Customer Service Quality Control

Jingzhi Pan, Ph.D.

* *** ***** *****, ********, IL 60126 (814) 321- 6744

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

SUMMARY OF QUALIFICATIONS

. State-of-the art knowledge on column (liquid) chromatography with

extensive hand-on experience in analytical and preparative HPLC

. Competent in analytical chemistry with ability of serving as invited

reviewer for The International Journal of Pure and Applied Analytical

Chemistry

. Expertise in protein biochemistry with extensive hand-on experience in

protein and peptide characterization and purification

. Nearly nine years industrial experience emphasizing quality control,

laboratory operation, project management, method transfer, product

development, and document writing

. Substantial knowledge of cGMP, FDA, ICH and Compendia requirement

especially in analytical method development, validation and CMC section

for regulatory submission

. A self-motivated, results-oriented, and hard-working scientist capable of

effective communication and fast learning; an leader able to manage

multiple projects and problem solve technically challenging issues

TECHNICAL PROFICIENCIES

. Chromatography: analysis & separation, applications, products,

instrumentations, and laboratory setting

. Pharmaceutical analysis: HPLC, UPLC, mass spec platforms (LC-MS,

LC/MS/MS), TLC, GC, KF titration, UV/VIS, Inductivity Coupled Plasma (ICP-

OES), sample preparation for bioanalysis, solid phase extraction (SPE)

and Wet chemistry

. Biotechnology and biopharmaceutical analysis: MALDI-TOF, affinity

chromatography, FPLC, electrophoresis (SDS-PAGE, IF, 2-D), peptide

mapping, amino acid analysis and sequencing, database searching, western

blot, radioimmunoassay (RIA), ELISA, carbohydrate analysis, cell-based

bioassay, immunohistochemistry, filtration, precipitation, and

ultrafiltration

. Other job related skills: HP chemstation, Waters Empower, Trackwise,

Microsoft Word, Excel, Outlook, PowerPoint and basic statistical analyses

SELECTED ACCOMPLISHMENTS

. Led project in developing and manufacturing of a new HPLC stationary

phase from concept to commercialization; gained a few hundred thousand-

dollar sale

. Received an "Excellence In Customer Service" award by providing a

pharmaceutical company with a special HPLC column through innovative

procedures; secured about $100,000 annual sale

. Accomplished in training of sale managers nationwide for Sigma-Aldrich

China with HPLC theories, instruments and products

. Initiated new concept into development of HPLC impurities methods, which

cut labor consuming of the methods by about 90%

. Managed a project across multiple departments with QC, QA and Regulatory

Affairs, which ensured urgent release of API for a regulated product

. Published and presented 25 research articles in peer-review journals and

in scientific conferences

. Successfully identified, characterized and purified a numbers of novel

bioactive peptides and proteins with various functions

. Received "Go Extra Mile" Award in 3 consecutive years and promoted from

Research Associate to Research Scientist within 2 years

PROFESSIONAL EXPERIENCE

Celgene, Abraxis Bioscience Division- Melrose Park, IL

2008 - Present

Principal Scientist/Supervisor, Product Development for Protein-Based

Parenteral Drugs

. Manage daily laboratory operations, scheduling tests, resolving problems

and prioritizing projects in a fast paced environment; participate in

hiring, performance review, and development of personnel

. Supervise senior scientists/scientists for projects in method

development/validation and stability related testing involved in pre-

clinical, clinical, and commercial products leading for CMC submission

. Develop and validate analytical methods (assay, impurities, Chiral) for

raw material, API, in-process sample and finished product (Injectable

suspension) by employing various analytical techniques and

instrumentation

. Oversee instrument and supply; identify capital equipment needed;

implement safety and chemical hygiene practices

. Conduct in-depth studies for troubleshooting, OOS/OOT and deviation

investigations; prepare root cause analysis and CAPA proposal

. Write, review and approve SOP, study protocol, report, Certificate of

Analysis, and product specification

. Comment on and approve CMC section for submissions; collaborate with QC,

QA and Regulatory Affair Departments including transfer methods over to

QC under cGMP conditions

. Provide leadership and subject matter expertise to ensure analytical

methods in compliance with cGMP, FDA, ICH and current compendia (USP, EP,

BP & JP)

