Management Quality Assurance

SUNITA SHARMA, Ph.D.

***** ******** ******

Apartment # 401

Gaithersburg, MD 20878

Tel.: 301-***-**** (H)

Mobile: 401-***-****

US citizen

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

SUMMARY OF QUALIFICATIONS:

Managerial experience for twelve years.

• Extensive experience in state-of-the-art Quality Systems and Regulatory Affairs including Quality Control and Quality Assurance, Manufacturing (upstream and downstream), Regulatory Compliance, Audit, Training and Validation.

• Substantial knowledge and experience in Product development process, project and program management (evaluate, prioritize and handle) in biopharmaceuticals

• Extensive experience in state-of-the-art techniques in Cell Biology, Protein Biochemistry, Molecular Genetics, Proteomics, Oncology, Microbiology, Virology and Immunology.

• Strong leadership, management and organizational skills.

• Strong technical skills detail oriented, efficient and work well in a team or independently.

• Extensive experience in writing and review of grants, technical reports, SOPs and protocols.

• Excellent communication and interpersonal skills.

• Strong written and verbal communication

• Highly motivated, self starter with broad biological sciences expertise

• Facilitation and presentation skills

• Macintosh and PC proficient

PROFESSIONAL EXPERIENCE:

Biotech and R&D Professional, Scientific/Technical Expert and Leadership Role of Clinical and Commercial Product/device from concept to market

Director, Quality Systems, Regulatory Affairs, Compliance & Sales (Site-Head of US Facility)

Gene Logic, Gaithersburg, MD, Mar. 2011 - Present

Oversight of GLP-compliant Genomics and Molecular Genetics facility, Site-Head of Quality Systems (QA and QC), Regulatory Affairs, Validation, material handling, facility monitoring, customer interactions, Training and Production. Product complaints, Development of Policies, Systems; Strategizing / Organizing projects, Improve efficiency and productivity, Developing /Organizing /Chairing team and management of multiple projects, Keep track of all projects against target, Continuous Improvement, Getting CLIA certification, Implementation of LIMS, Validation of Assays, systems, equipments and processes, Internal and external facility Inspections and QA/QC Audits, Write and Review reports, Management of Documentation, SOPs, Protocols (IRB approved), Continuous Improvement, Training, Management of Deviations, CAPA, Biotracker, Change control, Biorepository, Regulatory activities, FDA, ISO guidelines etc Interaction and management of contractors to assure quality and regulatory compliance, RFI, RFP writing and helping BD sales.

Quality Sr. Specialist (Sr. Manager) – Oversee of cGMP Bulk API and Finished product manufacturing, QA, QC, validation, training, Documentation, facility maintenance, material handling

Amgen, RI, May 2005 – July 2009

Scientific Experience - Area of Cancer research, Virology, Oncology, Genetics, Cellular and molecular aspects of protein and/ or protein related molecules.

Quality Experience – Quality, Safety, Accuracy, Potency and Efficacy of drug, device and/or product.

Quality Management:

• More than 6 years of Quality experience in Federal Regulated Industries with an emphasis on current Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Quality System Regulations (QSR), International Conference on Harmonization (ICH), Human Biologics and Good Tissue Practice (GTP), as well as, ISO9000.

• More than 6 years of CMC (Quality, Development and Regulatory) and Quality Supervisory and Management experience with focused responsibilities for Quality Assurance, Quality Control, Analytical testing, Review for Bioanalytics Laboratories (Biochemistry, Protein Chemistry, Cellimmunology, Microbiology, Raw Materials, Lab Support, Sample Management), Stability and Final Product, Product Process and Program Development, Labeling, Internal/External Audits, Inspections, Document Control, Process Improvement, Regulatory Compliance, Validation, Investigations, Change Control, Training, and Corrective and Preventive action functions. Upstream and Downstream Manufacturing.

Project Management:

• Project Champion for more than 20 years of Project Management expertise with focused responsibilities for evaluation scope, objectives and goals, understand financial and resources planning, coordinate project-level budget and resources, develop and lead cross-functional team, Assess and Manage risks, Plan, schedule, execute and close on time, use of Microsoft Programs (SAP, ePPM, Gantt, PERT, COGNOS), negotiate with team members to resolve issues, Track team performance against objectives, meet or exceed timelines.

