Software Development

SREE HARITHA CHALASANI

** **.******** ******, *** # 8, Boston, MA 02115? (617) 515-

1872?**********.*********@*****.***

SUMMARY OF QUALIFICATIONS

. Strong working knowledge of Formulation Development, Validation and

Scale-Up.

. Excellent knowledge in solid oral dosage form manufacturing processes

such as wet granulation, extrusion spheronization, compression and

coating.

. Effective team player and multi-tasker. Easily adapts to changing

work requirements and environments.

. Broad skill-set in analytical equipment including Liquid

chromatograph - Mass Spectrometer (LC-MS) with Electron Spray

Ionization and Atmospheric pressure chemical ionization, Gas

chromatography (GC), and High Performance Liquid Chromatograph (HPLC)

. Experienced in working with small animals including rats and mice.

PROFESSIONAL EXPERIENCE

Vertex Pharmaceuticals, Cambridge, MA May

2010-present

Sr. Scientific Associate, Formulation Development

Formulation Development

. Developed an immediate release granule formulation by extrusion

spheronization. Worked on Wurster coating to obtain controlled

release formulation from the granules with tunable release profiles.

. Developed a controlled release formulation using high-shear

granulator.

. Performed characterization of key physical properties that influence

downstream processing.

Analytical Development

. Estimated the release profile of the prepared formulations in

different media using USP IV flow-through apparatus.

Center for Drug Discovery, Northeastern University, Boston, MA

January 2009 - May 2010

Research Assistant,

In Vitro-In Vivo Drug Metabolism Studies using CYP450

. Identified metabolites of CYP450, and determined their intrinsic and

hepatic clearance by in vitro metabolism studies. Analysis carried

out by LC-MS.

. Performed in vivo studies in mice: Cassette dosing by oral and

intravenous routes. Clearance of metabolites of CYP450 was

determined.

. Established an in-vitro in-vivo correlation.

Receptor Binding Assays

. Prepared synaptosomal membranes from rat brain. Estimated membrane

protein concentration using Bradford Protein Assay.

. Maintained two HEK 293 (Human Embryonic Kidney) Cell lines

transfected with two Cannabinoid receptors. Isolated cannabinoid

receptors by cell lysis.

. Carried out 96 well plate-based high throughput screening with

radioactive labeled materials.

. Performed assays like Saturation Binding Assay, Competition Binding

Assay and Covalent Binding Assay to screen novel chemical entities

for their potency and selectivity. Analyzed data using GraphPad Prism

software and interpreted results.

. Documented study results, and presented conclusions in biweekly group

meetings.

. Performed functional Assays like GTP?S Assay, cAMP Assay, and MAP

Kinase Assay.

. Trained undergraduate students, graduate students with these

techniques.

Dr.Reddy's Laboratories, Hyderabad, India

January 2008 - June 2008

Project Intern, Product Development

Product and Process Optimization

. Optimized the composition of a tablet formulation using design of

experiments (DOE). Evaluated the influence of each excipient on the

physical properties of the tablets.

. Optimized key process parameters including fluid intake, kneading

speed, drying temperature, percentage loss on drying (LOD), dried

granule size, punch penetration and force, and stress effects on

coating at bench-scale. The granulation end point was detected using

torque sensors.

. Validated and scaled up the tablet formulation to pilot-scale.

Batches with the optimum composition were prepared, validated and

scaled up to pilot-scale.

. Achieved a direct correlation from bench to pilot scale by utilizing

equipment parameters and batch size.

Genix Pharmaceuticals, Hyderabad, India

May 2006 - July 2006

Project Intern

. Learned the basic principles of HPLC and GC.

. Analyzed samples of manufactured drug substance using HPLC and GC.

ACADEMIC EXPERIENCE

Birla Institute of Technology and Science, Pilani

January 2007- December 2007

Undergraduate Student

Controlled Drug Delivery Systems

. Formulated gelatin microcapsules for controlled drug delivery for an

external partner. Risperidone was microencapsulated by precipitating

gelatin on solubilized drug particles.

. Optimized trapping efficiency of the drug by varying excipient

levels.

. Developed in-house UV visible spectrophotometric method to determine

the drug concentrations.

. Evaluated the release profile by dissolution studies over extended

periods of 24 hours.

Quantitative Structure Activity Relationships (QSAR) and Quantitative

Structure Pharmacokinetic Relationship (QSPkR)

. Investigated various descriptors and software used in determining the

QSAR and QSPkR relations.

EDUCATION

Northeastern University, Boston, MA

May 2010

Master of Science in Pharmaceutical Sciences, Specialization:

Pharmaceutics and Drug Delivery Systems.

Birla Institute of Technology and Science, Pilani, India

June 2008

Bachelor of Pharmacy (Hons.), June 2008

Major GPA: 3.85/4.0

Relevant Coursework

Mass Spectrometry, Pharmacokinetics, Biopharmaceutics, Advanced Physical

Pharmacy, Biochemistry, Molecular Cell Biology, Pharmacoeconomics,

Biostatistics.

AWARDS AND HONORS

. Awarded the Gold medal for "BEST B.PHARMACY (Hons.) GRADUATE" at Birla

Institute of

Technology and Science, Pilani, India.

. Received the Merit Scholarship at Birla Institute of Technology and

Science, Pilani, India.

. Recipient of the prestigious Scholarship from the Government of India

for academic excellence.

SOFTWARE EXPERTISE

GraphPad Prism, SPSS software, Umetrics Software, Word, Excel, PowerPoint,

Outlook.

Contact this candidate