Management Medical

SWATI SHARMA

Apt# ***W, *** MLK Dr W, Phone: 513-***-****(M), 513-***-****(H)

Cincinnati, OH 45220 Email: *****.*****@*****.***

CAREER OBJECTIVE

To join, contribute and grow within the dynamic pharmaceutical / biotechnology / CRO environment. The areas of drug safety, pharmacovigilance, medical scientific liaison, regulatory and medical affaires are in my particular interest.

EDUCATION

Clinical Trials Design and Management Certificate Jan 11’-Present’

University of California at San Diego

Introduction to Pharmacovigilance and Drug safety Certificate May 11’

BiopharmaInstitute

Master of Science in Biotechnology Jul 09’ Northeastern University, Boston, MA

Bachelor of Biotechnology Jun 06’

Bundelkhand University, UP, India

RELATED COURSES AND SPECIFIC SKILLS

Introduction to clinical research: History and Terminology, CRO’s, types of clinical trials designs.

Medical terminology: MedDRA, COSTRAT, WHOART

Human subjects protection and IRB’s: Ethics of clinical trials, types of IRB’s reviews and IRB’s issues.

Drug safety surveillance and reporting: History and terminology, medDRA coding, pre ands post marketing drug safety surveillance, SAE’s, ADRs reporting, ICRF’s.

Regulatory compliance for drugs and biologics: FDA and ICH regulatory reporting requirements for drugs, biologics and medical devices.

Computer skills: Windows XP/NT/2000, Mac OS, Linux, SQL

Technical skills: Good knowledge of ARISg, Strong knowledge of medDRA coding. Strong understanding of drug safety sector modules and framework, firm grasp on pharmacovigilance processes and activities, good knowledge of IB (investigator’s brochure) and E2B(R) Electronic transmission of individual case safety report forms (ICRF): SGML and XML format. Effective time management skills, Microsoft Office (Word, PowerPoint, Excel, Access). Strong understanding of drug development process.

Excellent interpersonal skills

Teamwork as well as leadership approach.

PROFESSIONAL EXPERIENCE & ACHIEVEMENTS

Taligen Therapeutics, Cambridge, MA Nov 09’- Oct 10

Research Associate (In vitro Pharmacology group)

• Actively Contributed in Research and Pre-clinical development team for treating debilitating diseases related to Alternative Complement pathway.

• Developed various In vitro Elisa Assays for Isotyping of relevant antibodies titers in Cynomolgous serum for the immunogenicity studies of the lead compound.

• Screened peptides for determination of immunogenic regions on the lead compound.

• Performed Weislab Assays for investigating inhibition of CAP in serum for the drug.

• Performed Data analysis and presented in company and in various outside company meetings.

Research Associate (Molecular Biology and Process Development group)

• Working on formation and optimization of different constructs for manipulation of our drug molecule in various ways using latest gene synthesis technologies.

• Working thoroughly on NTI vector software for gene building, primer design and sequence alignment.

• Pilot scale and medium scale Protein expression and Purification using AKTA.

• Maintained E293F and CHO cell lines for transfection and passaging purposes.

• Performed Data analysis and presented in company and in various outside company meetings.

• Achievement: The lead compound that I was working on was successfully moved to IND submission and now it is Human Phase -1 Clinical trial for Paroxysmal nocturnal hemoglobinuria (PNH).

Merck, EMD Serono, Billerica, MA Jan 09’-June 09’

Intern (Antibody Technologies)

• Hybridoma preparation (Maintained tumor cell lines: 293-E cells, NS0, TF-1 cells, Tissue Culture), screened Hybridomas and performed cell culture scale-up.

• Developed Chimeric antibodies; Bispecific anti-X mAb: successfully expressed and shown to be better than parental alone.

• Expressed Recombinant DNA in bacterial systems (employed PCR, RT-PCR for r DNA amplification).

• Constructed Plasmid for r DNA expression and analyzed sequence of r DNA (using DNASTAR’S Lazergene software and MB-DNA Analysis software.

• Performed Antibody Binding assays (ELISA, T-cell proliferation assay) and small-scale purification.

Aimil Pharmaceutical Ltd, New Delhi, India Jul 06-Apr 07’

Contract Employee (R&D, Pharmaceuticals)

• Studied Rheumatoid Arthritis etiology.

• Assisted in preparation of chemical formulation and packaging of drug.

RESEARCH EXPERIENCE_________________________

Institute of Genomics & Integrative Biology, Delhi, India Jun 05 - Aug 05’

Research Assistant

• Studied Bacillus subtilis as model organisms to understand the sporulating pathway of Bacillus Anthracis.

• Assisted in Cloning & Characterization of putative/ Response Regulator SpoOA of Bacillus Subtilis.

• Handled Biological specimens like purified proteins and bacterial and mammalian cell culture Supernatants.

Mohan Meakin Limited, Gurgaon, India Jun 04-Jul 04’

Intern (Bioprocess)

• Optimized large scale “fed batch fermentation” for production of Ethanol and consumable

Alcohol Bioreactors design parameters and handling.

ACADEMIC PROJECTS AND PAPER PRESENTATION

• Paper on Recombinant Protein Production in Bacterial and Apr 09’

Mammalian Expression system.

• Project entitled “Detection of small molecules by Gas Chromatography”. Dec-08’

• Project entitled “Production of Agaricus bisporus, Volvarialla volvacea Feb 06 - Apr 06’ And Pleuroteus spp.

MANAGEMENT & DOCUMENTATION SKILLS

• Inventory management.

• Process Order and Invoice management.

• GLP documentation.

• Managed multiple projects at a single time effectively.

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