Quality Assurance Management

SHYAMAL C. BANERJEE, PH.D.

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

636-***-**** (Cell)

Chesterfield, Missouri 63017 U. S. Citizen

636-***-**** (Home)

CAREER SUMMARY

Organic Chemist with 20+ years experience in synthesis and characterization

of active pharmaceutical ingredients (API) at Monsanto, Mallinckrodt and

Sigma Company. Analytical method development and method validation for Raw

Materials and Finished Products. Proficiencies include process safety,

process planning, equipment design, cost control, technology transfer.

Proficient in the use of online search engines (SciFinder, ISIS, Reaccs)

with a career track record characterized by solving complex research

problems and producing significant cost savings. Served as a supervisor

with strong writing and project management skills. Major accomplishments

include:

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0. Analysis and Characterization of API products .

Synthesis of Organic-Fluorinated Compounds

Methods Development of small molecules . Broad

knowledge in GLP, and cGMP.

Process Research & Process Transfer . Chromatography - HPLC,

IC, GC/MS,LC/MS

Optimization, and scale-up of API products . Multi-steps Organic

Synthesis (mg to Kilo scale)

Characterization - Complex organic molecules . Co-authored US patent

and journal publications

. Knowledge in FDA, EPA and OSHA regulations . Spectroscopy: AA, IR,

UV, NMR (1H, 13C, 19F)

APPOINTMENTS

2007- 2009 Senior Scientist, Analytical Bio-Chemistry Laboratories,

Columbia, MO

2001 - 2003 Senior Scientist, Sigma Chemical Company, St. Louis, MO

2000 - 2001 Senior Research Chemist, Mallinckrodt Inc. St. Louis, MO

1990 - 1999 Research Specialist, Monsanto Company, St. Louis, MO

1987 - 1989 Research Fellow, University of Michigan, Ann Arbor, MI

1985 - 1986 Post-Doctoral Associate, University of Minnesota,

Minneapolis, MN

1981 - 1984 Adjunct Lecturer, Queens College, Queens, New York, NY

1982 - 1984 Analytical Chemist, Chem. Tech Analytical Laboratories, New

York, N.Y.

1972 - 1980 Supervisor, Durgapur Steel Plant, Durgapur, India

PROFESSIONAL PREPARATION

The City University of New York, NY Ph. D. in Chemistry 1985

The City University of New York, NY M. Phil. In Chemistry 1983

Queens College of the City University of New York M. A. in Chemistry

1983

Indian Institute of Metals, Calcutta B.E. in Metallurgical Engineer

1980

The University of Burdwan, India M. Sc. in Synthetic Organic Chemistry

1972

The University of Burdwan, India B. Sc. (Honours in Chemistry) 1970

AFFILIATIONS

Member, American Chemical Society

PROFESSIONAL EXPERIENCES

Analytical Bio-Chemistry Laboratories, Inc. - Columbia, Missouri

2007--2009

Senior Scientist

. Multi-step synthesized and characterized 14C-radio labeled APIs and

intermediates for the Pharmaceutical and Chemical industries.

Radiochemical labeling synthesis (Carbon-14) of drug candidates under

GMP.

. Prepared batch record for c-GMP synthesis, method documentation,

specification documentation, purity profiles, control procedures and

review analytical reports.

. Organized cGMP synthesis including coordinating with facility management,

material management, quality assurance and methods development. Reviewed

data, laboratory notebooks, and reports for accuracy, completeness,

style, content, and compliance with regulations.

. Analytical method development and method validation for Raw Materials and

Finished Products.

. Responsible for analysis and characterization of complex organic

molecules and API samples by using following Spectroscopic methods: AA,

IR, UV, NMR (1H, 13C, 19F, and 2D) and X-ray Fluorescence.

. Responsible for analysis of API samples using following Chromatography

techniques: GC, HPLC, Gel/ Capillary Electrophoresis, MS, GC-MS, HPLC-MS,

and CE-MS.

Sigma Chemical Company - St. Louis, Missouri

2001 - 2003

Senior Research Scientist

. Experience in protein isolation, protein purification, protein

conjugation with biotin and characterization of protein conjugates using

LC/MS.

. Experience in organic synthesis, process development and scale-up of

chemical synthesis in the Kilo Lab.

. Analytical method development and method validation for Raw Materials and

Finished Products.

. Saved over $600,000 (catalog value) by purifying rejected material within

one week.

