Mechanical Engineering Six Sigma

PENG LI, PH.D.

* ******** **. ***. ***, Princeton, NJ 08540 C: 401-***-****

******.**@*****.***

PROFESSIONAL OVERVIEW

A dynamic, committed, and detail-oriented scientist with 3 years experience

in biotech industry. Excellent problem-solving skills combined with strong

organizational, communication and interpersonal qualities to effectively

function across multi- disciplinary departments. Highly proactive, results

and performance driven to meet and exceed business goals.

SKILLS AND EXPERTISE

cGMP: SOP writing, specifications, characterization, validation, Master

Batch Records, PM, DQ/IQ/OQ/PQ, CAPA, DMR/DHR writing.

Six Sigma: FMEA, risk analysis, verification matrix, DOE, BOM.

Biotechniques: cell culture, ELISA, fluorescence/luminescence/chromogenic

immunoassay, agglutination test, Western blot, DNA/RNA purification, PCR,

RT-PCR, real-time PCR, SNP, reverse dot blot hybridization, DNA microarray,

fluorophore and biotin protein labeling, surface functionalization,

extensive experiences in handling human saliva, blood, FFPE tissue,

cervical swab samples, cells, antibodies, disease biomarkers, enzymes,

toxins, and bacteria.

Bioanalytical/biophysical, Laboratory, and Manufacturing Skills:

. Bioanalytical/biophysical: capillary/gel electrophoresis/SDS-PAGE,

liquid chromatography, IR spectroscopy, UV spectroscopy, confocal

fluorescence microscopy, image analysis, spectrofluorometry,

protein/nucleic acid absorbance, dynamic light scattering, SEM, AFM,

profilometry, ellipsometry.

. Lab equipment: CO2 incubators, conductivity meters, osmometers,

multimeters, manometers, oxygen probes, autoclaves, centrifuges,

balances, pH meters, bio-hoods, chemical hoods, microscopes, and

cryopreservation equipment.

. Manufacturing: reagent formulation, aseptic filling, DNA microarray

fabrication, sterilization, rapid prototyping with 3D printer, soft

lithography, lamination, hot press, wet etching, sputtering, e-beam

evaporation, e-beam lithography, laser cutting, and class 100 clean

room experiences.

Design and Simulation: AutoCAD, SolidWorks, Adobe Illustrator; CFD: ANSYS,

FLUENT, and COMSOL.

Programming: extensive experiences in C++, VBA, programming liquid handler

and robotic systems, coding embedded micro-controllers.

Data Analysis: Microsoft Excel Macro, Origin, DataFit, CurveExpert,

Tecplot.

Operating System and Web: Microsoft Certificated System Engineer, HTML,

javascript, and Dreamweaver.

PROFESSIONAL EXPERIENCES

Application Scientist

09/2011-Current

Postdoctoral Researcher

03/2011-09/2011

Rheonix Inc., Ithaca, NY

. Extensive experiences in performing R&D activities and developing

manufacturing processes in accordance with cGMP regulations.

- Develop Master Batch Records for various production processes

(e.g. assay reagent production).

- Develop Specification Sheets, SOPs, and Forms for Recording Data.

- Use Six Sigma Tools (e.g. DOE, FMEA) to improve manufacturing

processes.

- Conduct characterization and validation study. Prepare validation

packages for regulatory filing.

. Develop and optimize bench top assays and conduct design

characterization and validation on biochips and robotic platforms.

- Detect KRAS mutations associated with reduced antibody drug (e.g.

Erbitux ) therapy effectiveness.

- Single nucleotide polymorphism analysis for individualized dosing

of Coumadin and Plavix .

- Molecular detection of E.Coli O157:H7 and Listeria mono. from

water and various food matrices.

- Molecular diagnosis for the agents responsible for sexually

transmitted infections (e.g. gonorrhea).

- Develop sample preparation method for human identity testing with

a short tandem repeat (STR) multiplex assay.

- All developed assays encompass DNA/RNA extraction from raw

clinical samples, nucleic acid metering, PCR or real-time PCR

amplification, and multiplexed microarray detection.

