Michelle Patrice Law, PhD

201-***-****

Email: acg2sz@r.postjobfree.com

I am residing in California as of 06/01/2014

My training includes:

. Applied microbiological and immunological assay development, design,

validation,

. cGLP, cGMP, Quality Assurance and Compliance.

. 'gap' and risk assessments as part of enhancing and strengthening the

corporate Quality

. Compliance programs with specific focus on Microbiological Safety

. design and execution of studies to assess the validity of the newly

developed assays within the established laboratory methods

. assay troubleshooting and microbiological method development of consumer

products (sterile and non-sterile),

. Phase I-III pharmaceuticals (Rx and OTC) studies, NDA, BLA, MAA

submission writing and the interpretation and translation of US FDA

regulations and practices related to both pre-and post-market activities

for Class I-III medical devices.

. Experience in FDA Human Tissues, and Cellular and Tissue-Based Products

(21 CFR part 1271)

. Reviewing, writing and validating testing and environmental monitoring

protocols according to regulatory guidances and applicable international

standards.

. assessment of manufacturing environments for their suitability to

produce quality regulated products (especially from a microbiological

safety position)

. preparation for ISO and FDA audits as well as the CAPAs needed to

address any observations

. Overseeing the execution of those validation activities with the review

of data and the writing of experimental reports.

Specialties:

. Microbiological Safety of Class I-III medical devices, pharmaceuticals,

combination products & consumer products.

. bio burden, sterility and biocompatibility including strong experience

with ISO 1099-3 and FDA guidance G-95),

. cGLP and cGMP,

. Quality Auditing,

. analytical assay development & validation

. FDA pre-market clearances, Post-Market surveillance,

. Risk assessment, Kaizen facilitation, and SOP development.

PROFESSIONAL EXPERIENCE Technical Director, Microbiology-contract

Quest Diagnostics Laboratories

Greater New York City Area

05/20/2013-05/20/2014

I served as the resource (liaison) to physicians, clients and internal

personnel by responding to technical inquiries. Additionally, I oversaw

quality, instrumentation and automation in the microbiology laboratory as

well as provided support to the network laboratories by undertaking reagent

and instrument evaluations. I was also responsible for the validity,

accuracy, analysis of all testing performed in the laboratory by enhancing

current or suggesting new methodologies. I have implemented a process in

the laboratory that has eliminated discrepant results and corrected reports

to clients. I have started a program for positive culture reporting

providing clients with information needed for epidemiological studies. I

determine and develop departmental technical standards and insure strict

adherence to quality control programs.

Further, partnering closely with both the Medical and Laboratory Directors,

I provided technical, medical and operational direction to the business

unit. I assisted in the interpretation of FDA regulations and procedures in

the marketing of medical devices as well as in the writing review of IVD

(Class II) submissions to the FDA.

Microbiologist & Technical Leader

Kimberly-Clark Corporation, Global Medical Device & Consumer Product Safety

Greater Atlanta, Georgia Area

02/28/2011-02/28/2013

I was responsible for providing the technical expertise for the development

and maintenance of a comprehensive microbiological safety program for

medical devices and consumer products. These activities included; the

writing of and managing the execution of analytical protocols and methods

to address potential risks to product safety, ensuring that methods are

established and validated, writing of microbiological safety assessments

for current as well as new and innovative products. This allowed Kimberly-

Clark to perform screening of products 'in-house' rather than sending them

out to a contract laboratory, resulting in cost savings for each medical

device requiring such testing. As a result of my risk and safety

assessments, the Health Care Division's product development teams were

better positioned to project medical device design in order to minimize any

foreseen risks thereby keeping the marketing deadline on track.

Additionally, I provided expertise and input for the development of novel

products that would involve a microbiological component, trouble shooting

and assessing product complaints directly related to contamination and

other microbiological safety issues. I assisted in the translation of FDA

regulations and procedures in the marketing of medical devices,

participated in design control meetings as well as in the writing and

review of Class II & III medical device submissions to the FDA. Further, I

was responsible for writing and publishing position papers related to KC's

position on specific aspects of microbiological safety as it relates to

medical devices and consumer products auditing contract laboratories for

compliance to cGLP and providing regulatory support where needed to assist

in 'go to market' timelines.

Microbiologist & Regulatory Scientist &Acting Branch Chief

FDA (Food & Drug Administration)/CDRH Greater Washington, DC Area

03/04/2007-03/02/2011

Responsible for the review of pre-market submissions from the

pharmaceutical & medical device industry to determine the safety

(sterility, biocompatibility and anti-microbial) of medical devices for

approval and clearance.

Review applications to conduct investigation clinical studies of unapproved

medical devices under the

IDE program, 510 (k)[Class II], and PMA[Class III] and HDE programs for pre-

market approval and clearance using 21

CFR, scientific expertise, ISO and other international standards.

