Jake (Jinsu) Kim

Personal Information

Address: **** ****** **, ********, ** 08873

Cell phone: (732) 585 - 0444

E-mail: adcm8y@r.postjobfree.com

Visa Status: South Korea citizen with US permanent resident (green card holder).

Objective

Seeking a validation engineer position for the Quality Management System in the drug and medical device industries.

Provide scientific input into the quality control strategy for the product safety, efficacy and consistency.

Support the technical content writing and critical review.

Identify, communicate and escalate potential risks.

Develop validation methods and standards for products and processes in compliance with global regulation and guidelines.

Selected Achievement

Completed design control training for medical devices and certified by Oriel STAT A MATRIX.

Established and conducted verification and validation protocols for Class III in-vitro diagnostic medical devices and production processes.

oDesign verification and validation: specimen type equivalency and stability, precision of measurement, validation of reading time, diagnostic sensitivity and specificity, shelf-life, flex studies and clinical performance

oProcess verification and validation: gold conjugation, biotinylation, membrane printing and blocking, device assembly, cleaning, pouching, kit boxing and labeling processes

Generated design control documents in each design phase: design plan, design input, design output, design review, design change, verification and validation, design history file and design master record.

Conducted equipment qualification at the phase of technology transfer: cutting machine, freeze dryer, bottling machine, pouching machine and dressing machines.

Submitted design dossier of an in-vitro diagnostic medical device (IVDD) to TUV SUD for the CE mark application.

Professional Experience

Access Bio, Inc., Somerset, NJ, USA 03/2018 – Present

Associate Principal Scientist, R&D

Leading a design and engineering team to commercialize all-in-one lateral flow assay for testing HIV-1/2 antibody in human blood for both professional and self-testing use.

Leading a design and engineering teams to develop in-vitro lateral flow assay for testing Hepatitis C Virus antibody in human blood.

Operating clinical and usability studies for HIV self-testing in Kenya, South Africa, Ethiopia, Zimbabwe, Malawi and Europe.

Generating and maintaining design control documents in each design phase.

Performing equipment qualification (IQ/OQ/PQ) and production process validation.

Conducting FMEA for risk management and risk mitigation activities according to ISO 14971 throughout the design and development process.

Preparing regulatory submission for WHO PQ and CE mark for Class III in-vitro diagnostic devices.

Working knowledge of quality system regulation of 21 CFR Part 820 and ISO 13485:2016 for medical devices.

Mentoring research associates and technicians with research design, comprehensive training, and progress review.

Cornell University, Ithaca, NY, USA 10/2016 – 03/2018

Postdoctoral Researcher in the Division of Nutritional Sciences

Research Topics:

6-plex lateral flow assay for acute febrile illness using a mobile device.

Personalization of nutritional status in the context of vitamin D status and immune function.

On-site interferon-gamma release assay for latent tuberculosis infection in resource-limited settings.

Developed 2-plex lateral flow assay for Plasmodium falciparum and vivax malaria.

Supervised 2 undergraduate researchers with research design, comprehensive training, and progress review.

Education

Ph.D. in Chemical and Biomolecular Engineering 08/2011 – 10/2016

University of Houston, Houston, TX, USA

Dissertation: Bacteriophage Imaging Lateral Flow Assay for Point of Care Diagnostics.

Developed and characterized ultra-sensitive lateral flow assay using viral nanoparticles.

Discovered a theory of better binding efficiency in rod-like nanoparticles than in spherical nanoparticle for lateral flow immunoassay.

Led development of chemiluminescence assay for diagnosis of type 2 diabetes.

Experienced in M13 bacteriophage genome analysis using Illumina next-generation DNA sequencing.

Assisted in lab management, including coordination, documentation, and instrument maintenance.

Published original research in high-impact journals and delivered compelling presentations in highly influential conferences.

M.S. in Chemical Engineering 03/2009 – 02/2011

Kyungpook National University, Daegu, South Korea

Thesis: Dynamics Study for Temperature Oscillation in Methanol Partial Oxidation.

B.S. in Chemical Engineering 03/2002 – 02/2009

Kyungpook National University, Daegu, South Korea

Completed Accreditation Board for Engineering Education of Korea (ABEEK).

Biology Laboratory Skills

Microscopy: Brightfield, Darkfield, Epi-fluorescence, Confocal microscopy.

Immunoassay: ELISA, Magnetic particle immunoassay, Lateral flow immunoassay, Fluorescence immunoassay, Chemiluminescence assay.

Bio-conjugation: EDC/NHS coupling, Maleimide-thiol coupling, Silane coupling, Avidin-Biotin conjugation.

Molecular biology: FPLC, SDS-PAGE, Octet, SEC-MALS, Illumina next-generation DNA sequencing, Plasmid purification, Agarose gel electrophoresis, Gel DNA recovery, PCR, RT-PCR, Bacteriophage growth and purification, Virus titeration.

Computer Skills

Programing: Matlab, LabView, Java.

Presentation: Origin, Adobe Illustrator, Microsoft Suite.

Drawing: AutoCAD.

