Six Sigma Development

GOPAL K. PAUL

**** ****** **** *****, **. Louis, MO 63132

Tel & Fax: 314-***-**** (Mobile)

E-mail: *******@*****.***

Citizenship: USA

Objective

To secure a challenging and responsible position QC/R&D arena where my 12 years

expertise as senior analytical chemist will be utilized

Qualification Summary

• Experience, proficiency in analytical methodologies and problem solving skills –

UPLC, HPLC, GC, NMR, LC-MS, Dissolution, titration, etc.

• Initiate, analyze/release and maintain stability database (Accelerated and long term) in StarLIMS

• Initiate, write, and review LIR/OOS/OOT, deviation, and change control investigations and

reports in StarLIMS.

• Ability to independently lead analytically intensive projects both internally and

externally with partners

• Designing experiments and conducting analyses, or supervising technicians

conducting analyses that enable the characterization and quantification of APIs, Drug

products, dissolution, etc.

• Leading the identification and determination of impurity profile of APIs and

formulated drug products. Lead and mentor other technicians and small teams.

• Collaborating with external partners for method development, validation and

technical transfers.

• Ability to identify, communicate and implement ideas related to future analytical

capabilities and their application beyond current individual project scope and responsibilities.

• Expanding analytical capabilities to advance R&D; leadership position and customer

technical service.

• Providing analytical leadership, C-GMP compliances and support for the regulatory

agencies.

• Documenting/maintaining technical details, written reports and oral presentations .

Background

• More than 10 years of experience in pharmaceutical/chemical/nutraceutical industries

• Development, establishment and validation of analytical testing methods (HPLC, UPLC,

GC, HS-GC, GC-MS, NMR, LC-MS) of raw materials, intermediates and finish products.

• Identify and document critical in-process-control issues and critical factors that affect

method performance and develop appropriate analytical methods (Six Sigma, QbD).

• Design, monitor and execute release and stability study of drug substances, drug products

and excipients (LIMS). Set and justify specification as per ICH/USP/EP guidelines.

• Review OOS, OOT and method performance issues and conduct investigations. Document

and implement corrective/preventive actions (CAPA) as needed.

• Participate in analytical activities for submitting ANDA/NDA to FDA through QbD

framework.

• Present to cross functional teams and to communicate critical analytical issues and

solutions.

• Review, write and approve technical reports to document analytical method/protocol/SOP.

• Work closely with CROs/CMOs to accomplish outsourced tasks, conduct meetings to

resolve issues and propose acceptable solution to all parties.

• Assist with formulation development, excipients interaction with APIs and optimization.

• Perform/guide work on IQ/OQ/PQ of analytical equipment.

• Broad understanding of ICH, FDA and USP/EP guidelines, including the ability to apply

the guidelines in context of the stages of pharmaceutical development and submission.

• Ability to work successfully in both a team/matrix environment in a fast pace environment,

manage priorities, and maintain timelines for multiple activities.

Technical Skills

• HPLC, UPLC, SEC, SPE, NMR, LC-MS, GC, GC-MS, UV/VIS, FT-IR, Dissolution, KF,

AA and Titration

• NMR Structural elucidation of unknown APIs/impurities, degradation products,

extractable/leachable

• c-GMP: ICH/USP/EP guidelines; Data review and documentation; OOS/OOT/CAPA

• Stability Study program, Degradation Study and Setting Specifications (DS/DP/Impurity)

• Instrument calibration, maintenance and troubleshooting

• Software: Empower/ChemStation/Turbochrome, Xcalibur, Chemdraw, Visio, LIMS,

Minitab, JMP, etc.

Professional Experience

Senior Analytical Process Control Analyst

1. Teva Pharmaceuticals, Inc., August 2013-Present

• APIs Method Development, Validation, Stability Study and Stability maintenance

(StarLIMS)

• Quality by Design (UPLC, HPLC, GC), Optimization, DOE (Six Sigma)

• In-house method, USP/EP method Justification & qualification

• APIs impurity profile, identification and Structure elucidation

• Process Technology Development, Optimization

• QC Regulatory updates and compliance

• Supervising/GMP guidance/Training and coaching.

