Formulation scientist/Pharmaceutical

Location:

Memphis, TN

Salary:

60000

Posted:

July 05, 2012

Contact this candidate

Resume:

Curriculum Vitae

Kanwaldeep K Gill

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

****, *********** ****, ***# ***

Monroe, LA-71203

318-***-****

Objective

Enthusiastic graduate research scientist having extensive hands-on skills in distinctive drug development areas encompassing pre-formulation studies, bio-analytical method development, formulation development and biological evaluation of specialized sustained release nano-drug delivery systems, oral dosage forms and parenteral product formulations is looking to lead R&D activities in formulation and process development, novel drug delivery systems and nano-biomedicine in major pharmaceutical firm.

Education

Ph.D. in Pharmaceutics Jan2008 – May 2012

Department of Basic Pharmaceutical Sciences

College of Pharmacy, University of Louisiana at Monroe

Monroe, LA– 71203

B.S. in Pharmaceutical Sciences (B.Pharm) Jul 2002 - Jun 2006

Department of Basic Pharmaceutical Sciences

Guru Nanak Dev University, Amritsar, India-143001

Research Summary

• Strong demonstrated ability in the area of formulation development, characterization and optimization of passively and actively tumor targeted, sustained release nanoparticle based delivery systems particularly, polymeric micelles, pegylated lipids and liposomes for encapsulation of poorly soluble drugs.

• Experience in screening of a broad range of parenteral drug delivery systems to enable the development of poorly soluble and/or unstable compounds.

• Expertise in development of early phase characterization assays for formulation optimization including HPLC, LC-MS, DSC, TGA, NMR, particle size, zeta potential, FTIR, TEM, PXRD, dissolution testing, lyophilzation, UV, fluorescence and cell based assays.

• Proven experience in undertaking exhaustive pharmacological assays such as flow cytometric analysis, western blotting, confocal microscopic imaging and cytotoxicity assays.

• Hands-on experience in conducting intensive invivo studies such as investigating pharmacokinetics, tissue biodistribution, anti-tumor efficacy studies of developed drug product formulations, oral dosage forms and parenteral formulations in cell culture and animal models.

• Proven ability in carrying out extensive invitro and invivo toxicological evaluations (acute and chronic) of inhalable and systemically delivered drug delivery systems in cell culture and animal models.

• Independently developed and validated robust and sensitive LC-MS/MS (API 3000 and 4000) and HPLC (Waters, Shimadzu, Agilent) methods for quantification of active pharmaceutical ingredients and drug product formulations in complex biological matrices including cell lysates and plasma matrices.

• Expertise in using many chromatographic software including Waters Empower 3, Shimadzu's LC Solution and Analyst® LC/MS Software.

• Expertise in various sample preparation techniques like protein precipitation, liquid-liquid extraction and solid liquid extraction in different matrices (cell lysates, plasma and drug product formulations).

• Hands on experience from project planning and operation of analytical instruments to data collection and interpretation

Technical skills and Expertise

Formulation Development, Optimization and Characterization skills

• Formulation development of nanoparticle based delivery systems, Pegylated lipid micelles, solid lipid nanoparticles, polymeric micelles, liposomes, oral dosage forms and parenteral products and controlled release drug delivery systems.

• DSC, TGA, NMR, particle size analysis (DLS), zeta potential, FTIR, TEM, PXRD, dissolution testing, lyophilzation, UV, fluorescence.

• In-vitro dissolution, USP dissolution apparatus, In-vitro diffusion; Franz diffusion.

• Physical and chemical stability studies using HPLC, LCMS and Particle size analysis.

• Well versed with cGMP lab techniques.

• Documentation of laboratory report, validation protocol and SOP.

Bio-Analytical Skills

• Developed and validated sensitive LC-MS/MS (API 3000 and 4000) method to determine the cellular uptake of drugs as well as plasma pharmacokinetic profiles of drugs.

• Developed and validated UV-HPLC (Waters, Shimadzu, and Agilent) methods to determine the encapsulation efficiencies of the drugs in delivery vehicles and bio-analysis of the compounds in cells, plasma and tissues.

• Derivative UV spectroscopy for quantitative analysis of more than one drug in single formulation, TLC.