. Maintain human cell lines (e.g. C33A) and bacterial cell lines (e.g. E.

Coli). Passaging and harvesting cells. Perform cell lysis and extract

nucleic acid for analysis using qPCR or PCR and CE/gel electrophoresis.

. Manage and lead several internal R&D projects across different

departments.

- Develop the project management plan, manage the project to scope,

and identify the deliverables.

- Perform schedule risk analysis; Scope control and change

management.

- Prioritize tasks; Resolve conflicts between cross-functional

teams.

. Lead the Rheonix Hy-Fi Microarray R&D effort and transfer the process

to manufacturing.

. Lead the microfluidic biochip design and participate in sub-system

level technical reviews.

. Serve as the primary technical contact for external collaborators and

clients including Life Technologies (USA), PerkinElmer (USA), Sysmex

(Japan), Bohui Innovation (China), and Syntezza (Israel).

. Advise Research Associates and Lab Technicians on their research

projects. Review quality documents.

Executive Editor

03/2012-Current

The Journal of Bioengineering and Biomedical Sciences (JBBS), OMICS

Publishing Group, USA

. Organize editorial board meetings at respective OMICS Group conferences

or other suitable venue.

. Advise to the editorial office on the quality of manuscripts for

publication in JBBS.

. Contribute editorial/review/ research manuscript for publication in

JBBS.

. Propose new reviewers and invite colleagues to submit manuscripts.

Research Assistant

08/2006-12/2010

Department of Mechanical, Industrial and Systems Engineering, University of

Rhode Island, Kingston, RI

. Developed multiple fluorescence/luminescence immunoassays for rapid and

quantitative detection of various antibodies, biomarkers, and

pathogens, including

- An ultrafast and quantitative immunoassay for immunoglobulin G.

- Rapid C-reactive protein detection from human serum.

- Human amyloid beta immunoassay.

- Staphylococcal enterotoxin B test.

- Study antibody/antigen binding kinetics and protein adsorption.

. Developed an automated immunoassay platform consists of a miniature

spectrometer for fluorescence detection, a micropump for fluid

delivery, a disposable polymeric cartridge patterned with a

microfluidic valveless sequential loading system, a micro-controller

and a touch-screen user interface for rapid cardiac risk assessment at

the point-of-care. (In News: Medical News Today, ScienceDaily, etc.)

. Performed surface functionalization on polydimethylsiloxane microchips

with Protein A and obtained a biospecific surface that leads to the

development of the first blocking-free microfluidic immunoassay.

Visiting Researcher

Microsystems Tech. Laboratories, Massachusetts Institute of Technology,

Cambridge, MA 07/ 2007-12/2010

. Photolithography, particularly in high aspect ratio SU-8 lithography.

Microelectronics & Electron Microscopy Facilities, Brown University,

Providence, RI 03/ 2010-04/2010

. RF magnetron sputtering, E-beam evaporation, Profilometry and

ellipsometry, Focused ion beam milling/deposition, E-beam lithography.

Class 100 clean room experiences.

Institute for Microtechnology, Technical University of Braunschweig,

Braunschweig, Germany 05/2007, 06/2008

. Surface functionalization of gold and test of a quartz crystal

microbalance. Soft lithography.

EDUCATION

Ph.D. Mechanical Engineering, University of Rhode Island (GPA 4.0/4.0)

2006-2010

Field of Study: Bioanalytical device, Immunoassay development,

Microfluidics.

Coursework: Advanced analytical chemistry, General biochemistry, Methods

in biomedical physics, Advances in interfacial phenomena,

Bionanotechnology, Integrated circuit fabrication, Fluid mechanics,

etc.

M.S. Mechanical Engineering, Chinese Academy of Sciences

2003-2006

B.E. Mechanical Engineering, Zhejiang University

1999-2003

SELECTED HONORS AND AWARDS

. University of Rhode Island Graduate Fellowship (5 out of ~4500

graduate students), 2009-2010.

. National Science Foundation (NSF) EPSCoR Fellowship (only 10 honors

in RI), RI, 2008-2009.

. Excellent Undergraduate Thesis (2 out of 45), Zhejiang University,

China, 2003.