• API Method development and validation (HPLC, GC)

• Analytical supports in synthetic process development

• Writing SOPs and analytical protocol and validation reports

2. Senior Scientist: January 2013 – August 2013

Missouri Analytical Laboratories, Inc., St. Louis, MO.

• Chromatographic testing and release of Drug Products

• Drug Products Stability Studies

• Evaluation of Multi dosage forms (Capsules, Tablets, Semi-solids, Liquids)

• Dissolution Studies (IR, ER Dosage forms)

• Chemical Characterization and release.

3. Senior Analytical Chemist I: May 2011 – September 2012

Upsher-Smith Laboratories, Inc., Minneapolis, MN

• Design and conduct experiments leading to the development and, or optimization of various

analytical methods for DS, DP, Vitamins, Fatty Acids, Minerals, new chemical entities,

recipients, intermediates, and finished products.

• Assist with and design experiments in order to solve difficult analytical challenges – method

development/validation, dissolution, stability study, set specifications and shelf-life of

nutraceutical (prescription) soft gelatin capsule products (lipid-based multi-

vitamins/minerals).

• Contributed successfully to the project as a core team member (lead analytical chemist) from

initial development to commercial lunches.

• Prepared and reviewed R&D documentation including specifications, analytical protocols

and reports.

• Participated in a cross functional team environment to support product development

activities and increase productivity of the analytical laboratory.

• Led all analytical activities (methods development, validation, CROs selection, outsourcing,

QC transfer, higher and manage junior chemists, etc.).

• Excellent communications and presentation skills for interactions with clients. Demonstrates

leadership and ensures project milestones and timelines are met.

4. SENIOR ANALYTICAL CHEMIST: 10/2009 - 02/2011

Novus International, Inc., St. Louis, MO

• Managed multiple projects simultaneously, communicate with clients, allocate resources

and resolve any unexpected issues to ensure agreed timelines

• Developed and validated analytical methods (HPLC, GC, LC-MS, NMR) to analyze

(Amino acids, fatty acids, anti-oxidants catechins, vitamins and sugars

• Provided full analytical supports to the clinical studies of Artinia and HT formulated

products

• Author SOP, test methods, method validation protocol/report, method development report,

and stability protocol/report, etc.

• Conducted forced degradation studies, impurity profiles, stability and commercial release

testing

• Elucidate the degradation products or impurities by LC-MS/MS and preparative

chromatography, NMR.

• Supervised an analytical team and provide technical training and problem solving guidance

to junior scientists

• Reduced OOS commercial products by leading several initiatives to improve product

quality

• Served as one-point contact with several CROs/CMOs

• Calibrated, maintained, troubleshoot and repair instruments

5. SENIOR RESEARCH CHEMIST: June 2004 - July 2009

Covidien, Inc. /Mallinckrodt Pharmaceuticals Inc., St. Louis, MO

• Provided extensive analytical expertise to the new APIs, drug product, stability study

• Headed new product analytical teams from method development to final validation

• Wrote reports, SOPs, Protocols and transfer methods to customers and other facilities

• Developed, validated and transferred robust HPLC & UPLC methods for assay release

• Successfully validated chiral HPLC methods for the resolution of APIs enantiomers

• Established LC-MS methods for new APIs and impurity identification

• Developed and validated new GC methods for OVIs analysis of new APIs

• Contributed in CMC/ANDA fillings

• Implemented Six Sigma tools (VOC, C&E, FMEA, G R&R, DOE, C P, for validation

• Established impurity profile through extensive studies of LC-MS and NMR tools

• Performed drug stability study, wet chemistry testing, dissolution study of drugs

NMR Expertise & Responsibilities:

Over 10 years of profession experience in NMR (500 MHz and 300 MHz) that applied to structure

elucidation of pharmaceutical molecules (APIs), impurities, new drug entities (natural products), peptides,

and chemical research and development.

• Structure elucidation and spectral assignment by NMR spectroscopy in support of a wide

range of pharmaceutical research and development.

• Maintenance of Bruker NMR instrumentation, including standard parameters sets, probe

files, shim sets and lock parameters, troubleshooting, meeting performance specifications and

calibration.

• Development of user-friendly, menu driven systems for spectrometer operation with

accompanying help files and instruction manuals. Instructing staff in instrument operation.

Black Belt Expertise (CDFSS: Chemical Design for Six Sigma)

• Successfully completed the chemical design for six sigma (CDFSS) training classes for

Black Belt Certification.