• Thorough Knowledge of Product Process Development, Different stages of Product Life-cycle from microscope to market, clinical trials from pre-clinical to clinical III stage and clinical IV stage activities, write, revise or edit SOPs, Protocols and Technical Reports, DOE, ANOVA, Data management and analysis, Create, evaluate, coordinate and develop product plan, strategies and scope, Technology transfer.

General Management:

• Oversee all aspects of Quality Control functions – analytical testing, method development / optimization, technology transfer, qualification, implementation and validation, process validation, laboratory compliance, and risk management.

• Plan, prioritize, organize and responsible for day to day operation of multiple laboratories (Cell Immunology, Biochemistry, Protein Chemistry, Microbiology, Raw Material, Molecular biology and Lab Support) including development and execution of several assays, protocols, standard operating procedures, data presentation / interpretation, supervision of staff.

• Communication and coordination of global and site specific activities within Amgen for continuous improvement and operational excellence of laboratory methods, optimization of laboratory processes/systems. Interaction with Executives / Directors, collaboration within Amgen to share best practices and bring forth consistency in the QC laboratories that support commercial drug substance and drug product supply.

• GMP, GLP, GTP, GCP and ISO guidelines,

• In-process, stability, Release material testing and review, and Disposition

• Internal/External Audit

• Regulatory activities for lot release

• Regulatory filing (IND, NDA, BLA)

• Compliance, Risk assessment and management

• FDA and EU Guidelines, ICH

• Writing and review of technical reports, protocols, Standard Operating Procedures, medical briefings, articles

• US Pharmacopeia (USP) guidelines for product quality and performance test and water, European Pharmacopeia (EP)

• Regulatory liaison with FDA

• Statistical Analysis of Data (ANOVA)

• Investigation, and Product Quality / Safety Program

• Enterprise Document Management System (EDMS)

• Laboratory Information Management System (LIMS)

• Learning Management System (LMS)

• Fast Start in Project Management (FSIPM)

• Operational Excellence

• MAXIMO

• Corrective And Preventive Action Program

• Global Project Portfolio Management (ePPM), PERT, GANTT

• Vendors/customer negotiation

• Design Of Experiments (DOE)

• COGNOS

• Change control Management System (CCMS)

• Validation Program

• Automation of ELISA (Tecan)

• Manufacturing process from inoculum to production to purification

• Sample Management / Sample Repository

Senior Biologist, Oct. 2001 – May, 2005, GS-12/Step 6

National Institute of Health, National Cancer Institute, Bethesda, MD 20892.

Experimental Transplantation & Immunology

Supervised / guided graduate students, associates, summer students and technicians

Reviewed /wrote grants and manuscripts

Kept abreast with update literature and technologies

Attended and presented data in conferences, meetings, seminars and symposium

Principal Accomplishments:

• Zebrafish model of childhood leukemia and ewing Sarcoma

• Using all advanced techniques in molecular genetics, cell biology, immunohistochemistry, RNA In-situ hybridization, microarray etc.

• Mutagenesis in order to identify the additional genetic mutations

• Review / write manuscripts, analyze, prepare and present data in meetings, conferences.

• Supervision of associates, technicians and summer students

Senior Scientist, July 1999 – July 2001

GlaxoSmithKline Beecham Pharmaceuticals, King of Prussia, PA 19406.

Department of Immunology - Drug Discovery

Served As Lab manager

Supervised / guided graduate students, associates, summer students and technicians

Reviewed /wrote grants and manuscripts

Kept abreast with update literature and technologies

Attended and presented data in conferences, meetings, seminars and symposium

Principal Accomplishments:

• Evaluation and Characterization of TRAIL (TNF family Related Apoptosis Inducing Ligand) / Receptors as therapeutic agent for anti-cancer drug (cancer therapy). (JBC, 2000, FASEB J., 2000)

• Role of TRAIL in Rheumatoid Arthritis Vs Osteo-arthritis

• Performed cDNA microarray analysis (Clontech) to check the differential regulation of genes in Rheumatoid Vs Osteo-arthritis patients’ samples.