. Developed new method for analysis of methoxysuccinyltetrapeptide by HPLC,

NMR, GC/MS.

. Responsible for analysis of complex organic samples using following

Chromatography techniques: GC, HPLC, Gel/ Capillary Electrophoresis, MS,

GC-MS, HPLC-MS.

. Responsible for analysis and characterization of complex organic samples

by using following Spectroscopic methods: AA, IR, UV, NMR (1H, 13C, 19F,

and 2D) and X-ray Fluorescence.

Mallinckrodt Inc. - St. Louis, Missouri

2000 - 2001

Senior Research Chemist

. Developed new process for iothalamic acid using Imaging Process Research.

. Achieved cost reductions and improved quality of processes using variety

of techniques including synthesis, analysis, and purifications.

. Experience in analytical methods development for active pharmaceutical

ingredients (API), synthetic intermediates, raw materials including

development of methods for impurities and degradation products

MONSANTO COMPANY - St. Louis, Missouri 1990 - 2000

Research Specialist

. Experience in analytical methods development for active pharmaceutical

ingredients (API), synthetic intermediates, raw materials including

development of methods for impurities and degradation products

. Responsible for analysis and characterization of complex organic

molecules and API samples by using following Spectroscopic methods: AA,

IR, UV, NMR (1H, 13C, 19F, and 2D) and X-ray Fluorescence.

. Proposed two new routes to class of cholesterol lowering drugs, Ileal

Bile Acid Active Transport (IBAT) inhibitors. Developed new synthetic

routes that allowed rapid synthesis of novel analogs. One analog

currently in Phase III clinical trials. Received Reach Achievement award

for high quality work.

. Synthesized large quantities of intermediates of SOD analogs, Superoxide

Dismutase (SOD) mimics. Purified and separated large quantities of

intermediates to SOD lead compound for efficacy and safety studies.

. Worked on low cost Surfactant project for Roundup Formulations.

Synthesized over 25 surfactants, 1 of which was promising in greenhouse

test and 9 field tests in U.S. and Brazil.

. Saved money by performing root cause analysis of incident investigation

of Ileal Bile Acid Active Transport (IBAT) inhibitors projects.

. Responsible for analysis of API samples using following Chromatography

techniques: GC, HPLC, Gel/ Capillary Electrophoresis, MS, GC-MS, HPLC-MS,

and CE-MS.

. Developed Drug Delivery method for preparation of silyl linker with

misoprostol and synthesized polymer bound metronidazole as slower

released antibiotic. Received achievement award for high quality work.

. Multi-step synthesized diarylheterocycles and phenazinecarboxylic acid

analogues of COX-II inhibitor for inducible cycloxygenase (COX-II)

project.

. Synthesized series of doubly labeled tripeptides for Endothiopepsin-REDOR

project.

. Synthesized polymeric secondary amine to improve rubber quality.

. Performed technical reports using statistical and data analysis

techniques.

. Managed formulation of Roundup products.

. Responsible for management of test samples, reagents and reference

standards.

. Responsible for conducting and management of laboratory investigations,

and participating as QC representative during investigations into

deviations/exceptions and non-conformance materials.

. Presented papers and reports at the Monsanto's Technical Conference every

year.

. Reassembled HPLC instruments resulting in over $500,000 savings.

. Volunteered for United Way campaign and for Technical Community, 1999.

. Volunteered to guide and help with the St. Louis Science Fair.

. Developed sensitive assay for DNA binding and release using radio labeled

(32P) DNA.

. Developed approach for improvement of DNA delivery technology for plant

transformation by using polymer-coated metal particles.

University of Michigan - Ann Arbor, Michigan

1987 - 1989

Postdoctoral Research Fellow

. Managed one graduate and two undergraduate students for research work and

lab. Report.

. Developed unambiguous method for synthesis and analysis of ?-linked and ?-

linked glycopeptides.

. Analysis and Synthesized glycopeptides, isoglycopeptides, and fluorinated

peptide for use in studying mechanism of action of

oligosaccharyltransferase (OST).

. Responsible for analysis and characterization of complex organic

molecules and environmental samples by using following Spectroscopic

methods: AA, IR, UV, NMR (1H, 13C, 19F, and 2D) and X-ray Fluorescence.

. Responsible for analysis of complex organic molecules and environmental

samples using following Chromatography techniques: GC, HPLC, Gel/

Capillary Electrophoresis, MS, GC-MS, HPLC-MS, and CE-MS.