. Gold Medal of National Chemistry Olympiad, Shaanxi, China, 1998.

PATENTS

1] P. Li, L.Young, P. Zhou, Z. Chen (2013) "Magnetic beads based sample

purification", in preparation.

2] P. Li, J. Cogswell, M. Faghri (2012) "A planar labyrinth micromixer",

U.S. Patent 13/557,617.

3] P. Li, A. Sherry, M. Franzblau, D. Ouellette, M. Faghri (2010). "A

portable and automated immunosensor with an on-cartridge valveless

sequential loading system", U.S. Provisional Patent, 61/421,828.

SELECTED PUBLICATIONS

Invited book chapters:

1] P. Li (2013). "Quantitative Heterogeneous Immunoassays in Protein

Modified Polydimethylsiloxane Microfluidic Channels for Rapid Detection

of Disease Biomarkers", Microfluidic Diagnostics, Methods in Molecular

Biology Vol. 949, Humana Press, Springer Publishing Group.

Articles in preparation:

1] P. Li, G. Spizz, P. Zhou, C. McGuire, Z. Chen, R. Montagna (2013).

"Rapid and Fully Automated Molecular Testing for Pharmacogenomic

Applications", in preparation.

Articles published, or accepted to peer-reviewed journals:

1] P. Li (2012). "Microfluidics for IVD: In Pursuit of the Holy Grail",

Journal of Bioengineering and Biomedical Sciences, S8:e001, invited

editorial.

2] P. Li, A.Sherry, J. Cortex, C. Anagnostopoulos, M. Faghri (2011). "A

blocking-free microfluidic fluorescence heterogeneous immunoassay for

point-of-care diagnostics", Biomedical Microdevices Vol.13, pp. 475-483.

3] P. Li, A. Abolmaaty, C. D'Amore, S. Demming, C. Anagnostopoulos, M.

Faghri (2009). "Development of an ultrafast quantitative heterogeneous

immunoassay on pre-functionalized poly(dimethylsiloxane) microfluidic

chips for the next-generation immunosensors", Microfluidics and

Nanofluidics Vol. 7, pp. 593-598.

4] P. Li, J. Cogswell, M. Faghri (2012). "Design and test of a passive

planar labyrinth micromixer for rapid fluid mixing", Sensors and

Actuators B: Chemical Vol.174, pp.126-132.

5] P. Li, M. Gong, J. Wu (2008). "Geometric optimization of an active

magnetic regenerative refrigerator via second-law analysis", Journal of

Applied Physics Vol.104, pp. 103536.

6] P. Li, M. Gong, G. Yao, J. Wu (2006). "A Practical model for analysis of

active magnetic regenerative refrigerators for room temperature

applications", Int. Journal of Refrigeration Vol. 29, pp. 1259-1266.

Contributed peer-reviewed conference publications:

1] P. Li, H. Chen, C. Anagnostopoulos, M. Faghri (2010). "Fluorescence

amplification using biospecific nanoparticle conjugates as labels in

microfluidic heterogeneous immunoassays", Proc. of the ASME 2010 NEMB,

(Houston, TX), NEMB2010-13234.

2] M. Faghri, P. Li (2009). "Development of a microfluidic fluorescence

immunosensor for point-of-care diagnostics", Proceedings of the 2nd

WSEAS International Conference on Biomedical Electronics and Biomedical

Informatics (Moscow, Russia), pp. 253-258, invited paper.

3] P. Li, R. Narayanan, A. Sherry, J. Cortex, A. Marchesseault, C.

Anagnostopoulos, M. Faghri (2009). "A blocking-free microfluidic

fluorescence heterogeneous immunoassay for quantitative detection of

human C-reactive protein", Proc. of the 2009 ASME IMECE (Lake Buena

Vista, FL), IMECE2009-10904.

4] H. Chen, A. Abolmaaty, P. Li, C. Anagnostopoulos, S. D bel, M. Faghri

(2009). "Heterogeneous detection of PCR-amplified intimin gene from E.

Coli O157:H7 via PDMS microfluidic chip", Proc. of the ASME IMECE (Lake

Buena Vista, FL), IMECE2009-11796.