• Development of functional bioassay kit (ELISA) for measurement of human TRAIL in biological sups

• Reviewed / wrote manuscripts for standard journals, protocols for FDA approval

• Supervised staff performance, laboratory work and technical/ scientific reports

Senior Post-doctoral Associate, 1995-1998

Department of Biochemistry and Molecular Biology, Thomas Jefferson University, Philadelphia, PA 19107

Supervised / guided graduate students, associates, summer students and technicians

Reviewed /wrote grants and manuscripts

Kept abreast with update literature and technologies

Attended and presented data in conferences, meetings, seminars and symposium

Principal Accomplishments:

• Demonstrated the cell cycle inhibition by blocking the cells at G1 phase by HIV - 1Tat protein.

• Established the inappropriate expression and activation of cyclin E and Cdk2 kinase complex.

• Determined the accumulation and inactivation of the tumor suppressor protein, Rb.

• Characterized the activation of HIV - 1 Transcription by Rb through the NF-kB enhancer sequence.

• Investigated the significance of Rb phosphorylation in modulating the HIV - 1 LTR activation.

• Explored the HIV - 1 LTR activity during the G1 phase.

(JBC, 1999)

Senior Post Doctoral Fellow, 1992 - 1995

Fels Institute for Cancer Research and Molecular Biology, Temple University, Philadelphia, PA

Supervised / guided graduate students, associates, summer students and technicians

Reviewed /wrote grants and manuscripts

Kept abreast with update literature and technologies

Attended and presented data in conferences, meetings, seminars and symposium

Principal Accomplishments:

• Explored the mechanism associated with V-src mediated transformation of myeloid cells (32Dcl3).

• Constructed the chimeras between v-src and v-fgr oncogenes (protein tyrosine kinases).

• Demonstrated the effect of src/fgr chimeras on IL-3 dependence of 32Dcl3 cells.

• Characterized the activation of STATs by v-src, v-fgr and src/fgr chimeras.

• Analysed the tyrosyl phosphorylation of STAT proteins by v-src and src/fgr chimeras.

• Examined the translocation of STAT proteins to the nucleus.

• Established the inactivation of JAK kinases by v-src and src/fgr chimeras.

• Demonstrated the co-immunoprecipitation of STAT proteins with v-src antibodies.

(MCB, 1997)

"ROCKEFELLER FOUNDATION" Post Doctoral Fellow, 1989 - 1992

Department of OB-GYN, University of Pennsylvania Medical Center, Philadelphia, PA

Supervised technicians and summer students

Kept abreast with literature and advanced technologies

Reviewed and wrote grants and manuscripts

Attended and presented data in conferences, meetings, seminars and symposium

Principal Accomplishments:

• Established the Proacrosin being synthesised principally by round spermatids and detected in early and late spermatids.

• Characterized the maturation of Proacrosin from higher molecular weight to lower molecular weight form after posttranslational modifications.

• Examined the structural changes in the Proacrosin protein of cauda epididymis from Acrosin of testicular form.

• Demonstrated the greater molecular weight of Proacrosin in spermatids than in cauda epididymis.

• Determined the proacrosin being modified in corpus region of the epididymis.

• Demonstrated the molecular weight conversion during epididymal maturation.

(MRD, 1991: MRD, 1991)

Side Projects: Development of biological assays to characterize the antispermatozoal antibodies

HONORS AND AWARDS:

• Rockefeller Foundation Post Doctoral Fellowship Grant (Univ. of Pennsylvania, PA).

• Research Scientist (Fellowship from Indian Council of Medical Research, India).

• Research Officer (Fellowship from Indian Council of Medical Research, India)

• Merit Fellowship from "Indian Council of Medical Research" during Doctoral degree.

• National Merit Scholarship during Undergraduate and post-graduate.

• National Workshop on "Use of Visual Techniques in Teaching Biology", University Grants Commission.

