NISAR H. AKBARI *

*** ***** ***** ***** ac3r50@r.postjobfree.com 636-***-**** (H)

Eureka, MO 63025 786-***-**** (C)

PROFESSIONAL SUMMARY

Results-driven versatile analytical chemist with broad experience in pharmaceutical industry ranging from early discovery to process and product development support for small molecules, peptides and biological drugs in Phase I through Phase III development.

Highly skilled in development, validation and transfer of analytical methodologies using FDA and ICH guidelines and guidelines provided by various pharmacopoeias.

Excellent analytical and problem solving skills and committed to continuous learning. Independently resolved technical issues that were crucial in developing and validating robust analytical methods for release testing of raw materials, in-process control and final products.

Extensive experience in HPLC/UPLC, IC, GC (including HS/GC), chiral separations, UV/Vis, IR, TGA, Karl Fischer, potentiometry, and classical wet chemistry methods. Some experienced in USP Dissolution Testing, capillary electrophoresis GC/MS, and ICP/MS.

Extensively interacted and coordinated with the cross-functional stakeholders of drug development teams at different sites for analytical method validation, stability of drugs, reference standard characterization, equipment cleaning validation, and establishment of specifications for raw material, intermediates and APIs.

Coordinated the preparation and review of analytical section of CMCs documents for U.S. and international NDAs.

Involved in periodic reviews and revisions of SOPs to ensure they conform to current and appropriate scientific, compendial and regulatory standards.

Successfully led the conversion of a non-GMP agrochemical laboratory at Monsanto into a pharmaceutical GMP lab.

Isolated the first reducing sugar, 1,6-dichloro-1,6-dideoxyfructose, a potential degradation product of Sucralose, to crystallize into keto-tautomeric form.

Experienced in fast pace Quality Control testing of in-process materials, and release and stability testing of Drug Substance (API).

Acted as technical resource and mentor for less experienced analysts on method transfer, method validation/verification and routine analytical support for manufacturing and provided training as needed.

Proficient with MS Windows, various chromatography data acquisition systems, LIMS and Electronic Laboratory Notebook (ELN).

PROFESSIONAL EXPERIENCE

Abbvie Pharmaceutical (Six Months Contract) Jan 2017 to Aug 2017

Chemist, Global Pharmaceutical Research and Development

Supported process development of new pharmaceutical chemical entities in pilot plant.

Used Electronic Laboratory Notebook to record the daily routine and non-routine work – no paper recording.

Kremers Urban / Lannett Pharmaceuticals 2015 to 2016

Chemist, Analytical Research and Development

Member of analytical team supporting DEA controlled USP drugs in development.

Successfully developed analytical method for a drug assay, and quantitation and identification of its ten expected impurities using non-conventional ion-pairing agent.

Developed and validated analytical method for the quantitation of genotoxic impurities in a drug (API) at trace level (0.001%) involving derivatization and HPLC separation.

Performed USP dissolution testing for in vitro drug release information on solid dosage forms.

Gallus/Patheon Biologics 2014 to 2014

Chemist (Contractor)

Member of analytical team supporting development of biologics.

Separated and collected heavy and light chain fractions of human coagulation Factor VIII for further identification using Gel Electrophoresis and HPLC/MS.

Demonstrated the cause of breakdown of Factor VIII into light and heavy chain during RP HPLC separation when using TFA in the mobile phase.

Mallinckrodt Pharmaceuticals, Narcotics and Peptide Process Development Support, and Peptide Quality Control 2008 to 2014

Sr. Research Chemist / Analyst IV

Developed and performed validation of analytical methods for narcotics and peptide drugs in preparation of Phase III and commercial manufacturing of API.

Verified USP and EP compendial methods for peptide drugs in compliance with the regulatory requirements of the US and the European market areas.

Performed gap analysis and drew attention of Quality Management to several deficiencies in the in-house methods and their validation. Revalidated methods per current regulatory expectations and industry standards.

Coordinated with various contract laboratories for the validation of analytical methodologies and routine analyses of peptide APIs.

Investigated out of specification (OOS) results to identify root cause and took appropriate corrective and preventive actions (CAPA).

Supported fast pace quality control testing of in-process, final products and stability samples of peptide origin.

Pfizer / Pharmacia, Inc. 2003 to 2008

Principal Scientist, Global Biologics, Analytical Research and Development

Developed and validated analytical methodologies for biologics (proteins and oligonucleotides) for assay, impurities, moisture, and appearance determinations per FDA, ICH and Japanese guidelines.

Developed strategy for equipment cleaning between production campaigns for two biological drugs of opposite therapeutic action. Investigated stability of the drugs in cleaning agents and investigated analytical technologies that could provide determination of trace residues on equipment with high sensitivity, accuracy and precision

Wrote and executed protocols, supervised preparation, distribution and control of reference standards for biological drugs.

Coordinated with Pfizer St. Louis, USA and Pfizer Nagoya, Japan for the preparation of analytical section of CMC for an ophthalmology drug (for AMD) for Japanese submission. Reviewed analytical summaries for accuracy and compliance with Japanese Pharmacopoeia (JP). Updated validation of analytical methods as needed in compliance with JP.

Pharmacia Inc / Monsanto Co. 1998 to 2003

Research Scientist, Process Development, Small Molecules, Analytical Research and Development

Managed analytical activities in support of API process development of drugs in commercial development.

Developed and validated analytical methodologies, including several chiral separations, for in-process control and release testing of critical raw materials and intermediates and to support process optimization for intermediates and APIs.

Facilitated analytical technology relocation from R&D to QC laboratories.

Performed non-routine investigations such as isolation and characterization of impurities, stability studies, solubility studies, and process troubleshooting.

