Seasoned Pharmaceutical QC & Analytical Sciences Leader

**** ******* ** ***** ***** J. Rashmawi

Unit **

Surfside Beach South Carolina 29575

Summary

A Scientist with 30 years of experience in Pharmaceutical Quality Control and Analytical Services. My field experience is Pharmaceuticals, polymers, Vaccines, and Human Plasma Derivatives. My strengths are in Technical Management, Analytical Assay Development, Validation, R&D support analysis, and Assay/Instrument Validation

Professional History

Nephron Pharmaceuticals 2024-Present

Technical Supervisor, R&D Chemistry

Developed methods of analysis of pharmaceutical drug products by HPLC and LC/MS. Validated new analytical procedures following cGMP guidelines. Wrote Chemistry Test Methods (CTM) and Validation Protocols and Technical Reports. Maintained HPLC instrumentation, pH meters, Analytical Balances, and HPLC Columns.

August Bioservices 2022 - 2024

Principal Scientist

Develop new methods and optimize existing methods in Biopharmaceuticals for the analysis of drug substances and drug products for assay and impurities by LC/MS (QTOF), GC/MS, LC/MS (triple Quad), HPLC, and Infrared Spectroscopy. Special emphasis on Leachables and Extractables analysis.

Lancaster Laboratories, PSS at Eli Lilly 2014- 2022

Principal Scientist, Separation Group

Develop new methods and optimize existing methods in Small Molecule Design and Development for the analysis of drug substances and drug products for assay and impurities by GC/MS, LC/MS, HPLC, and Infrared Spectroscopy.

Bristol-Myers Squibb 2013 – 2014

Associate Manager/Scientist, QC Laboratory (Contract Position)

Solid Dose Quality Control, manage Dapaglyflozin, Daclatasvir, and Baraclude, QC Teams and assist in technical transfers of methods, validations, CMC document verification and approval, Clinical supply analysis, and general laboratory trouble shooting. Supervise 7 analysts.

NORAMCO, a Johnson and Johnson Company 2010 -2013

Supervisor Quality Control/Analytical Laboratory

Biological quality control evaluation of biological data. Manage analysis and reviews analytical test data and exception reports for conformity to quality standards. Recommend release or rejection of products based on scientific and industry standards, and practices. Oversee scientists in the department.

Develop HPLC, GC and GC/MS methods for the analysis and release of active pharmaceutical ingredients (Solid Dose) raw material, in-process, final product, and stability samples including residual solvents by GC, GC/MS, Headspace GC, HPLC purity, and HPLC active assay. Write and execute validation protocols for assays intended for Phase II and III clinical trials. Write analytical and cGMP standard operating procedures and train QC analysts on SOP’s, HPLC, and GC methods. Used HPLC, GC, LC/MS, GC/MS, FTIR, and UV/VIS spectrometers. Supervise 23 analysts.

Siemens Healthcare Diagnostics 2008-2010

Senior Manager Quality Control/PE

Managed a group of scientists in analysis of antibiotics and biochemical reagents used in a medical device for identification of bacteria and the evaluation of minimum inhibitory concentration of individual antibiotic compounds against clinical strains of bacteria and yeasts. Analyzed Clinical Supplies and verified documents for CMC. Used HPLC, Microscopes, UV/VIS spectrometers, LC/MS, ICP, and AA. Was responsible for In-Process testing, Clinical Supply release, Environmental Monitoring for particulate and viable count, and Ergonomics.

Phenomenex Inc 2006 – 2008

Senior Scientist/ QC Manager, Media Manufacturing

Managed a group of scientists in the analysis and characterization of silica particulate media used in HPLC resolution of organic and bioactive compounds. Measured surface organic load and resolution characterization of media batches. Used particle size distribution analyzers (Beckman Coulter Multisizer3), Mastersizer, LECO elemental analyzer (H,N,C,S) HPLC, ICP/MS, Microscopes,

Kamal J. Rashmawi 707-***-**** Page 2

Chiron Corporation, Biopharma Division 2001-2005

Associate Director QC/Validation

Manage a group of scientist in characterization of proteins and raw material for therapeutic proteins. Responsible for CMC documentation, assay transfers, validation of analytical methods and equipment per ICH guidelines, Assay Development, and general technical support for the Quality and Manufacturing Departments. Analyzed clinical supplies and assisted in INDA submissions.

Powderject Vaccines, Division of Chiron Corporation

Associate Director of Assay Development and Validation Services

Associate Director of Assay Development and Validation Services. Direct the activities of the Assay Development staff in developing biological and chemical assays for analysis of DNA vaccines, conventional vaccines, Antibodies, and proteins. Use the following instruments: UV/VIS spectrometers, Fluorescence Spectrophotometer, Atomic Absorption, HPLC, ELISA, and Endotoxin analysis kits. Write Validation protocols for the validation of QC assays according to GMP and ICH guidelines. Was responsible for CMC documentation and assisted in INDA submissions.

Served as bioanalytical and immunology lead for the development of DNA for vaccines against oncology targets (NY-ESO1), Flu, HSV, and other viruses in clinical and preclinical studies. Developed, validated in vivo and in vitro potency assays for GMP release of products. Supported the regulatory team and authored the CTA, IND analytical and quality sections. Led the analytical development team for product release and stability testing in collaboration with larger pharmaceutical (GSK) companies and government organizations in bioassay strategy beyond Phase I and II clinical trials on the IND/CTA regulatory filings. Technical presentations to management and external collaborators of the capabilities and new technologies developed in the lab. Provided pre-clinical toxicology support for GLP studies of DNA vaccines. Evaluated dose responses, expression profiling in dendritic cells after transfection and immune responses to various tumors and infectious antigens for potency release and biomarker assays.

Aventis Behring Pharmaceuticals 1997-2001

Group Leader, Analytical Development Department

Develop test methods for the analysis of finished products, raw material, and process samples of medicinal and biopharmaceutical compounds. Perform Method Validation and Development, Method suitability studies, transfer of methods from R&D to Quality Control, conduct OOS investigations, validate data in analysts notebooks and on LIMS, Train analysts, perform specification reviews,

and analyst performance reviews. Use instruments: HPLC, GC, Amino Acid Analyzer, GC/MS, AA, FTIR, UV/VIS Fluorescent Spectroscopy, Graphite Furnace AA, Capillary electrophoresis, and dissolution spectrometers. Write Validation protocols according to FDA, USP, EP, and ICH requirements. Execute validation protocols and report on method and system suitability. Follow cGMP guidelines in data and laboratory practices. Supervise 6 scientists.

Quantum Chemicals Corporation

1989-1997

Superintendent, Process Analytics

Manage process analysis Laboratory involved in method development for the analysis of polyolefin, ethylene, propylene, ethylene glycol, and Z-N catalysts. Developed and validated methods of analysis process streams and final products. Managed the department budget, overtime distribution, instrument specifications, and general personnel issues. Supervised 26 analysts. Used GC, HPLC, GC/MS, FTIR, AA, and ICP.

Education

B. S. Chemistry - Olivet Nazarene University, Kankakee IL

M. A. Analytical Chemistry -Governors State University, University Park IL

PHD- Illinois Institute of Technology, Chicago IL

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