TEACHING AND COMMUNICATION SKILLS:

• Instructor/ Faculty: Taught Biology I & II (Human Anatomy, Physiology, Biology) in Community College of Philadelphia, PA 1990 - 1992.

• Conducted lectures in Biochemistry, Molecular Biology and Cell Biology.

• Experience in successful grant writing.

• Several years of experience in guiding graduate students and technicians.

• Computer literate: Microsoft Excel, Software Program, data base, word perfect, power point

• Extensive scientific presentations as invited speaker in several International Conferences.

EDUCATION:

Ph.D. (Molecular Biology & Biochemistry), King George's Medical College, Lucknow, India, 1990

Title of the Ph.D. Thesis: "Effect of Drugs and Steroid Hormones (Progesterone, Testosterone, and Estrogen) on the mammalian testes"

M.S. (Molecular Biology & Biochemistry), University of Lucknow, India

B.S. (Molecular Biology, Biochemistry & Chemistry), University of Lucknow, India

Major Sources of Study: Recombinant DNA technology, Molecular Biology of the gene, Molecular Cell Biology, Biochemistry, Molecular Genetics and Developmental Biology, Inorganic, Organic and Physical Chemistry.

TECHNICAL EXPERTISE:

• RNA Isolation, Northern, DNA Isolation and Southern blotting

• DNA Sequencing, RT-PCR, Site-directed mutagenesis.

• Construction and Screening of cDNA and Genomic libraries

• Cloning and subcloning, Genomic Restriction Mapping

• CAT Assays, Gel Shift Mobility Assay

• Preparation of retroviral vectors, Virus titration

• FACScan, Analysis by CellQuest.

• Human and mouse cDNA microarray.

• Peripheral Blood Mononuclear cell isolation

• In vitro Transcription and Translation assays, Kinase assay, Cell cycle Analysis

• Cell Isolation, Tissue Culture, Transfection and Transformation

• Protein Purification and Characterization

• Antibody production and purification

• HPLC, LC/MS, Column Chromatography, and Affinity Chromatography

• 1D, 2D-Gel Electrophoresis, Western blotting, and Immunoprecipitation

• Differential and Density Gradient Centrifugation

• Spectrophotometry, ELISA, RIA, and Enzyme Kinetics

• Electron and Fluorescent Microscopy, Immunohistochemistry

• Microinjections to the animals, embryos

• Proteomics (protein-protein interaction)

• Genetics

COMPUTER EXPERT:

Microsoft excels, Microsoft word, Power point graphics, Outlook proficient and software programs for Macintosh and PC.

Courses taken in Microarrays, Proteomics, GCG, EMBL etc.

GRANTS AWARDED

(Rockefeller Foundation Grant):

Principal Investigator: Sunita Sharma, for two years, $100,000 annual

Maturation of Guinea Pig Sperm in the Epididymis involves the modification of Proacrosin Oligosaccharide side chains

Senior Fellowship from Indian Council of Medical Research, New Delhi, India

Principal Investigator: Sunita Sharma, for two years, Rs. 500,000 annual

Junior Fellowship from Indian Council of Medical Research, New Delhi, India

Principal Investigator: Sunita Sharma, for two years, Rs. 400,000 annual

Fundamentals: Core Curriculum, Orientation to NIH Extramural Activities.

PUBLICATIONS:

1. Targeted proteasome inhibition by velcade induces apoptosis in human mesothelioma and breast cancer cell lines. Wang Y, Rishi AK, Puliyappadamba VT, Sharma S, Yang H, Tarca A, Ping Dou Q, Lonardo F, Ruckdeschel JC, Pass HI, Wali A.Cancer Chemother Pharmacol. 2009 Dec. 4

2. A Phase II trial of Tetrathiomolybdate [TM] after cytoreductive surgery for malignant pleural mesothelioma (MPM). H. I. Pass, G. Brewer, T. Stevens, S. Sharma, D. Smith, A. Wali, S. Merajver; Journal of Clinical Oncology, Vol 22, No 14S, 7051, 2004

3. Wali, A, J Mussman, J Sluchak-Carlsen, S Sharma, S Draghici, R, Reeves, M Bocchetta, M Carbone and HI. Pass. Differential expression profile of methylated genes in simian virus 40 transformed mesothelial cells. Proceedings of American Association for Cancer Research, 43: 5532, 2002.

