Summary
Overview
Work History
Education
Skills
Publications
References
Timeline
Generic

Peng Li

Newtown,PA

Summary

Analyst, QC Chemistry position in pharmaceutical industry.

Overview

20
20
years of professional experience

Work History

AR&D Group Leader/Asst manager

KVK Tech Inc
Newtown, PA
01.2018 - Current
  • Lead raw material team in AR&D department and responsible for analytical method develop and validation/verification of raw materials and active pharmaceutical ingredients (APIs)
  • Perform QC chemistry laboratory testing for finish products, intermediate product and raw material
  • Provides bench level leadership in regards to develop, validate, and transfers robust analytical methods for testing of raw materials, APIs, in process and finished drug products
  • Leading role in development procedure for evaluation of company’s first abuse deterrent formulation (ADF) Opioid drug product per FDA Guidance
  • Prepare and review technical documents: analytical method validation/verification protocol and report, standard operation procedure (SOP), ANDA regulatory submissions and response to FDA deficiency letter
  • Conduct LIR/OOS/ investigations for root cause evaluation for failure results through the scientific judgement
  • Project management and assignment, laboratory management
  • Preparation, Review and Execution of Qualification procedures (IQ, OQ & PQ) for the new instrument.

QC/AR&D Scientist / Senior AR&D Scientist

KVK Tech Inc
Newtown, PA
08.2012 - 01.2018
  • Lead raw material team in AR&D department and responsible for analytical method develop and validation/verification of raw materials and active pharmaceutical ingredients (APIs)
  • Perform QC chemistry laboratory testing for finish products, intermediate product and raw material
  • Provides bench level leadership in regards to develop, validate, and transfers robust analytical methods for testing of raw materials, APIs, in process and finished drug products
  • Leading role in development procedure for evaluation of company’s first abuse deterrent formulation (ADF) Opioid drug product per FDA Guidance
  • Prepare and review technical documents: analytical method validation/verification protocol and report, standard operation procedure (SOP), ANDA regulatory submissions and response to FDA deficiency letter
  • Conduct LIR/OOS/ investigations for root cause evaluation for failure results through the scientific judgement
  • Project management and assignment, laboratory management
  • Preparation, Review and Execution of Qualification procedures (IQ, OQ & PQ) for the new instrument.

Chemist

Princeton Global Synthesis LLC
Bristol, PA
01.2010 - 07.2012
  • Responsible for purification and quality control of raw materials, intermediate products and final products
  • Laboratory management and maintenance of analytical instrument (HPLC, GC, UV-Vis).

Chemist

A&C Pharmtech INC
Bristol, PA
01.2009 - 01.2010
  • Responsible for analysis of intermediate and final products and maintenance of analytical instruments.

Postdoctoral Researcher Associate

Center for Biological Investigations, Spanish Research Council
Madrid, Spain
04.2008 - 10.2008
  • Conducted research on kinetics of protein folding by utilizing infrared, fluorescence, laser spectroscopy, and HPLC, MS, and CD spectroscopy
  • Designed and set up a laser spectroscopy lab to study kinetics and mechanism of protein folding
  • Research projects under European Union’s Sixth Framework Program have been carried out in this lab.

Postdoctoral Researcher Associate

Chem & Biochem Dept, University of Maryland at College Park
Maryland
09.2004 - 04.2008
  • Conducted research on kinetics of protein folding by utilizing infrared, fluorescence, laser spectroscopy, and HPLC, MS, and CD spectroscopy
  • Designed and set up a laser spectroscopy lab to study kinetics and mechanism of protein folding
  • Research projects under European Union’s Sixth Framework Program have been carried out in this lab.