Additionally, my experience includes serving as a consulting scientist to

assess the safety and efficacy of in vitro diagnostic devices; primarily

those indicated for use in the detection of antibodies to or surface

components of microorganisms. My duties also included serving as a

consulting scientist for the Office of Compliance during field action (post

market) inspections when those activities required a SME (subject matter

expert) in the field of microbiology.

Review and initiate petitions for the reclassification of devices based on

21 CFR, guidances and historical precedence. Interact (face to face,

teleconference and submissions) with and provide support to industry y and

advisory panels which make recommendation on FDA actions regarding selected

devices, and conduct continuing reviews, surveillance, and medical device

labeling and clinical experience.

POST DOCTORAL RESEARCH FELLOW

The University of Michigan, Ann Arbor Department of Pathology

Ann Arbor, Michigan

10/04 - 08/06

Research activities included in vitro diagnostic method development using

hematological as well as immunological methods as part of the development

of a diagnostic platform that would detect immunological markers that could

possibly serve as diagnostic indicators for sepsis.

These assays include but are not limited to protein chemistry methodologies

(electrophoresis, ion exchange, affinity and size exclusion chromatography,

western blotting, GC Mass Spectroscopy and MALDI TOF), ELISA performance

and development, protein microarrays, molecular biological techniques

(northern, southern, southwestern blotting, gel shift assays, DNA

sequencing, PCR and RT PCR), tissue culture, cell separation techniques and

flow cytometry. Small animal surgeries and post- surgical care and protein

microarrays to assess cytokine levels in septic mice, hematology and

chemistry methods were developed and used to assess multiple organ damage

as a result of sepsis. Designed and developed an ELISA assay for cystatin

C.

* Laboratory required strict adherence to c GLP regulations

* Collect, organize and analyze large data sets using basic computer

techniques and statistical software

* Exercised independent judgment for interpretation of data to be discussed

with principal investigator

* Write reports on experimental findings

* Prepare posters, presentations and write abstracts (see Publications and

Posters)

EDUCATION

HOWARD UNIVERSITY, WASHINGTON, DC Doctor of Philosophy, December 2004

Major: Microbiology

Title of Dissertation: Characterization and Effects of an Eosinophilic

Granular Protein and selected cytokines (IL 4, IL 10, IL 12 and TNF-?) on

Breast Cancer Cell Growth.

The California State University at Fullerton

Bachelors of Arts, June 1997

Major: Biology

PUBLICATIONS

. Eosinophil major basic protein (MBP) and tumor necrosis factor alpha (TNF

?) inhibit prostate Multi- cellular spheroid (MTS) growth. Proc Amer Assoc

Cancer Res, Vol 47, 2006

. Characterization and Effects of an Eosinophilic Granular Protein and

Selected Cytokines (IL-4, IL-10,

IL-12, and TNF ?) on Breast Cancer Cell Growth. Journal of Interferon &

Cytokine Research

26:63-70, 2006

. Hemoconcentration and Increased cytokine profiles in non-resuscitated

sepsis. SHOCK, Vol 23, 2005

. Deadly Diseases and Epidemics: Breast Cancer ISBN 078********** Chelsea

House Publishers, U.S

15. Sept 2006

. Bio-burden rationale for non-sterile products, a Kimberly-Clark internal

White Paper. 2012

REFERENCES

Steven R. Camp, VP of Clinical, Regulatory Affairs & Product Safety, KC

Global Sales, Kimberly-Clark

Corporation. 770-***-****; acg2sz@r.postjobfree.com

Lynne Radziwill, Director of KCP Regulatory Affairs & Quality Assurance, KC

Innovation, Kimberly- Clark Corporation. 770-***-****;

acg2sz@r.postjobfree.com

Dr. Herbert Lerner, Deputy Clinical Director, Division of Reproductive,

Abdominal and Radiological

Devices (US FDA/CDRH/ODE); 301-***-****. acg2sz@r.postjobfree.com

Mr. Johnny Mercer, Quality Program Leader, Global Quality Assurance,

Kimberly-Clark Corporation. +1-770-***-****, acg2sz@r.postjobfree.com

Ms. Cheryl Sanzare, Director, Global Regulatory Affairs, Kimberly-Clark

Corporation. acg2sz@r.postjobfree.com, 770-***-****

Dr. Shu-Ping Yang, Medical Director, Health Care, Global Clinical Affairs,

Kimberly-Clark Corporation.

+1-770-***-****. acg2sz@r.postjobfree.com

Dr. Christina Goode, Professor of Biochemistry and Director of the Office

of Health Professions, California State University at Fullerton.

acg2sz@r.postjobfree.com; 657-***-****.

Contact this candidate