Weiming Shen

Experience

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  Department of Pharmacology, University of Colorado Health Sciences Center

  Mar 1997 - Sept 1999

  Professional Research Assistant

  Role and Responsibilities • Conducted human breast cancer research experiments using molecular biology technologies such as Western blot and PCR, etc.• Responsible for cell culture to maintain mammalian cell lines and experiment them with different treatments.• Conducted immunohistochemistry work with frozen tissue, paraffin section and staining techniques.• Conducted animal implants and removed induced tumors for testing.• Managed laboratory inventory supplies. Show less

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  Systems Engineering Services

  Jun 2000 - Jul 2001

  Java Developer

  Role and Responsibilities • Job involved in all the phases of software development including business requirement analysis, design, implementation and unit test.• Software design and implementation using Java2, IBM VisualAge 3.5, and Websphere 3.5 • Training: 1) Developing E-Commerce application using Java within VisualAge 2) Using J2EE in WebSphere 3.5. Show less

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  Bonfils Blood Center

  Feb 2002 - Dec 2005

  Lab Technologist II in Donor Testing Lab

  Roles and Responsibilities • Performed complex viral testing, such as Nucleic Acid Testing (NAT) with RT-PCR and Enzyme-Linked Immunosorbent Assay (ELISA) for pathogen detection, using samples from healthy donors and tissue or organ donors.• Conducted ABO/Rh blood typing and antibody screening.• Worked in a highly regulated clinical environment in compliance with stringent quality standards and safety precautions. • Provided accurate testing results and fast turn-around time. Given a title of super tech, always assigned to the heaviest and toughest spot by managers.• Managed equipment maintenance, calibration, validation, verification for Quality Control (QC) and Quality Assurance (QA) purpose.• Participated in standard operation procedures (SOPs) review and root-cause analysis for the deviations occurred, and contributed to corrective and preventive plans for continuous process improvement.• Mentored new medical technologists and performing competency tests.• Maintained excellence at custom service by answering questions from clients and solving problems for them. • Followed rules to maintain donor/patient confidentiality.• Stayed current with the competence in all testing and in the regulations from Occupational Health and Safety Administration (OSHA) and current Good Manufacturing practices (cGMP). Strictly complied with the regulations for daily operations. Show less

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  ProNeuron Biotechnologies

  Jan 2006 - Mar 2006

  Manufacturing Specialist

  Role and Responsibilities • Participated in Phase II clinical trial for spinal cord injury patients with sterile techniques in highly regulated environment.• Conducted the procedure of isolating human monocytes from blood and co-incubating them with dermis to raise macrophages using sterile techniques in biological safety cabinet in clean room.• Followed strict sterile procedures to maintain clean room free of microorganisms. Show less

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  National Jewish Health

  Jul 2006 - Oct 2014

  Lead Clinical Technologist

  Role, Responsibilities and Accomplishments• Supervised general lab daily operation at the time needed including test scheduling, critical result reviewing, testing cost analysis, inventory management, quality control and quality assurance under CLIA, ISO, OSHA, etc.• Worked as technical supervisor to train and guide staff in all the tests on the menu, • Performed bench testing, wrote SOPs and validation reports• As one of the first a few members of this lab, built this model lab with a team of 19 personnel with a strong biotech culture under the guidelines of CAP, CLIA and ISO15189.• Designed, developed, validated and commercialized of 6 molecular diagnostic tests spanning pathogen detection, genetic (predictive & prognostic tests) and pharmacogenomics using technologies such as NGS, Sanger sequencing, liquid handling robotics, qPCR, luminex bead arrays, miRNA Open Array and miRNA profiling by either working independently or collaboratively.• Monitored and trended assay performance once the tests put on bench and effectively and creatively solved many difficult technical problems and challenges. • Worked in a group to create a high growth business for National Jewish Health through Molecular diagnostics by breaking even within two years of establishment and driving aggressive revenue growth ending with $12 million revenues per year. This resulted in the Molecular Diagnostics department becoming the top 10 revenue centers within National Jewish Health.• Played a critical role at the US launch of ArcticDx’s Macula Risk test in November 2010, which was the most successful commercialization in the history of the department. Show less

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  Strand Life Sciences, Inc.

  Oct 2014 - Jul 2017

  Clinical Laboratory Senior Manager

  Role, Responsibilities and Accomplishments• First hire for this startup company. Finished the lab building and training, validated and launched 48 hot-spot oncology gene panel in less than three months. • Trained and accumulated working experience with NGS, ddPCR and pyrosequencing.• Validated the product development and launched StrandAdvantage test, a 152 gene NGS to the US market. • Wrote SOPs, validation reports and other technical documents following CLIA and CAP guidelines.• Achieved the CLIA accreditation of Strand’s US NGS clinical reference laboratory within 5 months of launch of StrandAdvantage test.• Managed this CLIA lab of 6 people, responsible for directing daily operation, staff hiring, training and mentoring, providing performance evaluations and feedback, supporting staff by assisting in laboratory testing.• Worked with lab directors and R&D team to develop scientific strategy and research directions and execute the plans.• Successfully selected high throughput FFPE DNA extraction from several options and conducted procedure improvement.• Identified key performance indicators and metrics to find assay trends, organized data and delivered reports to senior management staff.• Developed new scientific approaches by researching new methods and ideas and conducted preliminary research for macro-dissection.• Managed R&D projects, maintained inventory and produced cost effective deliverables. Show less

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  Miami Cancer Institute

  Jul 2017 - now

  Lab manager