. Organize and provide technical seminars for analysts emphasizing new

technologies

Sigma-Aldrich, Supelco Division - Bellefonte, PA

2002 - 2008

Senior R & D Scientist, R & D Department

. Lead scientist responsible for projects in development of HPLC products

from concept to commercialization using organic and surface chemistry

. Managed projects on process improvement across internal functional and

organizational lines with scientist, QC chemist, and manufacturing

personnel

. Developed analytical methods (HPLC, LC-MS, SPE, Diagnostics) for small

molecules, pharmaceutical substances, proteins, peptides, antibodies, and

environmental analysis

. Provided expertise and technical support including method troubleshooting

to external customers e.g. pharmaceutical and biopharmaceutical companies

. Transferred technologies from R&D to manufacture; provided

troubleshooting and training for manufacturing department; initiated

studies to identify root cause for product defeats

. Served as integral part of a team responsible for the technical transfer

of chiral column technology into ISO9000 setting

. Prepared comprehensive reports on project analysis and results; wrote and

reviewed protocols, technical documentations, and standard operating

procedures

. Developed various QC methods for Quality Control department and trained

QC chemists

University of Texas Medical Branch - Galveston, TX

1997 - 2002

Research Scientist, Department of Microbiology and Immunology

. Purified novel proteins with anti-virus potential by optimization of

purification process using conventional column chromatography (RP, IEX,

HIC, affinity, etc), filtration and lyophilization

. Developed analytical methods to characterize proteins and antibodies with

immuno-precipitation, electrophoresis, MALDI-TOF, Western blot, virus

assay, and antibody assay

. Conducted in-depth studies on antibodies in patient's serum with HIV

chronic infection and the roles of neutralizing antibody for early

detection of HIV infection

. Resolved technically challenging problems by working both independently

and with multidisciplinary research team involved in biochemistry,

immunology, and virology

. Initiated experimental design; wrote comprehensive reports on data

analysis; presented scientific findings in conferences; published

articles in peer-reviewed journals

. Trained postgraduate students and lab technicians

Previous Experience

University of Manitoba, Canada; Ohio State University, USA; The Queen's

University of Belfast, United Kingdom; Sun Yet-sen University of Medical

Sciences, China

. Directed research projects to understand mechanism of drug resistance of

pathogens through leadership, planning and problem solving

. Managed a core laboratory and budget including supervision and mentoring

of technicians and students

. Researched on purification and characterization of novel bioactive

peptides using column chromatography, amino acid sequencing,

radioimmunoassay, immunochemical detection, florescence microscopy, and

confocal laser scanning microscopy

. Studied molecular interaction and folding profile of bioactive peptide by

computer simulation technology

. Built and managed HPLC in a field station; researched novel biochemical

methodologies for dietary protein and metabolism studies

. Characterized proteins using electrophoresis, MALDI-TOF, peptide map,

amino acid analysis, amino-acid sequencing, and in-gel digestion

. Purified novel proteins from insect venom with anti-angiogenesis property

using RP, IEX, and SEC chromatography

. Developed enzyme-linked immunosorbent assay (ELISA) for characterization

of proteases responsible for IGF from human plasma

. Supervised a bench scale protein purification facility including

technical support and troubleshooting of protein purification processes

for users

EDUCATION

. Doctor of Philosophy, Biochemistry, The Queen's University of Belfast,

United Kingdom

(Recipient of the three International Ph.D. Full Scholarships offered

annually by the university)

. Master of Science, Medical Biochemistry, Sun Yat-sen University of

Medical Sciences, China

. Bachelor of Science, Biological Science, Zhongshan University, China

PROFESSIONAL AFFILIATIONS (Past and Present)

American Association of Pharmaceutical Scientists; American Chemical

Society; American Society for Biochemistry and Molecular Biology; American

Society for Virology

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