Product and Process Development

LORRAINE SCOTT

North Wales, PA 267-***-**** ********@*******.***

Senior Scientist

Accomplished, results-driven scientist with over 10 years of experience in

the pharmaceutical and medical device industries. Skilled at developing and

improving products/processes in support of regulatory submissions,

identification of critical process parameters, process scale-up and method

transfer. Designed, analyzed and characterized experiments and provided

problem solving expertise to internal and external partners. Highly

organized and adept at report writing; key contributor with the ability to

collaborate with cross-functional teams to ensure the completion of

projects that meet customer/business needs.

Core Competencies

Communication

Scientific/Technical Writing

Cross-Functional Team Collaboration

Research & Testing

Product/Process Development

Organization & Time Management

PROFESSIONAL EXPERIENCE

Product and Process Scientific Solutions (Keystone Green Contractor),

Spring House, PA

Scientist II Oct 2011-Jul 2013

As part of a team provided solid-state characterization and analytical

analyses to support regulatory submissions and resolve product development

challenges, out-of-specifications (OOS) and non-conformance issues across

all areas of J&J: pharmaceutical, consumer, and medical devices.

. Characterized samples using Fourier Transform Infrared (FTIR)

Spectroscopy and Nuclear Magnetic Resonance (NMR) to determine any

compositional variability between lots. Prepared and submitted a

report to the client summarizing the results from all characterization

activities, including the work from other group members.

. Evaluated and characterized over 200 samples related to a major non-

conformance investigation to determine the root cause of the event and

identify corrective/preventative measures or deviations; documented

testing in laboratory notebooks, analyzed and interpreted data, and

reported results in written reports. Coordinated work with other team

members to ensure all samples were tested in a timely fashion and/or

establish plans for additional testing if needed. Prepared and

maintained an inventory of all incoming samples on the SharePoint

site.

. Validated test methods and evaluated particulates generated during

acute fatigue testing of stents using light obscuration (LO) and FTIR.

. Co-wrote protocol and executed dissolution experiments to evaluate the

influence of water on the drug release profile and morphology of

hormone patches.

. Authored 18 study reports, plus a design summary describing the

results of all characterization activities completed in the

development and optimization of a stent-graft system. All reports were

accepted by QA with no requests for clarification or additional

information.

. Trained new personnel on the use of laboratory equipment and

procedures.

. Assisted in the preparation of change control documents.

Cordis (A10 Contractor), Spring House, PA

Scientist II Apr 2009-Oct 2011

Characterized polymeric formulations using USP and regulatory approved

analytical methods to ensure a rapid and successful launch of new products.

. Performed and documented testing required for regulatory filings

according to published standards.

. Co-wrote and executed study protocols to characterize the in vitro

degradation of PLGA (poly(DL-lactide-co-glycolide) in drug-eluting

stents using gel permeation chromatography (GPC), microscopy, and

light obscuration; reported results in monthly status reports and

PowerPoint presentations, as well as wrote study reports.

. Reviewed laboratory notebooks and assisted in preparations for a

regulatory audit.

. Validated test methods used in degradation and stability studies to

ensure data quality and integrity.

. Evaluated the durability of the hydrophilic coating on stents using

micro-flow digital imaging.

. Conducted a stability study to determine the effective levels of

biocides in the testing media, and the degradation products generated

during chronic fatigue testing of stents.

Johnson & Johnson Pharmaceutical Research and Development, Spring House, PA

Senior Scientist Jan 2002-Mar 2008

Developed new and/or improved commercially viable processes to advance

medicinal candidates through preclinical and clinical development while

minimizing time to product launch.

. Eliminated costly reagents and improved the efficiency of a final

coupling step of a pyrazole intermediate, leading to a 30% reduction

in the cost to prepare drug substance. Liaised with CRO to supply

starting material for GMP campaign and prepare a project summary.

. Contributed to an improved process for the synthesis of a glycoside

derivative. Prepared key intermediates and developed a purification

and crystallization procedure for final product, which streamlined the

previous process, resulting in a 25% cost savings. Successfully

transferred process/technology to other parts of R&D, and partner CMOs

for scale-up. Participated in the creation and review of process

patent.

. Served as Chemical Development representative on Vascular Research

Team to facilitate the transfer of projects from Drug Discovery to

Chemical Development and minimize the product development timeframe.

. Collaborated with CMC (Chemistry, Manufacturing and Controls) leaders

to determine development strategy and ensure a rapid and successful

launch of new products.

. Developed a resolution/racemization procedure for a key intermediate.

Described procedure in an article entitled "Crystallization-induced

Asymmetric Transformation of p-Chlorophenylalanine Methyl Ester",

published in Tetrahedron: Asymmetry, 1998, 9, 3247.

. Contributed manuscript "1,1,2,3,3-Pentaisopropylguanidine" to

Encyclopedia of Reagents for Organic Synthesis. Paquette, L.A., Ed.;

John Wiley & Sons, New York, 1995.

. Key contributor to the development of a liquid phase peptide

synthesis; performed critical couplings with minimal protection,

thereby reducing cost to prepare peptide by 15%; co-authored

publication. Team received the Johnson & Johnson Award for

"Development of Azaline B".

. Played a key role in the development of a second-generation synthesis

of a sulfamate derivative, resulting in a 50% reduction in the cost to

prepare drug substance. Prepared two separate reports on the new and

old processes and transferred methodology for scale-up. Organized and

presented a complete overview of the project at the Annual Chemical

Process Development Meeting. Co-authored process patent. Received the

J&J Achievement Award for "Development of Topiramate Process" and the

Optimus Award, a peer nominated/committee selected company award, for

significant achievement in the development of the process.

. Collaborated with external manufacturing site to develop a continuous

process to manufacture drug substance.

. Identified and isolated a unique process impurity that was used to

determine infringement of a process patent, thereby preserving the

company's market share. Received the J&J Achievement Award for work.

EDUCATION

M.S. Chemistry, North Carolina Central University, Durham, NC, 1982

B.A. Chemistry, University of North Carolina, Chapel Hill, NC, 1979

TECHNICAL SKILLS

Laboratory: DSC, FTIR, LO, MFI, GPC, HPLC, NMR, LC-MS, GC and UV-Vis

Computer: MS Office, Adobe Acrobat, SharePoint, SciFinder, Omnic,

PharmSpec, ChemDraw, Prism, LIMS, Empower

AWARDS AND HONORS

2001 The J&J Affirmative Action/Equal Opportunity Team Award

1998 PRI Significant Achievement Award for the RWJ-270201 Synthesis Team

1997 Johnson & Johnson Award for "Development of Azaline B"

1992 Johnson & Johnson Achievement Award for "Development of Topiramate

Process"

1991 Johnson & Johnson Achievement Award for "Tolmetin Patent Protection"

1989 R.W. Johnson Pharmaceutical Research Institute's Optimus Award

PUBLICATIONS AND PATENTS

13 Articles in peer reviewed journals

1 Reagent for the Encyclopedia of Reagents for Organic Synthesis

5 Patents

PROFESSIONAL ORGANIZATION

American Chemical Society

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