4. Truneh, A., S. Sharma, C. Silverman, S. Khandekar, M. P. Reddy, K. Deen, M. M. Mclaughlin, G. P. Livi, W. V. Williams, L. Marshall and M. Doyle: Temperature Sensitive Diefferential Affinity of TRAIL for its Receptors: DR5 is the highest affinity receptor. Journal of Biological Chemsirty, 275 (30-233**-*****, 2000.

5. Williams, W. V.,, U Prabhakar, T., T. Fullerton, S. Sharma, E. Erikis, A. Sharma, J. C. Lee, S. Boike, H. M. Davis, A. Truneh and D. K. Jorasky: p38 MAP Kinase inhibitor in Rheumatoid synovium and exvivo: Effects on cytokine production. The FASEB Journal, 14(6), Apr. 20: A1211, 2000.

6. Sharma, S., M. Kundu, A. DeLuca, A. Giordano, J. Rappaport, K. Khalili, and S. Amini: HIV-1 Tat elongates the G1 phase and indirectly promotes HIV-1 gene expression in cells of glial origin. Journal of Biological Chemistry 273 (14): 8130-8136, 1998.

7. Chaturvedi, P., S. Sharma., and E.P, Reddy. : Abrogation of IL-3 dependence of myeloid cells by v-src oncogene requires SH2 and SH3 domains which specify activation of STATs. Mol. Cell Biol. 17: 3295-3304, 1997.

8. Anakwe, O. O., S. Sharma, D. M. hardy and G. L. Gerton: Guinea Pig Proacrosin is synthesized principally by round spermatids and contains O-linked as well as N- linked oligosaccharide side chains. Molecular Reproduction and Development, 29: 172-179, 1991.

9. Anakwe, O. O., S. Sharma, H. Hoff, D. M. Hardy and G. L. Gerton: Maturation of Guinea Pig Sperm in the Epididymis involves the modification of Proacrosin Oligosaccharide side chains. Molecular Reproduction and Development, 29: 294-301, 1991.

10. Sharma, S., A. C. Das and A. Halim: Variations in Human Y-Sperm Count: A Study on Quinacrine Dihydrochloride at different pH and duration. J. Anat. Sci., 5: 15-19, 1986.

11. Sharma, S.: Population Control or Productivity Control, in the news paper " National Herald", 1988, Lucknow, India.

12. Sharma, S. and A. Halim: Cytotoxic Agents Induced Infertility in Male rats. VI World Congress on Human Reproduction, Tokyo, Japan, Oct. 1987.

13. Sharma, S. and A. Halim: Gossypol Induced Infertility in Male rats. X Annual Conference of Environmental Mutagen Society of India, Bhabha Atomic Research Center, Bombay, India, Feb. 1987.

14. Sharma, S., S. Siddiqui and A. Halim: Prenatal Sex-Diagnosis of Male Fetus by Blood Smears. VII International Congress of Endocrinology, Quebec, Canada, Jul. 1987.

15. Sharma, S. and A. Halim: Enzyme Linked Immunosorbent Assay (ELISA) for Detection of Antispermatozoal Antibodies. XV International Congress of Genetics, Ashoka Hotel, New Delhi, India, Dec. 1986.

16. Sharma, S. and A. Halim: Effect of Oestrogen on the Semen analysis in rabbits. 52nd Annual Conference of Society of Biol. Chemists, National Chemical Laboratory, Pune, India, Nov. 1986.

17. Sharma, S. and A. Halim: Effect of Progesterone on the Semen Analysis in Rabbits. VI Annual Conference of Anatomical Society of India, B. R. D. Medical College, Gorakhpur, India, Oct. 1986.

18. Sharma, S.: Fluorescence Microscopy, National Conference of Neurological Society of India, Interdisciplinary Brain Research Center, J. N. Medical College, Aligarh, India, Feb. 1986.

REFERENCES CAN BE PROVIDED UPON REQUEST!

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