Quality Control Development

Cornelius M. Williams

*** *********** ***** 919-***-****

Clayton, NC 27520 *************@*****.***

www.linkedin.com/pub/cornelius-williams/36/61b/957

QUALIFICATIONS SUMMARY

Expertise in development and validation of High Performance Liquid Chromatography/Ultra-

Violet Light Detection and Gas Chromatography/Flame Ionization Detection analytical methods;

Analytical research of synthetic topical and internal polymer adhesive formulations; Stability

evaluation of Schedule II and Schedule IV Controlled Drug Substances; and Performance

evaluation of metered dose inhalers (MDI), Class I and II medical devices and pharmaceutical

raw materials under GxP guidelines.

PROFESSIONAL EXPERIENCE

Catalent Pharma Solutions – MORRISVILLE, NC FEB 2013-PRESENT

Scientist, Pulmonary and Nasal Inhalation Research and Development Group

Responsible for stability evaluation of Nasal Inhalation and Oral Liquid Dosage Form products

• Evaluation of Nasal Inhalation Product stability via chromatographic analysis of Schedule II

and Schedule IV Controlled Drug Substances

• Generation of protocols, stability reports and certificate of analyses for stability studies.

Biogen Idec – MORRISVILLE, NC OCT 2011-FEB 2013

Quality Control Associate I, Quality Control-Raw Materials Group (Contract)

Providing analytical support for evaluation of pharmaceutical raw materials

• Raw material analysis following United States Pharmacopeia (USP) and European

Pharmacopeia (EP) monograph techniques (e.g., HPLC, GC, FT-IR, TOC, Specific Rotation,

LOD, Heavy Metals, pH and Titration, etc.).

• Standard Operation Procedure (SOP) generation for analytical lab equipment

Ethicon, Inc. – RALEIGH, NC JAN 2007-SEP 2011

Scientist, Applied Sciences and Technologies Group

Responsible for development, validation and implementation of Gas Chromatography, High

Performance Liquid Chromatography, Headspace and Mass Spectrometry methodology for

determining purity, impurities and related substances, residual solvents and extractables of

synthetic biosurgical adhesive and sealant products and processes.

• Developed, validated and implemented new Gas Chromatography methodology for

DERMABOND™ ADVANCED™ Topical Skin Adhesive to determine pre-polymer purity

and impurities content to support PMA 510K approval.

• Re-worked existing Ethicon™ OMNEX™ Surgical Sealant Gas Chromatography methods to

use new column technologies and stationary phases, which lowered data turnaround time and

annual consumables cost by 50%.

• Developed and implemented Gas Chromatography-Mass Spectrometry methods for

identification of related substances and impurities of Ethicon™ OMNEX™ Surgical Sealant

pre-polymer materials to support IND submission.

• Developed and implemented Headspace-Gas Chromatography- Mass Spectrometry methods

for identification of residual solvents in cyanoacrylate polymer materials and extractable

components of polyols.

CORNEL I US M . WI L L IA MS 919-***-****

PROFESSIONAL EXPERIENCE – continued

• Responsible for transfer of new technology and methodology between Research and

Quality Control, quality control employee training.

• Provided analytical support for stability analysis, root cause analysis and complaint

investigations for synthetic polymer formulations and medical devices.

• Provided preventative maintenance of Agilent 6890 Gas Chromatographs and Shimadzu QP-

2010Plus and LCMS-2010EV Mass Spectrometers.

Closure Medical Corporation– RALEIGH, NC MAY 2005-DEC 2006

Associate Scientist, Product Development Group

Responsible for qualification and validation of Gas and High Performance Liquid

Chromatography methods, investigation of product complaints and stability analysis of

cyanoacrylate formulations according to current GMP guidelines.

• Developed, validated and implemented High Performance Liquid Chromatography

methodology to facilitate identification of cyanoacrylate polymer water extractables and

degradation products.

• Supported development and implementation new Gas Chromatography methodology

for Liquid Johnson & Johnson Band-Aid® Liquid Bandage for Johnson & Johnson

Consumer products

• Support development and implementation of Gas Chromatography methodology for Liquid

DERMABOND ™ and DERMABOND Mini™ Topical Skin Adhesive to determine pre-

polymer purity and impurities content.

Cardinal Health – MORRISVILLE, NC JULY 2002-MAY 2005

Chemist II, Pulmonary and Nasal Inhalation Group 2003-2005

Responsible for stability evaluation of Active Pharmaceutical Ingredients (APIs), Controlled

Drug Substances and lyophilized drug products, performance evaluation of pressurized Metered

Dose Inhalers (pMDI) and Dry Powder Inhalers (DPI) and generation of reports and Certificate

of Analysis for investigational studies and stability programs.

• Performed verifications of dosage concentration and dose content uniformity for controlled

drug substances and lyophilized drug products using Anderson Cascade Impaction, filter

extraction and HPLC analysis techniques.

• Supported verification and implementation of methodology for determination of Impurities

and Related Substances by HPLC.

• Supported development and implementation of a Gas Chromatography method for

determining the Ethanol content of a controlled drug substance.

• Provided analytical support for stability analysis and root cause investigations including

forced degradation and particle size distribution analyses of a controlled drug substances and

dry powder inhalants.

• Responsible for peer data review and new employee training concerning GMP/GLP

guidelines and internal testing procedures.

Chemist, Raw Materials Group 2002-2003

CORNELIUS M. WILLIAMS

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Provided analytical support for stability evaluation of pharmaceutical intermediates and

controlled drug substances and compendia testing of drug product raw materials following USP,

EP, and JP monograph techniques.

• Performed Compendia testing of drug product raw materials following USP and EP

monograph techniques (e.g., HPLC, FT-IR, Heavy Metals I, Heavy Metals II, Moisture, pH

and acid number titration, LOD and ROI, etc.).

EDUCATION

Bachelor of Science, Chemistry (2001)

Minor, Zoology (2002)

North Carolina State University – Raleigh, NC

ACHIEVEMENTS

4-Year Letterman on North Carolina State University Men’s Basketball Team 1997-2001

PROFESSIONAL DEVELOPMENT

Analysis and Interpretation of Mass Spectra short course, American Chemical Society (ACS)

Interpretation of Mass Spectra short course, LC Resources Inc.

Polymer Chemistry: Principles and Practice short course, American Chemical Society (ACS)

Effective Technical Writing, American Chemical Society (ACS)

TECHNICAL PROFICIENCIES

Technical Skills: Standard Operating Procedure (SOP) generation, Protocol and

Technical Report writing; Data Review, Minitab, Excel, PowerPoint

and MS Word

Analytical Techniques: GC, HS-GC, GC/MS, HPLC, LC/MS, UV/VIS, TGA, DSC and FT-

IR

Mass Spec Operation, trouble-shooting and maintenance of Shimadzu QP-

Instrumentation: 2010 Plus MS, Operational knowledge of LCMS-2010EV

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