Manager Product Development

Curriculum vitae

Sharmini S. Muralitharan (nee Soosaithasan)

Fremont, CA

510-***-**** (Cell)

E-mail: *********@*****.***

Career Summary: Several years of product development experience in the

medical devices, in vitro diagnostics industry. Track record of project

management and focus on on-time product delivery. Excellent crisis

management skills. Experience in successfully adapting to fast-pace

environments.

Professional Experience:

2004-Present: Product Development Manager (2006-present)

Thermo Fisher Scientific, (formerly Lab Vision Corporation)

Fremont, California

. Site Leader for product development

. Responsible for the direct supervision of multidisciplinary

product development team (including MD and PhD level

scientists)

. Implemented product development QCF & PWI in compliance

with ISO 9001, IVDD directive & 13485 systems

. Manage product development project timelines and lead PACE

and R&D review meetings

. Participate in various stages of product development -

generate manufacturing instructions, SOP, product launch

documentation, product inserts & MSDS, product registration

ex-US

. Manage external product evaluation sites, and collaborate

with opinion leaders on special projects

. Key member of FDA and ISO site audit teams

. Lead software validation projects to assist in instrument

product development team

Technical Support Manager (2009-2010)

. Responsible for direct supervision of technical support

team

. Conduct monthly CAPA meetings, trend complaints & recommend

corrective actions to the responsible departments

. Guide R&D team in product quality improvement projects

. Close-out customer complaints regularly and provide

guidance to technical support team in responding to

customer inquiries

Business Development Manager (2004-2007)

. Responsible for the direct supervision of Web

Administrator, and EH & S Specialist

. Identify, establish and manage strategic partnerships, with

OEM customers, and establish OEM pricing policy

. Analyze market trends, customer requirements,

competitive strategy,

and identify opportunities for product differentiation

. Product Manager for life sciences research reagents and

microarray product line

. Write technical product literature, brochures, training

materials and website content for internal and external

portals

. Lead on annual product rationalization team and catalog

project

. Provide guidance to internal team working on translation of

product inserts and/ or user manual and assure timely

delivery to distributors

. Attend tradeshows to present scientific

posters, and gather market intelligence

. Train product specialist

On-site integration lead

. Ensured timely transfer of technology between sites and

implemented PWIs for operations

. Trained customer facing teams on the new technology;

continued to provide product support and post launch

monitoring

2002-2004: Technical Sales Manager, OEM Accounts

Life Technologies Inc., (formerly Zymed Laboratories), South

San Francisco, California.

. Product Manager for tissue microarray product line, provide

technical support to key accounts, and generate technical

literature

. Liaison between marketing & production on OEM orders,

ensure timely product delivery to key global OEM accounts

. Participate in developing and maintaining key accounts,

partnership & collaborations

. Identify customer needs and provide technical

sales/marketing support, and solutions

. Negotiate contracts with OEM customers

. Represent company at Vendor Shows & Conferences

Management Training:

. Practical Process Improvement Training

. Dale Carnegie Leadership Training for Managers

. Role Mode Leader Training

. Role of Leader Training

Education:

Post Doctoral: Yale University School of Medicine, Section of Comparative

Medicine, Connecticut 2000

Advisor: Dr. Felix Homberger

Ph.D.: Marshall University School of Medicine, Huntington, West Virginia

1998

Graduate Research Assistant, Department of Microbiology, Immunology and

Molecular Genetics

Advisor: Dr. Donald Primerano

B.S.(cum laude): Marshall University, Huntington, West Virginia

1992

Major: Biology; Minor: Chemistry

Technical Expertise:

. Molecular Biology: pcr/rt-pcr, Cloning/ Subcloning genes and promoter

sequences, Restriction Mapping, DNA/ RNA Extraction, Automated

Sequencing, Agarose gel analysis

. Bacteriology & Protein Purification: Maintaining/ Propagating bacterial

cultures for plasmid preparation, Recombinant Protein Expression,

Affinity Purification, SDS-PAGE gel analysis and Western Blots, Mobility

Shift Assays, 32P labeling of Oligonucleotides, Autoradiography

. Yeast Genetics: Reporter Construction, Yeast transformation, Maintaining

yeast in selective media, (-galactosidase assays, Construction of One-

hybrid System

. Virology: Maintaining Mammalian Cell Cultures (multiple strains),

handling virus infected cultures and Viral RNA Extraction

. Computer Skills: PageMaker, Adobe Illustrator, Photoshop, PowerPoint,

Microsoft word, Excel, Genepro 4.0, Oligo 4.0, Sequence database

searches.

Teaching Experience:

Graduate Teaching Assistant for Molecular Biology laboratory course (1995 -

1997)

Tutor for medical students in Biochemistry (1994 - 1995)

Mentor for High School minority students (1994 - 1998)

Mentor for undergraduate students, Marshall University (1995 - 1996)

Honors & Awards:

Career Enhancement Award for West Virginia Women and Minorities in the

Sciences (1996 - 1998) Co-sponsored by the National Science Foundation

National Dean's List (1994 - 1996)

Marshall University Graduate Assistantship (1993 - 1998)

Marshall University Dean's List (1990 - 1992)

International Student Tuition Waiver Award (1991)

Marshall University Int. Student Award (1990 - 1991)

Publications:

1. Soosaithasan, S. S.; Jewell, R. D.; Primerano, D. A.

Characterization of an upstream regulatory sequence of SPR1(SSG1),

a late sporulation-specific gene.

