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Medical Device Manager

Medford, MA
October 17, 2019

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Rose Lee 832-***-**** 50 Station Landing, Medford, MA


4+ years clinical/biotechnology lab experience: HPLC, FPLC, QA/QC, CAPAs, EDMS, LIM, SOPs, ELISA, Western Blot, implementation and support of protein manufacturing processes and clinical experiment, analytical validation, technology transfer, GMP, GCP, CLIA, FDA, ISO guidance, troubleshooting

3 + years projects management experience: control documents, ANDA, PMA and 510(k) projects, IRB file Education

Rice University, Houston, TX Dec. 2018

Master of Engineering in Bioengineering

National Taiwan University (NTU), Taipei, Taiwan Jun. 2017 Bachelor of Science in Clinical Laboratory Science and Medical Biotechnology (CLSMB) Industry Experience Marigen. Boston, MA May 2019- Present

Project Specialist

- Maintain archive for compliance with product regulations and fundraising and investor information Life Science Nation. Boston, MA Jan. 2019-April 2019 Business Development Representative (Intern)

- Provided suitable recommendations and customized services by clients’ sector research from CRM CUBIO, China US Biotech Innovation Center. Houston, TX Sept. 2018-Dec. 2018 Investment Specialist - Medical Devices (Intern)

- Coordinated and maintained FDA PMA and 510(k) projects, risk management, and market analysis

- Managed vendor information such as FDA approval status, pattern and technical related information

- Supported board members and sales team by studying FDA database and medical device technology Sutton Stone, Inc. Houston, TX Sept. 2017-May 2018 Medical Business Analyst (Intern)

- Coordinated 10 projects from Abbreviated New Drug Application patents, PMA, and 510K database Far Eastern Memorial Hospital, ICU, Taipei, Taiwan Jan. 2016-Jan. 2017 Project Manager

- Managed Innovative & Noninvasive Central Venous Oximetry initiative, a medical device project

- Organized clinical investigations and assured accurate documentation required for IRB application

- Coordinated project progress, clinical related information, meeting schedules, and financial budgets National Taiwan University & National Taiwan University Hospital Jan. 2016-Jun. 2017 Medical Device Designer and Project Manager

- Led and managed the process of designing FDA Class III medical device for unmet medical needs

- Practiced FDA regulatory, approval process and ISO certifications (ISO 13485, ISO 15189, ISO9001) Department of Laboratory Medicine, NTU Hospital, Taipei, Taiwan Aug. 2015-Jan. 2016 Clinical Technician (Intern)

- Conducted clinical test protocols like cell culture and identification, HPLC, CMIA, ELISA, Western Blot

- Practiced and provided QA/QC validation support, CAPAs and, process and analytical validation procedure

- Maintained regulatory and certification documents, key study information, reports and clinical SOPs Laboratory & Science Experience

BioLegend, Inc. San Diego, CA May 2018-Aug. 2018

R&D Associate of Recombinant Protein (Intern)

- Practiced SOPs, assay optimization, technical transfers, analytical validation for protein manufacturing

- Conducted manufacturing process: cell culture(E. coli, 293E,CHO), QA/QC, HPLC, FPLC under GMP

- Provided support and uploaded in the development and execution of internal technical protocols to LIM Mei Kong Lab, Department of Cancer Biology, City of Hope, Duarte, CA Jul. 2016-Aug. 2016 Undergraduate Researcher

- Thesis: Binding site Interference between TIPRL and PP2A. Research about cell metabolic pathway Chii-Wann Lin Lab, Institute of Biomedical Engineering, NTU Jan. 2016-Jun. 2017 Undergraduate Researcher

- Used non-covalent conjugation chemistry to bind aptamers to gold nanoparticles for a low-cost IVD Honors & Skills

- Christiaan Scholtz Memorial Award. Rice University, Houston, TX 2018

- - Software skills: EDMS, LIM, CRM(Salesforce), R, Python, Excel, PowerPoint

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