Pharmacokinetic Scientist

V. SRIPHANI GOVARDHANA

*** ********* ********, *** *** Nepean, ON, K2B8G2 707-***-**** ************@*****.**.**

OBJECTIVE

To seek a challenging position as a Pharmacokinetic Scientist in a Pharmaceutical Industry

SUMMARY OF SKILLS

• 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 In progress

M.Pharm (Biopharmaceutics and Pharmacokinetics) – Berhampur University – India 2002

(Graduated with Distinction: University First Rank – Gold Medallist)

B. Pharm – Kakatiya University – India 1999

EMPLOYMENT EXPERIENCE

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.

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