• Successfully passed the Op-Ex Black Belt CDFSS Examination.

• Applied CDFSS operation excellence tools to the analytical methods development for

analytical method development & validation projects.

6. Senior Analytical Scientist: January 2002 –June 2004; Chattem Chemicals, Inc.,

Chattanooga, TN

• Developed/validate and transfer analytical methods by HPLC and GC

• Elucidated impurity structures (DS/DP) by NMR, LC-MS

• Analyze drug products for potency, preservative, and impurity content by HPLC, UPLC and

GC

• Wrote reports for method transfers and method validation

• Performed dissolution testing on immediate and sustained release tablets.

• Performed content/blend uniformity and assayed on various drug forms: tablets, capsules,

liquids

• Developed, validated, performed cleaning methods (HPLC)

• Designed and d finished products on accelerated/long term stability study

• Calibrate laboratory equipment and instruments

• GMP peer reviewer

Fellowship Awards and Teaching

• University of Rhode Island (URI/NIH), Kingston, RI. 9/1996-5/1998

• University of Rhode Island (URI/NIH), Kingston, RI. 9/1996-5/1998

• Harbor Branch Oceanographic Institute, Fort Pierce, FL. 5/1998–12/2001

• Adjunct Faculty: Indian River Comm. College, Ft. Pierce, FL 9/1999-12/ 2001

• Adjunct Faculty: St. Louis Comm. College, St. Louis, MO 8/2010-12/ 2010

Education

• Ph.D. Chemistry, The University of Tokyo 1996

• M.S. Chemistry, The University of Dhaka 1990

• B.S. (Hones.) Chemistry, The University of Dhaka 1987

Citizenship

• United States of America (USA)

Selected Publication

• Paul G., Gunasekera S., Longley R. and Pomponi, S., Theopederins K and L. Highly potent

cytotoxic metabolites from a marine sponge Discodermia sp. J. Nat. Prod. 2002, 65, 59-61.

• Gunasekera S., Paul G., Longley R., Isbrucker R., and Pomponi S. Five New

Discodermolide Analogues from the marine sponge Discodermia sp. J. Nat. Prod. 2002, 65,

1643-1648.

• M. Murata, S. Matsuoka, N. Matsumori, G. Paul, K. Tachibana, Absolute Configuration of

Amphidinol 3, the First Complete Structure Determination from Amphidinol Homologues:

Application of a New Configuration Analysis Based on Carbon-Hydrogen Spin-Coupling

Constants. J. Am. Chem. Soc. 121, 870-871 (1999).

• G. Paul, N. Matsumori, K. Konoki, M. Murata and K. Tachibana, Chemical Structure of

Amphidinol -5 and - 6 Isolated from Marine Dinoflagellate Amphidinium klebsii and their

Cholesterol-dependent Membrane Disruption. J. Marine Biotechnology 5, 124-128 (1997).

• G. Paul, N. Matsumori, K. Konoki, M. Sasaki, M. Murata and K. Tachibana, Structure of

Amphidinol-3 and its Cholesterol-Dependent Membrane Perturbation: A Strong Antifungal

Metabolites Produced by Marine Dinoflagellate, Amphidinium klebsii : Harmful and Toxic

Algal Blooms. Intergovernmental Oceanographic Commission of UNESCO pp. 503-506

(1996).

• G. Paul, N. Matsumori, M. Murata and K. Tachibana, Isolation and Chemical Structure of

Amphidinol-2, a Potent Hemolytic compound from Marine Dinoflagellate, Amphidinium

klebsii Tetrahedron Letters 36, 35, pp. 6279-6282, (1995).

• M. Mosihuzzaman, G. Paul, N. Nahar, Analysis of Carbohydrate in Green Coconut Water

(Cocos nucifera.L), Journal: Dhaka University Studies, B, 41 (2) 113-118 (1993).

US Patents

• U.S. Patent Application Docket No. HB-30XC1. Biologically Active Analogs of

Discodermolide. Serial No. 09/796,175, February 28, 2001.

• U.S. Patent Application Docket No. HB-STS-31. Theopederins K and L Highly Potent

Cytotoxic Metabolites. Serial No. 60/197, 301. April 14, 2000.

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