Cell culture and Microbiology and Skills

• Adept in various biological techniques like mammalian cell culture, multi-parameter flow cytometry, FACS analysis, confocal and fluorescence microscopy; immunologic techniques including ELISA, gel electrophoresis, western blotting & immunofluorescence; multiplexed assays.

• General microbiology and basic cell culture; media preparation; culturing techniques; culture maintenance.

• Proficient in low, medium and high throughput cell-based assays for evaluating efficacies of developed drug product formulations, formulation toxicity, cellular toxicity, invitro cytotoxicity oxidative stress, proliferation & migration, apoptosis, cell uptake.

• Highly skilled in establishing and maintaining primary and immortalized cell lines.

Animal Handling Skills

• Proficient in preparing dose and vehicle formulations and performing animal dosing by various routes of administration (oral, IV, pulmonary, subcutaneous and IP).

• Expert in rodent surgeries like Femoral Vein & Artery Cannulation, Carotid Artery Cannulation, Jugular Vein Cannulation and bronchoalveolar lavage studies.

• Expertise in investigating tissue biodistribution and plasma pharmacokinetic analysis

• Statistical and pharmacokinetic data analysis using kinetic.

Software

• Waters Empower 3 Chromatography data software

• Shimadzu's LC Solution software

• Analyst® LC/MS Software

• MS-Office®, Endnote®, Acrobat® Professional

• GraphPad Prism®, Origin®, Kinetica®, JMP

Experience

Professional Research Experience

Graduate Research Assistant Jan 2008 - Present

Department of Pharmaceutical Sciences,

College of Pharmacy, University of Louisiana at Monroe-71201

Supervisors: Dr.Sami Nazzal, Ph.D.

Dr.Amal Kaddoumi, Ph.D.

Teaching Experience

School of Pharmacy, University of Louisiana at Monroe, LA-71203

Lab supervisor for Drug delivery systems lab Spring 2010 - Fall 2011

Teaching Assistant for Drug delivery systems lab Spring 2008 - Fall 2009

Industry Experience

Suzikem Drugs Private Limited, Hyderabad, India-500 016 Feb 2007- Nov 2007

Job Description:

• Trained in essential aspects of formulation development and characterization of nano and micro sized drug delivery systems.

• Emphasizing on preparation of tablets, capsules, quality control development and good manufacturing practices.

• Complete accurate process documentation in accordance with GMP, to include manufacturing documents and preparation of reports.

• Collate information and interpret data during development work.

Supervisor: Dr. Zubair Siddique, Ph.D.

OVERVIEW OF RESEARCH PROJECTS

Project 1: Evaluate the potential of paclitaxel loaded Pegylated-lipid micelles as pulmonary delivery platform: Formulation development, characterization, plasma pharmacokinetics and toxicological evaluation

Highlights:

Successfully formulated paclitaxel in PEG-lipid micelles which exhibited sustained

release behavior in the simulated lung fluid invitro.

Able to achieve highest accumulation of paclitaxel in the lungs following pulmonary

delivery of micellar paclitaxel in comparison to intratracheally delivered Taxol®

Toxicity studies showed no significant increase in levels of lung injury markers in

micelle treated groups, thus apprehending the safety of micelles as novel drug carriers

for lung.

Project 2: Formulate, characterize and investigate the biological activity of multidrug loaded mixed micelles of PEG (2000)-DSPE and Vitamin E TPGS against lung adenocarcinoma cell lines

Highlights:

Successfully formulated and characterized multidrug loaded mixed micelles with

desirable formulation parameters

Successfully integrated combination chemotherapy and nanomedicine to fabricate the

multidrug loaded micelles that were able to sensitize the Taxol® resistant cell lines

and afford significant cancer cell death.

Physically and chemically stable mixed micelles showed controlled drug release

behavior invitro

Project 3: Formulation development, characterization and biological evaluation of multifunctional epidermal growth factor (EGF) targeted Pegylated micelles for combination chemotherapy against lung cancer

Highlights:

Successful in efficient conjugation of epidermal growth factor (EGF) targeting moiety

on the surface of multidrug loaded mixed micelles.

EGF-targeted micelles showed superior efficacy with significant cytotoxicity against

non small cell lung cancer cell lines

EGF targeted micelles displayed significantly higher cellular uptake which was reflected

even in the confocal laser scanning microscopic studies displaying high fluorescence

intensity inside the cytoplasm.