UNIVERSITY OF MINNESOTA - Minneapolis, MI

1985-1986

Post-doctoral Associate

. Designed and synthesized a series of sparsomycin analogs as potential

anti-tumor agents.

. Designed and synthesized a series of chloroamphenicol analogs as

potential antibiotics.

. Responsible for analysis and characterization of complex organic

molecules and environmental samples by using following Spectroscopic

methods: AA, IR, UV, NMR (1H, 13C, 19F, and 2D).

Queens College of City University of New York

1981-1984

Adjunct Lecturer

. Responsible for teaching organic and inorganic practical labs.

Prepared test papers and quizzes, evaluating results, organized and

led group discussions.

. Responsible for safety rules in the laboratory and maintaining a clean

and safe place for experiments.

Chem Tech Analytical Laboratories - New York, New York

1982 - 1984

Analytical Chemist

. Experience in analytical methods development for active pharmaceutical

ingredients (API), synthetic intermediates, raw materials including

development of methods for impurities and degradation products

. Responsible for analysis of water, soils, gas and environmental

samples using following Chromatography techniques: GC, HPLC, Gel/

Capillary Electrophoresis, MS, GC-MS, HPLC-MS, and CE-MS.

. Responsible for setting up the QC operations.

. Responsible for hiring and training of QC staff for the Laboratory.

. Responsible for the management of daily operations in the Laboratory.

. Responsible for in-process and final product testing of products.

. Responsible for management of test samples, reagents and reference

standards.

. Responsible for conducting and management of laboratory

investigations, and participating as QC representative during

investigations into deviations/exceptions and non-conformance

materials.

Durgapur Steel Plant Company - Durgapur, India

1972 - 1980

Supervisor, Analytical Chemistry Laboratory:

. Supervised QA/QC laboratory of seven chemists. Responsible for

analysis of all raw materials, steel, alloy steel, and trace organic

by-products from coke oven plants and water by wet (gravimetric,

volumetric and colorimetric analysis) and instrumental methods.

Accountable for quality of products and processes delivered on

schedule. Responsible for budgeting lab equipments, ordering chemicals

and operate, maintain the lab instruments and comply with all lab

safety rules.

. Hands on experience on the following methods to prepare, separate, and

purify the environmental samples for subsequent analysis:

Concentration, Evaporation, Solvent-solvent partitioning, Solid Phase

Extraction (SPE), Homogenization, Continuous Extraction Techniques.

. Provides training to Plant Operations personnel and Chemical

Technicians assigned to sampling responsibilities.

. Responsible for lab equipments, ordering chemicals and operating and

maintaining the lab instruments in compliance with all lab safety

rules.

PATENTS & PUBLICATIONS

Benzothiepines having activity as Inhibitors of Ileal Bile Acid Transport

and Taurocholate Uptake - Len F. Lee, Shyamal C. Banerjee, Horng-Chih

Huang, J. J. Li, R. E. Miller, D. B. Reitz, Samuel J. Tremont - US Patent

6,784,201 (August 31, 2004).

Benzothiepines having activity as Inhibitors of Ileal Bile Acid Transport

and Taurocholate Uptake - Len F. Lee, Shyamal C. Banerjee, Horng-Chih

Huang, J. J. Li, R. E. Miller, D. B. Reitz, Samuel J. Tremont - US Patent

6,387,924B2 (May 12, 2002).

Intermediates and processes for the preparation of Benzothiepines having

activity as Inhibitors of Ileal Bile Acid Transport and Taurocholate Uptake

- Len F. Lee, Shyamal C. Banerjee, Horng-Chih Huang, J. J. Li, R. E.

Miller, D. B. Reitz, Samuel J. Tremont - US Patent 6,262,277 (July 17,

2001).

Substituted 5-aryl-benzothiepines having activity as Inhibitors of Ileal

Bile Acid Transport and Taurocholate Uptake - Len F. Lee, Shyamal C.

Banerjee, Horng-Chih Huang, J. J. Li, R. E. Miller, D. B. Reitz, Samuel J.

Tremont - US Patent 6,107,494 (Aug. 22, 2000).

Novel Benzothiepines having activity as Inhibitors of Ileal Bile Acid

Transport and Taurocholate Uptake - Len F. Lee, Shyamal C. Banerjee, Horng-

Chih Huang, J. J. Li, R. E. Miller, D. B. Reitz, Samuel J. Tremont - US

Patent 5,994,391 (Nov. 30, 1999).