Converted a Monsanto Agrochemical non-GMP process analytical laboratory into a Pharmacia Inc (then a recent acquisition by Monsanto) GMP analytical laboratory that supported chemical process development for new drug APIs.

Established and managed instrument calibration program.

Led the site analytical team on GMP and internal SOP compliance.

Facilitated SOP and GMP discussion sessions within the group as part of GMP training program.

Coordinated the development and revisions of standard operating procedures.

Hosted and responded to internal QA audits and took corrective actions as needed.

Hoechst Marion Roussel, Inc. / Sanofi-Aventis Pharmaceuticals 1993 to 1998

Associate Scientist / Project Analytical Representative

Managed analytical activities to support formulation development of a new drug and acted as analytical representative on the drug development team.

Collected and compiled analytical data and coordinated the preparation of analytical section of CMC for IND/NDA filings.

Developed low temperature (-10oC) HPLC method to quantitate four inter-convertible forms of a drug (diastereomers of the keto and hydrate forms) in the final product. The data was provided in response to an FDA inquiry about the company’s claim that the drug had the same efficacy regardless of its chemical form.

The NutraSweet Co. / G. D. Searle Co.

Research Analytical Chemist New Sweetener Research and Development

Developed methods for the evaluation of non-routine samples originating from chemical, microbial, and enzymatic research for the discovery and development of artificial sweeteners and macronutrient substitutes.

Evaluated purity, stability, and solubility of new compounds; purified and identified impurities and degradation products.

Investigated the separation of UV transparent organic anions and cations using low capacity anion and cation exchangers with indirect photometric detection. The research resulted in several outside presentations and publications, and resulted in the development of analytical methods for the determination of UV transparent analytes in new sweetener candidates.

EDUCATION

B. S. in Chemistry and Microbiology, University of Karachi, Pakistan

PROFESSIONAL SOCIETIES

Member American Chemical Society

NISAR H. AKBARI

PRESENTATIONS

A COMPARITIVE STUDY OF SEPARATION EFFECT USING CONVENTIONAL AND MONOLITH HPLC COLUMNS. Nisar H. Akbari and Jon P. Lawson. Presented at Pharmacia in TECH 2003 meeting in St. Louis, MO, Jun 2003

IPC METHOD DEVELOPMENT FOR 7 nAChR PROCESS USING HPLC/ELSD. Nisar H. Akbari and Mary P. Gasper. Presented at the Pharmacia TECH 2002 meeting in St. Louis, MO, May 2002

CHIRAL SEPARATION OF ALPHA-7 nAChR INTERMEDIATES. Nisar H. Akbari, Mary P. Gasper. Pharmacia TECH 2002 meeting, St. Louis, MO, May 2002

HPLC SEPARATION OF COMPOUNDS EXHIBITING INTER-CONVERSION BETWEEN DIFFERENT FORMS IN SOLUTION. Nisar H. Akbari, Mary P. Gasper and Jon P. Lawson. Pharmacia TECH 2001 meeting, St. Louis, MO, May 2001

THE SEPARATION AND INDIRECT DETECTION OF INORGANIC AND ORGANIC ANALYTE ANIONS ON A LOW-CAPACITY ANION EXCHANGE COLUMN. Nisar H. Akbari, Thanh V. Ho and Thomas Walker. International Ion Chromatography Symposium, Denver, CO. Oct. 1991

DICHLOROFRUCTOSE (DCF), A DEGRADATION PRODUCT OF SUCROLOSE. THE PREPARATION, REVERSED PHASE CHROMATOGRAPHIC BEHAVIOR AT SUBAMBIENT TEMPERATURE, AND THE STRUCTURE OF DCF. Nisar Akbari, Grant DuBois, Richard Mikulec and Michael Kellogg. Presented at the Monsanto Intercompany Analytical Meeting, G. D. Searle and Co., Skokie, IL, 1991

THE LIQUID CHROMATOGRAPHIC SEPARATION OF ORGANIC ANALYTE IONS ON LOW-CAPACITY ION EXCHANGE COLUMNS USING INDIRECT UV DETECTION. Thomas Walker, Nisar Akbari and Thanh Ho, The Pittsburgh Conference and Exposition on Analytical Chemistry and Applied Spectroscopy, Atlanta, GA, March 1989

PUBLICATIONS

COMPARISON OF SILICA-BASED STRONG ION EXCHANGERS AND LOW- CAPACITY POLYMER-BASED STRONG ION EXCHANGER FOR THE SEPARATION OF ORGANIC ANALYTE IONS USING INDIRECT UV DETECTION. Thomas Walker, Nisar Akbari and Thanh Ho, J. of Liq. Chromatogr, 14(4), 1991, pp. 619-641

THE ISOCRATIC SEPARATION AND INDIRECT UV DETECTION OF INORGANIC ANIONS AND MONO- AND DI-CARBOXYLIC ACIDS ON A LOW CAPACITY ANION EXCHANG COLUMN. Thomas Walker, Thanh Ho and Nisar Akbari, J. of Liq. Chromatogr, 14(7), 1991, pp. 1351-1366.

INDIRECT UV DETECTION OF ORGANIC ANALYTE IONS ON LOW-CAPACITY ION EXCHANGE COLUMNS. Thomas Walker, Nisar Akbari and Thanh Ho, Advances in Ion Chromatogr. Volume 2, Editor: Peter Jandik and Richard Cassidy, Century International, Franklin, MA, 1990, pp. 271-298.

INDIRECT UV DETECTION OF ORGANIC ANALYTE ANIONS USING A LOW-CAPACITY ANION EXCHANGE COLUMN. Thomas Walker, Nisar Akbari and Thanh Ho, J. of Liq. Chromatogr, 12(7), 1989, pp. 1213-1230.

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