Senior Scientist

Robert E. Roberts IV

Durham, NC • 919-***-**** • *************@*****.***

PROFESSIONAL PROFILE

Senior analytical chemist with 15+ years of proven success in the pharmaceutical industry providing support

for the development of products for the eventual submission to and approval by regulatory agencies such as

the FDA. Motivated, energetic, collaborative critical thinker recognized for excellent project progression and

organizational skills.

CORE COMPETENCIES

Analytical Testing Authoring Stability Protocols Ability to Leverage Analytics to

Generating Stability Data Data Compilation and Inform and Drive Decisions

Formulation Support Presentation Individual and Team Contributor

Method Development Project Planning and Conducting Testing Technique

Method Validation Management and Instrument Training

HPLC Analysis Data Review Process Improvements,

Automated Testing Platforms GMP Requirements Simplifications and Efficiencies

Authoring Analytical Methods Problem Solving Strategic Thinking

PROFESSIONAL EXPERIENCE

GlaxoSmithKline, Research Triangle Park, NC 2001 - Present

Emerging Markets R & D 2012 –

Present

Senior Scientist, March 2012 - Present

Accomplishments:

• Provide analytical support of formulations for new pharmaceutical products intended

for clinical and commercial use.

• Provide analytical support for stability studies of new pharmaceutical products intended

for clinical use.

• Perform analytical techniques including content, impurities, moisture content by Karl

Fischer, dissolution, HPLC.

• Develop analytical methods for the testing of new pharmaceutical products.

• Develop analytical methods for the analysis by high performance liquid

chromatography of prepared samples of new pharmaceutical products.

• Design and author protocols for and perform the validation of developed analytical

methods against phase appropriate criteria.

• Design, author protocols for, and manage formal and informal stability studies in

support of shelf life determination and for clinical supply manufacture.

• Author analytical methods and specifications.

• Compile and interpret data for presentation to the project team in order to make

decisions on project progression.

• Conduct review of experiments and data.

• Troubleshoot and maintain equipment to cGMP standards.

Recognition:

• July, 2014 – Bronze level award for project contributions enabling the progression to a

first pK clinical study

March, 2013 – Bronze level award for project contributions enabling the progression to

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a pilot bioequivalency clinical study

Pharmaceutical Analytical Center of Excellence (PACE) 2001 – 2012

Senior Scientist, Apr 2009 – Present

Scientist, Sep 2004 – Apr 2009

Assistant Scientist, Sep 2001 – Sep 2004

Accomplishments:

• Provided analytical support for formal stability studies of new inhaled products (MDI

and DPI) intended for clinical and commercial use.

• Provided analytical support for investigational studies involving formulation

adjustments, new actuator devices, and analytical method revisions.

• Performed analytical techniques including particle size distribution by cascade

impaction (ACI and NGI), emitted dose, content, impurities, HPLC.

• Managed and coordinated testing for stability studies of new inhaled products (MDI

and DPI) intended for clinical and commercial use.

• Compiled and interpreted stability data for presentation to the project team in order to

make decisions on project progression.

• Provided analytical support and study design for the qualification of automated

platforms used in the testing of inhaled products, both MDI and DPI.

• Provided analytical technique training to new analysts.

• Provided training for the use and operation of automated platforms for inhaled product

testing.

• Provided analytical support for investigational (DoE) studies of an MDI product

involving device changes, actuator changes, and formulation adjustments.

• Conducted review of experiments and data.

• Managed equipment to ensure compliance with cGMP requirements.

Recognition:

• August, 2012 – Bronze level award for contributions made to project progression,

specifically management of stability protocols and data compilation to achieve decision

milestone.

March, 2010 – Bronze level award for project support in identifying a formulation and

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packaging configuration to achieve a 24 month shelf life and management of scale-up

stability and automation validation.

March, 2009 – Bronze level award for delivery of project against an aggressive timeline

•

achieved through technical problem solving around equipment issues.

October, 2008 – Bronze level award for support of the successful sNDA submission of

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an MDI product, and for the implementation of automation.

September, 2008 – Bronze level award for completion of an automation platform

•

qualification study under an aggressive timeline in order to be used for the launch of an

MDI product with a counter actuator.

January, 2008 – Bronze level award for contributions made to sNDA submission of an

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MDI product with a counter actuator.

August, 2007 – Exceptional Science award for the determination of the cause of high

•

failing end of use results being generated by an outside CRO. Recognition of good

problem solving skills in identifying differences in the testing procedure that led to the

failing results. Once determined, no further failing results were generated.

December, 2006 – Bronze level award for the development and implementation of a

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design for a high throughput cascade impaction testing lab. Incorporated factors such

as layout, sample flow, equipment, and ergonomics.

May, 2006 – Bronze level award for contributions made to the FDA submission of an

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MDI product, specifically around development pharmaceutics testing and

troubleshooting differences in cascade impaction testing performed by GMS.

August, 2005 – Exceptional Science award for the implementation of inhaled

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automated platforms into the testing process for cascade impaction as a lead user and

trainer, utilizing lean lab concepts and increasing productivity.

June, 2003 – Bronze level award for support of and contribution to method

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development and qualification of inhaled automated platform for use in routine testing

and data generation.

Blue Ridge Pharmaceuticals Inc., Durham, NC

Analytical Chemist (March 2000 – September 2001)

Accomplishments:

• Provided analytical support for new pharmaceutical products intended for clinical and

commercial use.

Contributed to the set up and operation of a lab facility in Durham, NC for the analytical

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testing and stabililty storage of pharmaceutical products.

Authored documents required for the set up and maintenance of analytical equipment

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to cGMP requirements including SOP’s, IQ, OQ, and PQ procedures.

Authored analytical methods.

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Provided analytical support for stability studies of pharmaceutical products intended for

•

clinical and commercial use.

Conducted review of experiments and data.

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Magellan Laboratories, Morrisville, NC

Chemist III (March 1993 – Mar 2000)

Accomplishments:

Provided analytical support for stability studies of various pharmaceutical products

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(solid dose and inhaled).

Provided analytical support for drug substances and drug intermediates.

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Performed analytical techniques including content, impurities, moisture content by Karl

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Fischer, dissolution, HPLC.

Provided analytical technique training for new analysts.

•

Conducted review of laboratory notebooks and data.

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EDUCATION

May 1991 - Bachelor of Science in Chemistry

North Carolina State University – Raleigh, North Carolina

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