Discovery of Potent, Nonsystemic Apical Sodium-Codependent Bile Acid

Transporter Inhibitors (Part 1) Shyamal C. Banerjee et.al. J. Med. Chem.,

48 (18), 5837 -5852, 2005

Discovery of Potent, Nonsystemic Apical Sodium-Codependent Bile Acid

Transporter Inhibitors (Part 2) Shyamal C. Banerjee et.al. J. Med. Chem.,

48 (18), 5853 -5868, 2005.

Yeast Oligosaccharyltransferase: Glycosylation of Peptide Substrates and

Chemical Characterization of the Glycopeptide Product - R. S. Clark,

Shyamal Banerjee and J. Coward - J. Org. Chem 1990, 55, 6275-6285.

N-Glycosylation of Synthetic Peptide and Characterization of Glycopeptide

Products, R. S. Clark, Shyamal Banerjee, and J. K. Coward - Glycoconjugate

Journal 6, (1989) #436.

A Direct Synthesis of 1-Cycloalkenyl Phosphonates, Shyamal Banerjee,

Robert Engel, and George Axelrad - Phosphorus and Sulfur 15, (1985), pp.15-

18.

Synthesis of Potential Organophosphorus Metabolic Regulators, Shyamal C.

Banerjee - Diss. Abstr. Int. B 1985, 46(2), #519.

PRESENTATIONS

"N-Glycosylation of Proteins: Synthesis and Spectroscopic Characterization

of possible Peptide Substrates and Putative Glycopeptides Products" Shyamal

Banerjee, et.al. VIIIth Midwest Enzyme Chemistry Conference, Chicago, IL,

October (1988).

"N-Glycosylation of Proteins: Comparison of the Product of Enzyme-catalyzed

Glycosylation with Synthetic Glycopeptides" Shyamal Banerjee, et.al.

VIIIth Midwest Enzyme Chemistry Conference, Chicago, IL, October (1988).

"Oligosaccharyltransferase: N-Glycolylation of Synthetic Peptide and

Characterization of the Glycopeptides products" Shyamal Banerjee, R. S.

Clark and J. K. Coward, 11th Enzyme Mechanisms Conference, St. Petersburg,

FL. January (1989).

"Oligosaccharyltransferase: N-Glycolylation of Synthetic Peptide and

Characterization of the Glycopeptides products" Shyamal Banerjee, R. S.

Clark and J. K. Coward, 11th Gordon Conference on Carbohydrates, Tilton,

N.H. June (1989).

"Particle-gun Mediated Soybean and Corn Transformation" Shyamal Banerjee

et.al. Symposium on Particle Bombardment-Mediated Transformation of Plant

and Animal Systems, Middleton, WI, March (1991)

"Chemical Approach to the Improvement of Particle Gun Delivery for Plant

Transformation" Shyamal Banerjee et.al. TCM TECH Symposium, St. Louis, MO,

April (1992).

"Developed Drug Delivery method for preparation of silyl linker with

misoprostol and synthesized polymer bound metronidazole as slower released

antibiotic." Shyamal Banerjee et.al. TCM TECH Symposium, St. Louis, MO,

April (1993).

"Synthesized a series of doubly labeled tripeptides for Endothiopepsin-

REDOR project." Shyamal Banerjee et.al. TCM TECH Symposium, St. Louis, MO,

April (1994).

"Synthesized polymeric secondary amine to improve rubber quality." Shyamal

Banerjee et.al. TCM TECH Symposium, St. Louis, MO, April (1995).

"Synthesized a different variety of surfactants for Roundup Formulations."

Shyamal Banerjee et.al. TCM TECH Symposium, St. Louis, MO, April (1996).

"Synthesis and Characterization of Bile Acid Transporter Inhibitors."

Shyamal Banerjee, TCM TECH Symposium, St. Louis, MO, April (1997).

"Discovery of Potent, Nonsystemic Apical Sodium-Codependent Bile Acid

Transporter Inhibitors (Part 1)." Shyamal Banerjee et.al. TCM TECH

Symposium, St. Louis, MO, April (1998).

"Discovery of Potent, Nonsystemic Apical Sodium-Codependent Bile Acid

Transporter Inhibitors (Part 2)." Shyamal Banerjee et.al. TCM TECH

Symposium, St. Louis, MO, April (1999).

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