5] P. Li, A. Abolmaaty, T. Barek, C. Anagnostopoulos, M. Faghri (2008).

"Time optimization of heterogeneous immunoassay using PDMS microfluidic

chip for quantitative detection of a model analyte", Proceedings of the

6th ASME ICNMM, (Darmstadt, Germany), ICNMM2008-62294, pp. 1511-1515.

SELECTED PRESENTATIONS AND POSTERS

1] P. Li, "The challenges of developing and commercializing microfluidic

devices for in vitro diagnostics applications", The 2nd International

Conference and Exhibition on Biosensors & Bioelectronics, Chicago, USA,

June, 2013, plenary speaker.

2] P. Li, A.Sherry, M.Franzblau, D.Ouellette, M.Muller, J.Cortes,

M.Plouffe, C.Anagnostopoulos, M.Faghri, "A portable and automated

microfluidic fluorescence immunosensor for rapid cardiac risk assessment

at POC", Bioanalytical Sensors, Gordon Research Conference, Colby-Sawyer

College, NH, June, 2010, poster 30.

3] P. Li, "A planar labyrinth micromixer", The 41st New England Complex

Fluids Workgroup, Harvard University, Boston, MA, December, 2009.

4] P. Li, "A blocking-free microfluidic fluorescence heterogeneous

immunoassay for point-of-care diagnostics", The 2009 ASME IMECE, Lake

Buena Vista, FL, November, 2009.

5] P. Li, A. Sherry, M. Muller, C. Anagnostopoulos, M. Faghri, "A portable

microfluidic optical sensor for simultaneous multianalyte detection",

Lab-on-a-chip World Congress, South San Francisco, CA, August, 2009,

poster 1025.

6] P. Li, "Development of a microfluidic immunosensor with micro-fabricated

fluorescence amplifier for rapid detection of pathogens", Institute for

Microtechnology, Technical University of Braunschweig, Braunschweig,

Germany, June, 2008, invited speaker.

7] P. Li, "Time optimization of heterogeneous immunoassay using PDMS

microfluidic chip for quantitative detection of a model analyte", The

6th ASME ICNMM, Darmstadt, Germany, June, 2008.

8] P. Li, "Microfluidic devices for detection of biomarkers of infection",

Technical Institute of Physics and Chemistry, Chinese Academy of

Sciences, Beijing, China, May, 2008, invited speaker.

ACADEMIC SERVICES

. Editorial Services:

Executive Editor for the Journal of Bioengineering & Biomedical

Sciences, since March 2012.

Editorial Board Member for the Biosensors Journal, since October 2013.

Editorial Board Member for the Int. J. of Material and Mechanical

Engineering, April 2012-March, 2013.

Special Issue Editor on Microfluidics for the Journal of Bioengineering

& Biomedical Sciences, 2011

. Invited Journal and Conference Reviewer:

Analytical Chemistry, 2013

Applied Physics Letter, 2007, 2008, 2009, 2011, 2012

Bioanalysis, 2011.

ChemComm, 2013.

Chemical Engineering & Technology, 2013.

International Heat Transfer Conference (IHTC-14), Washington D.C., USA,

2010

International Journal of Material and Mechanical Engineering, 2012

Journal of Micromech. Microeng., 2011, 2012.

Journal of Physics D: Applied Physics, 2013.

Lab on a Chip, 2011, 2012, 2013.

Measurement Science Technology, 2012.

Nanotechnology, 2011, 2012.

. Invited Organizing Committee:

The 3rd International Conference & Exhibition on Biosensors &

Bioelectronics, San Antonio, USA, 2014.

International Conference & Exhibition on Biochemical & Molecular

Engineering, San Antonio, USA, 2013.

The 2nd International Conference & Exhibition on Biosensors &

Bioelectronics, Chicago, USA, June, 2013.

The 2nd International Conference & Exhibition on Biometrics &

Biostatistics, Chicago, USA, June, 2013.

Biofest 2012, International Bio Conference and Exhibition, Hyderabad,

India, December, 2012.

OTHER INFORMAITON

Immigration Status: Permanent Resident (received Green CARD under

outstanding professors/researchers).

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