead
Ambler, PA, US
Website:
sebia-ai-id.com
Employees:
16
Steven Gross Work Experience Details
  • Sebia Autoimmune & Infectious Diseases - Usa
    System Verification And Validation Scientist Lead
    Sebia Autoimmune & Infectious Diseases - Usa
    Ambler, Pa, Us
  • Sebia Autoimmune & Infectious Diseases - Usa
    System Verification & Validation Scientist Lead
    Sebia Autoimmune & Infectious Diseases - Usa Nov 2024 - Present
    Branchburg, New Jersey, United States
    • Managing the verification and validation processes for the development of innovative autoimmune and infectious disease IVD products.• Ensuring that reagent & instrument systems meet regulatory standards, function properly, and perform according to their analytical and clinical claims.
  • Gross Financial Services
    Director Of Marketing
    Gross Financial Services Aug 2024 - Nov 2024
    Feasterville-Trevose, Pennsylvania, United States
    • Sales & Marketing support for a range of insurance, investment, and wealth management products and services to improve customer's financial health.
  • Angle North America Inc
    Clinical Assay Development Manager
    Angle North America Inc 2021 - 2023
    Plymouth Meeting, Pennsylvania, United States
    • Project manager for British and US based R&D and Clinical Teams designing, verifying, and transferring novel fee-for service biomarker assays to the Clinical labs utilizing the FDA-cleared CTC capture device Parsortix® system with immunofluorescent microscopy detection.• Fee-for-service BioPharma clinical assays developed and implemented resulting in significant revenue generation for both R&D and Clinical Lab Services. • Leveraged strong interpersonal skills to engage cross-functionally with R&D, Operations, Commercial, and Pharma customers supporting diagnostic product development programs by contributing subject matter expertise required to prepare required documents such as manufacturing instructions, protocols, customer proposals, updates and reports, and marketing materials.
  • Menarini Silicon Biosystems
    Head Of Cellsearch Assay Development
    Menarini Silicon Biosystems 2017 - 2021
    Huntingdon Valley, Pa
    • Commercialized as Project manager a diagnostic blood based immunomagnetic RUO capture and detection kit for circulating multiple myeloma cells (CMMC) utilizing the FDA-cleared CTC capture and immunofluorescent detection platform CELLSEARCH® and DEPArrayTM technology for isolating single cell populations for cellular and molecular characterizations.• With a team of US and Italian based direct reports oversaw research, product support, fetal cell capture and detection, and phase-based product development for upgrades to both the CELLSEARCH® and DEPArrayTM diagnostic platforms.
  • Janssen Diagnostics/Janssen R&D, Pharmaceutical Companies Of Johnson And Johnson
    Senior Scientist - Oncology Biomarkers/Reagent, Assay, & Product Development
    Janssen Diagnostics/Janssen R&D, Pharmaceutical Companies Of Johnson And Johnson 2008 - 2017
    Huntingdon Valley, Pennsylvania, United States
    • Commercialized a variety of RUO cell capture and detection kits for circulating tumor cells (CTC), endothelial cells (CEC) and melanoma cells (CMC) using the CELLSEARCH® platform.• Launched more than half a dozen customer-based cellular and molecular biomarker service products with the Clinical Research Solutions business unit resulting in a multimillion-dollar revenue pipeline.• Supported commercialization goals by preparing and presenting final reports to customers and authoring and reviewing internal design control documents. • Presented at several scientific conferences and participated with Sales and Marketing at company booths.
  • Immunicon Corporation
    Senior Scientist - Reagent Product Development
    Immunicon Corporation 2000 - 2008
    Huntingdon Valley, Pa
    • Commercialized IVD/RUO rare cell capture and detection kits; and cell-based assays along with counterparts in the Netherlands for the detection of CTC with cellular biomarkers for use in pharmaceutical and clinical research in conjunction with CELLSEARCH®. • Integration, development, and commercial launch of a fluorescent-based assay for cell counting and viability determination – EasyCountTM & ViasureTM .• Project leader responsible for the development and integration of an assay for the pre-processing of large volumes of blood with engineering prototypes for use with CELLSEARCH®.

Steven Gross Skills

Biotechnology Cell Culture Cell Biology Oncology Pharmaceutical Industry Medical Devices Flow Cytometry Immunofluorescence Project Management Assay Development Technical Support Sales Support

Steven Gross Education Details

Frequently Asked Questions about Steven Gross

What company does Steven Gross work for?

Steven Gross works for Sebia Autoimmune & Infectious Diseases - Usa

What is Steven Gross's role at the current company?

Steven Gross's current role is System Verification and Validation Scientist Lead.

What is Steven Gross's email address?

Steven Gross's email address is st****@****hoo.com

What schools did Steven Gross attend?

Steven Gross attended Temple University, University Of The Sciences In Philadelphia.

What skills is Steven Gross known for?

Steven Gross has skills like Biotechnology, Cell Culture, Cell Biology, Oncology, Pharmaceutical Industry, Medical Devices, Flow Cytometry, Immunofluorescence, Project Management, Assay Development, Technical Support, Sales Support.

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