Presented at: Yeast Genetics and Molecular Biology Meeting, August

6-11, 1996, at The University of Wisconsin, Madison, Wisconsin.

2. Soosaithasan, S. S.; Jewell, R. D.; Primerano, D. A. Analysis of

the promoter region of the late sporulation-specific gene SPR1 in

Saccharomyces cerevisiae.

Presented at: The Tenth Annual Research Day 1997, March 4, 1997,

Barboursville, West Virginia

3. Soosaithasan, S. S. and D. A. Primerano. Regulation of the late

sporulation-.

specific gene SPR1 (SSG1) by a composite promoter. Presented at:

The Eleventh Annual Research Day 1998, April 7, 1998, Huntington,

West Virginia

4. Chris M. van der Loos, PhD; Frank Yuan, DVM, PhD; and Sharmini

Muralitharan, PhD. Development of a one-step polymer based double

staining system for immunohistochemistry. Presented at: National

Society for Histotechnology 2007, Oct. 28, 2007, Denver, Colorado

5. Liu, Haiping and Muralitharan, Sharmini. A Survey of NY-BR-1

Immunohistochemistry in Breast, Ovarian, Endometrial and Lung

Cancers: A Correlation Study with Estrogen and Progesterone

Receptors. Presented at: San Antonio Breast Cancer Symposium 2009,

Dec 9-13, San Antonio, Texas

6. Haiping Liu, MD, PhD and Sharmini Muralitharan, PhD. A New

Approach to Breast Carcinoma Detection: NYBR-1 Teamed up with

Mammaglobin and Gross Cystic Disease Fluid Protein-15. Presented

at: United States and Canadian Academy of Pathology 2009, March

10th 2009, Boston, MA

7. Haiping Liu, Xiao-Ying Meng, Nisha Patel and Sharmini Muralitharan.

A New Ultra Sensitive Detection System Significantly Improves

Immunohistochemistry Performance With Rabbit Monoclonal Antibodies.

Presented at College of American Pathologist 2010, September 26 -

29, 2010, Chicago, IL

8. Shinobu Heier, PhD, Alexander Rzhevskii, PhD, Sharmini

Muralitharan, PhD, Adam Gobetti, MS, MBA, Erico von Bueren, MD,

PhD, Jennifer Freeland, BS, HTL (ASCP)CM THE IMPACT OF FIXATION &

PROCESSING ON HER2 PROTEIN STRUCTURE & EXPRESSION: COMPARISONS VIA

IHC, IR & RAMAN SPECTROSCOPY. Thermo Fisher Scientific, Division

of Anatomic Pathology, 4481 Campus Drive, Kalamazoo, MI 49008.

Presented at National Society of Histotechnology, Sept. 2010,

San Diego, CA

9. Shinobu Heier, Alexander Rzhevskii, Sharmini Muralitharan, Jennifer

Freeland, Erico von Bueren, Adam Gobetti. Comparing IHC, IR, and

RAMAN Spectroscopy for Classification of Tissue and Cell Lines

Containing Different Level of HER2 Protein Expression. Thermo

Fisher Scientific, Division of Anatomic Pathology, 4481 Campus

Drive, Kalamazoo, MI 49008. Presented at National Society of

Histotechnology, Sept. 2010, San Diego, CA

10. Erico von Bueren, MD PhD MOR1, Nisha Patel, BS1, Kelly McGann-

Tiedt, BS1, Barry Sandbank, PhD1, and Sharmini S. Muralitharan,

PhD1. Development of an Algorithm to Analyze a Peptide Based

Control Slide and Detect Procedural Errors in the Analytical Phase

of the HER2 IHC Staining Process. Thermo Fisher Scientific,

Division of Anatomical Pathology, 46117 Landing Parkway, Fremont,

CA 94538. Presented at National Society of Histotechnology, Sept.

2010, San Diego, CA

11. Haiping Liu MD PhD, Xiaoying Meng MS, Nisha BS and Sharmini

Muralitharan PhD. AN IMPROVED BIOTIN-FREE POLYMER DETECTION SYSTEM

VALIDATED WITH THIRTY COMMONLY USED CLINICAL ANTIBODIES.

Anatomical Pathology Department, Thermo Fisher Scientific, 46117

Landing Parkway, Fremont, CA 94539, USA Presented at the National

Society of Histotechnology, Sept. 2010, San Diego, CA,

12. Erico von Bueren, MD PhD MOR1, Nisha Patel, BS1, Kelly McGann-

Tiedt, BS1, Barry Sandbank, PhD1, and Sharmini S. Muralitharan,

PhD1. Analysis of HER2 Peptide-Based Analyte Control Slides. The

Journal of Histotechnology, December 2010. Vol 33(4): 153-156. NSH

Vendor Poster Award Winner.

Workshops: :

1. Sharmini Muralitharan, PhD., Potential Role of Peptide Analyte

Controls in IHC. California Society for Histotechnology, Workshop # 7,

2009 Symposium/Convention, Millbrae, California.

Reference: Available upon request

Status: US citizen

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