Mechanistic studies on increased efficacy carried out using western blot analysis and

performing quantitative and qualitative apoptotic analysis.

Project 4: Exploring the P-Glycoprotein (P-gp)-Paclitaxel interaction and plasma pharmacokinetics for micellar paclitaxel using the rapid and sensitive LC-MS method developed for biological samples.

Highlights:

Successfully developed and validated a robust and rapid LC-MS method that ensures fast and accurate quantification of paclitaxel when delivered at low concentrations to tumor cells in culture as well as in plasma when administered invivo for pharmacokinetic studies

Utilizes simple one-step protein precipitation for sample preparation

Demonstrated that encapsulation of paclitaxel in micelles bypasses the P-gp mediated efflux pump which has desirable clinical implications in cancer chemotherapy.

Plasma pharmacokinetic studies showed the proficiency of Pegylated micelles in maintaining high paclitaxel levels in the body for longer time as compared to Taxol

Publications and Abstracts

1. Gill KK, Nazzal S, Kaddoumi A. (2011). Paclitaxel loaded PEG5000-DSPE micelles as pulmonary delivery platform: formulation characterization, tissue distribution, plasma pharmacokinetics, and toxicological evaluation. (European journal of Pharmaceutics and biopharmaceutics, 79 (2): 276-84)

2. Gill KK, Nazzal S, Kaddoumi A. (2011). Mixed Micelles of PEG2000-DSPE and Vitamin E TPGS as Nanoplatforms for Concurrent Delivery of Paclitaxel and Parthenolide: Enhanced Chemosensitization and Antitumor Efficacy against Non Small Cell Lung Cancer (NSCLC) Cell Lines (European journal of Pharmaceutical Sciences, 46(1-2):64-71)

3. Gill KK, Nazzal S, Kaddoumi A. (2012). Exploring the P-glycoprotein-Paclitaxel Interaction and Plasma Pharmacokinetics of Micelle Entrapped Paclitaxel Using Rapid and Sensitive LC-MS Method Developed for Biological Samples (under review by Analytical Biochemistry)

4. Gill KK, Nazzal S, Kaddoumi A. (2012). Epidermal Growth Factor (EGF) Targeted Multidrug Loaded Mixed Micellar Nanocarriers against Multi-drug Resistance in Non Small Cell lung Cancer Cell Lines: Formulation development and biological evaluation (in preparation for Molecular Pharmaceutics)

5. Gill KK, Nazzal S, Kaddoumi A. (2012). Pegylated-Phospholipid Micelles: Screening the carrier Prospects for Cancer Therapy. Review article (under review by Journal of Controlled Drug Release)

Poster Presentations at International conferences

1. Gill KK, Nazzal S, Kaddoumi A Mixed micelles of PEG2000-DSPE and vitamin E TPGS as

nanoplatforms for concurrent delivery of paclitaxel and parthenolide in non small cell lung

cancer cell lines: Formulation Characterization and Biological Evaluation. American Association

of Pharmaceutical Scientists (AAPS) Annual Meeting, October 2011. Washington, DC.

2. Gill KK, Nazzal S, Kaddoumi A. Paclitaxel loaded PEG(5000)-DSPE micelles as pulmonary

delivery platform: formulation characterization, tissue distribution, plasma pharmacokinetics, and toxicological evaluation; American Association of Pharmaceutical Scientists (AAPS) Annual Meeting, November 2010. New Orleans, LA.

3. Gill KK, Nazzal S, Kaddoumi Lung Specific Targeting of Aerosolized Polymeric Micelles

Containing Paclitaxel for treatment of lung cancer Pharm Forum-SRDG Annual meeting 2010

4. Gill, K.K, K.P. Amancha, and A. Hussain. ULM. Pulmonary targeting of aerosolized polymeric

micelles containing paclitaxel for treatment of lung cancer. Pharm Forum-SRDG Annual

meeting 2010

Affiliations and Memberships

• American Association of Pharmaceutical Scientist (AAPS)

• American Association of Cancer research (AACR)

• Southern Regional Discussion Group (SRDG).

• Louisiana Academy Of sciences (LAS)

References:

1) Briski, Karen P., Ph.D.