Publications

[1] Kim, J.; Kao, X. E.; Finkelstein, J. L.; Cárdenas, W. B.; Erickson, D; Mehta, S., A Two-Color

Multiplexed Lateral Flow Immunoassay System to Differentially Detect Human Malaria Species on A Single

Test Line. Malaria Journal, 2019, 18:313.

[2] Kim, J.; Vu B.; Kourentzi, K.; Willson R. C.; Conrad, J. C., Increasing Binding Efficiency via Reporter

Shape and Flux in a Viral Nanoparticle Lateral-Flow Assay. ACS Appl. Mater. Interfaces, 2017, 9(8),

6878−6884.

[3] Kim, J.; Poling-Skutvik, R.; Trabuco, J. R. C.; Kourentzi, K.; Willson R. C.; Conrad, J. C., Orientational

Binding Modes of Reporters in A Viral-nanoparticle Lateral Flow Assay. Analyst, 2017, 142, 55-64.

(Designated a HOT article and featured on the cover of Issue 1, 2017)

[4] Chen, H.; Hagstrom, A. E. V.; Kim, J.; Garvey, G.; Paterson, A.; Ruiz-Ruiz F.; Raja, B.; Strych U.; Rito-Palomares, M.; Kourentzi, K.; Conrad, J. C.; Atmar, R. L.; Willson R. C., Flotation Immunoassay Masking the Signal from Free Reporters in Sandwich Immunoassays. Scientific Reports, 2016, 6, 24297.

[5] Adhikari, M.; Strych, U.; Kim, J.; Goux, H.; Dhamane, S.; Poongavanam, M.; Hagström, A. E. V.; Kourentzi, K.; Conrad, J. C.; Willson, R. C., Aptamer-phage Reporters for Ultrasensitive Lateral Flow Assays. ACS Anal. Chem., 2015, 87(23), 11660–11665.

[6] Kim, J.; Adhikari, M.; Dhamane, S.; Hagström, A. E. V.; Kourentzi, K.; Strych U.; Willson, R. C.; Conrad, J. C., Detection of Viruses by Counting Single Fluorescent Genetically Biotinylated Reporter Immunophage Using a Lateral Flow Assay. ACS Appl. Mater. Interfaces, 2015, 7, 2891−2898.

[7] Kim, J.; Byeon, J.; Seo, I. G.; Lee, H. C.; Kim, D. H.; Lee, J., Temperature oscillations in methanol partial oxidation reactor for the production of hydrogen. KJChE, 2013, 30(4), 790-795.

[8] Kim, J.; Byeon, J.; Sung, S. W.; Lee, J.; Edgar, T. F., Multiple Switching Relays for the Estimation of Ultimate Data. IJCAS, 2011, 9(2), 294-300.

[9] Byeon, J.; Kim, J.; Sung, S. W.; Ryoo, W.; Lee, J., Third Quadrant Nyquist Point for the Relay Feedback Autotuning of PI Controllers. KJChE, 2011, 28(2), 342-347.

[10] Lee, J.; Kim, J.; Byeon, J.; Sung, S. W.; Edgar, T. F., Relay Feedback Identification for Processes under

Drift and Noisy Environments. AIChE J., 2010, 57(7), 1809-1816.

[11] Jeon, C. H.; Cheon, Y. J.; Kim, J.; Lee, J.; Sung, S. W., Relay Feedback Methods Combining Sub-Relays to Reduce Harmonics. J. Process Control, 2010, 20, 228-234.

[12] Kim, J.; Byeon, J.; Chun, D.; Sung, S. W.; Lee, J.; Edgar, T. F., Relay Feedback Method for Processes under Noisy Environments. AIChE J., 2009, 56, 560-562.

Patents

[1] Willson R. C.; Kim, J.; Vu B.; Villegas, O. P. V; Ruiz F. A. R.; Palomares, M. A. R., Systems and Methods

for Direction of Chemiluminescent Reaction. U.S Patent, US20180031484A1, filed July 27, 2017,

and issued February 1, 2018.

[2] Lee, J.; Byeon, J.; Kim, J.; Sung, S. W.; Cheon, D., Apparatus for Liquid Level Controlling Experiment.

South Korea Patent, KR101011574B1, filed February 9, 2009, and issued January 27, 2011.

References

[1] General Manager, Dr. Jun Yong Ha

Supervisor (03/2018 – Present)

Division of R&D, Access Bio, Inc., Somerset, NJ, USA

Telephone: 732-***-**** / E-mail: adcm8y@r.postjobfree.com

[2] Associate Professor Dr. Saurabh Mehta

Postdoc Mentor (10/2016 – 03/2018)

Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA

Telephone: 607-***-**** / E-mail: adcm8y@r.postjobfree.com

[3] Associate Professor Dr. Jacinta C. Conrad

Ph.D. Dissertation Advisor (01/2012 – 08/2016)

Department of Chemical Engineering, University of Houston, Houston, TX, USA

Telephone: 713-***-**** / E-mail: adcm8y@r.postjobfree.com

[4] Professor Dr. Richard C. Willson

Ph.D. Dissertation Co-advisor (01/2012–08/2016)

Department of Chemical Engineering, University of Houston, Houston, TX, USA

Telephone:713-***-**** / E-mail: adcm8y@r.postjobfree.com

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