Project Data

V. sRIPHANI govardhana

***** ***** *******, [pic] FREMONT, CA, 94582 [pic] 408-***-**** [pic]

************@*****.**.**

OBJECTIVE

Seek a challenging position as a Pharmacokinetic Scientist in a

Pharmaceutical/Bio-tech Industry.

SUMMARY OF SKILLS

. Lipid-based formulation design and evaluation

. In-vitro dissolution studies

. Nanotechnology (Nanoparticles development, characterization)

. Experience in designing and preparation of Clinical Pharmacokinetic

study protocols.

. Proficient in pharmacokinetic analysis.

. Preparation and reviewing of PK study reports.

. Expertise in Bio-analytical methods using HPLC and Validation of HPLC.

. Experience with WINNONLIN Pharmacokinetic software.

. Very good knowledge of Good Manufacturing Practices (GMP), Good

Laboratory Practices (GLP), Good Clinical Practices (GCP), and Health

and Safety procedures (OH&S Act, WHMIS)

. Operation and handling of Instruments such as DISSOLUTION APPARATUS,

HPLC, GC, FTIR, DSC, UV-VISIBLE, and Particle size analyzer for

measuring size, size-distribution, and ZP

. Excellent Oral and Written communication skills

. Computer Skills: Highly proficient in MS Office, Excel, SAS, and Sigma

Plot.

EDUCATION

PhD in Pharmaceutical Sciences - Monash University - Australia

2010 (Intermission)

M.Pharm (Pharmaceutics) - Berhampur University - India

(Graduated with Distinction: University First Rank - Gold Medalist)

2002

B. Pharm - Kakatiya University - India

1999

EMPLOYMENT EXPERIENCE

SENIOR RESEARCH ASSOCIATE

2012- 2013

Genentech Inc, South San Francisco, USA

. Author CSR PK Sections. Author/review protocols, extract PK and ATA

data from PKS and/or Watson, graph data, and perform NCA analysis,

draft reports, marshal reports through QC and scientific review.

. Conduct PK analyses in support of regulatory filings and/or

analyses needed for project molecule development. Analyze data in

response to regulatory questions; support the preparation of

regulatory documents such as PMP and BLAs. Conduct literature

searches in support of position papers, scientific questions

regarding molecule development or regulatory inquiries.

. Represent Clinical Pharmacology on Project Teams

. Liaise between project team and department scientists. Provide team

with support in the areas PK/PD and clinical pharmacology. Present

data at team meetings.

. Prepare Non Clinical Pharmacology and ADME sections of IND Annual

Reports for ITGR and other functional groups. Conduct annual

literature searches to identify publications relevant to the

development of a given molecule. Review and summarize ongoing and

completed internal studies

Pharmacokinetic SCientist

2009- 2010

Biopharma Services Inc, Toronto, Canada

. Performing literature and data evaluation to provide scientific

background for clinical studies design

. Preparing the PK portion of synopses for clinical studies

. Answering the inquiries in process of preparation and reviews study

protocols

. Performing /reviewing pharmacokinetic analysis of concentration-

time data

. Preparing/reviewing the pharmacokinetic section of study reports

. Interact and providing input and feedback to Biostatistics

Department for data analysis

. Reviewing the statistical output to evaluate study results

. Reviewing study reports

. Providing scientific support to other departments and teams in the

areas of pharmacology, pharmaceutics and pharmacokinetics

. Taking part in revision of the Biopharmaceutics Department and the

company SOPs; provides input into departmental practices and

maintains updated the study- and report-related templates

. Maintaining the Biopharmaceutics Department databases; provides the

department and the company with updated scientific literature and

maintains regulatory guidelines updated

Pharmacokinetic Associate SCientist

2008 - 2009

Biovail Contract Research Organization, Toronto, Canada

. Performing pharmacokinetic analysis for Phase I clinical trials

. Preparing PK study designs by extensively performing Literature search

. Performing pharmacokinetic and statistical analysis using Win-Nonlin

for bioequivalence and comparative bioavailability studies

. Executing pharmacokinetic modeling as required

. Reviewing of protocols and study reports for scientific content, data

accuracy and compliance with current regulatory guidelines

. Responsible for acquiring and maintaining knowledge of national and

international guidelines

. Developing, writing, implementing and maintaining standard operating

procedures related to the Scientific Affairs department

. Writing final report sections (PK memo) and comprehensive summary

bioequivalence (CS-BE)

. Interpreting and presenting project related study results and

recommendations to the project teams

TECHNICAL TEAM MEMBER 2006 -

2007

Glaxo Smithkline Inc. Mississauga, Canada

. Involved in Quality Control and Packaging of Finished pharmaceutical

Products

Pharmacokinetic Scientist

2002 - 2006

Pulse Pharmaceuticals Pvt. Ltd., Hyderabad, India

. Involved in the Clinical Pharmacokinetic (PK) studies on human

volunteers.

. Prepared protocols for BE/BA studies.

. Conducted PK studies obtaining various biological fluids such as blood

and urine and analyzed the drug content in the bio samples

employing validated HPLC techniques.

. Compilation of PK data using WinNonlin software

. Evaluation of Pharmacodynamic activity of Diclofenac Sodium, and

Rifampicin Oral formulations after intraperitoneal administration to

mice.

. Validation of the data using appropriate statistical packages,

compilation of the final data, reporting of the data, and giving

preliminary interpretations of the results. [pic][pic][pic][pic][pic]

Contact this candidate