Education

Ph.D. in Chemistry -

Chemistry Department, National University of Singapore
01.2004

MS. in Chemistry -

Chemistry Department, Lanzhou University
01.1999

BS. in Chemistry -

Chemistry Department, Lanzhou University
01.1996

Skills

  • Experienced QC/Analytical R&DC Scientist with Pharmaceutical experience in all stage of generic pharmaceutical product development Specialize in development and validation of analytical methods (Impurities, Assay, Residual Solvent, Particle size distribution, et al) for drug products and drug substances in pharmaceutical industry In depth understanding of the principles of modern chromatography and spectroscopic techniques commonly used for analytical chemistry, such as UPLC, HPLC, GC, FT-IR, UV/Vis Spectroscopy Good knowledge in TLC, Karl Fischer titrator, Potentiometric Titration, Viscometer, and Malvern Mastersizer particle size analyzer GMP experience in pharmaceutical industry, good understanding of USP compendia documents, ICH guidelines and FDA guidance Hands on experience with various scientific software including Waters Empower, Agilent Chemstation, Master Control Critical thinking, strong problem solving ability, multidisciplinary-working experience

Publications

  • Peng Li, Fabiana Y. Oliva, Athi N. Narayanan, Victor Muñoz, Dynamics of One-State Downhill Protein Folding, Proceedings of the National Academy of Sciences, 106, 103 (2009).
  • Athi N. Naganathan, Peng Li, Raúl Pérez-Jiménez, Jose M. Sanchez-Ruiz, Victor Muñoz, Navigating the downhill protein folding regime via structural homologues, Journal of the American Chemical Society, 132, 11183 (2010).
  • Adam Fung, Peng Li, R. Godoy-Ruiz, J. M. Sanchez-Ruiz, Victor Muñoz, Expanding the Realm of Ultrafast Protein Folding: gpW, A Mid-Size Natural Single-Domain with Novel Topology that Folds Downhill, Journal of the American Chemical Society，130, 7489 (2008).
  • Thiam Seong Chong; Peng Li; Weng Kee Leong; Wai Yip Fan, “TR-FTIR absorption spectroscopy of transition metal carbonyl radicals generated by photodissociation of metal–metal bonds, by halogen abstraction or by radical ligand substitution”, Journal of Organometallic Chemistry, 690, 4132 (2005).
  • Peng Li, Wai Yip Fan, “Energy distributions of CO produced in an acetone-containing discharge”, Chemical Physics Letters, 390, 323 (2004).
  • Peng Li, Yen Ling Tan, and Wai Yip Fan, “The CN and CS Transient Species in CH3SCN Discharge”, Chemical Physics, 302, 171 (2004).
  • Peng Li, Ling Keong Wong, Wai Yip Fan, “Vibrational Spectroscopy and 266 nm Photochemistry of NCNCS and CNCN”, Chemical Physics Letters, 380, 117 (2003).
  • Peng Li, Wai Yip Fan, “The CN Free Radical in Acetonitrile Discharge”, J. of Applied Physics, 93, 9497 (2003).
  • Peng Li, Wai Yip Fan, “Characterization of SiN and other transient species in a silicon tetrachloride-nitrogen discharge”, Chemical Physics Letters, 367, 645, (2003).
  • Li P, An XQ, Shen WG, “Density, turbidity and microscopic structure of AOT/H2O/Oil microemulsions”, Acta Physico-Chimica Sinica, 17, 144, (2001).
  • An Xueqin, Li Peng, Zhao Haihong, Shen Weiguo, “The coexistence curves of {xC6H5NO2 + (1-x)CH3(CH2)3CH3} and {xC6H5NO2 + (1-x)CH3(CH2)8CH3} in the critical region”, Journal of Chemical Thermodynamics, 30, 1049, (1998).

References

Available upon request.

Timeline

AR&D Group Leader/Asst manager

KVK Tech Inc
01.2018 - Current

QC/AR&D Scientist / Senior AR&D Scientist

KVK Tech Inc
08.2012 - 01.2018

Chemist

Princeton Global Synthesis LLC
01.2010 - 07.2012

Chemist

A&C Pharmtech INC
01.2009 - 01.2010

Postdoctoral Researcher Associate

Center for Biological Investigations, Spanish Research Council
04.2008 - 10.2008

Postdoctoral Researcher Associate

Chem & Biochem Dept, University of Maryland at College Park
09.2004 - 04.2008

Ph.D. in Chemistry -

Chemistry Department, National University of Singapore

MS. in Chemistry -

Chemistry Department, Lanzhou University

BS. in Chemistry -

Chemistry Department, Lanzhou University

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