Scientist/ Chemist

DEEPTHI KOTA

****B Cambria Drive

Email: *************@*****.***

Greenville, North Carolina 27834

Phone: 919-***-****

Summary

. A self-motivated and goal-oriented professional, seeking a challenging

full-time position in pharmaceutical/ biotech industry

. Experience in analytical techniques and instruments such as HPLC, TLC,

TGA, MSA, DSC, NIR, FTIR, UV-Vis spectrophotometer, Karl Fischer

titrator, and dissolution.

. Experience in designing of experiments, protocol execution, method

transfers, writing reports and wet chemistry techniques.

Work Experience

Chemist-I (Quality Control- Raw Materials)

Sandoz, Inc., Wilson, NC

June 2014-January 2015

Accomplishments: Recognized for Right the First Time, speak up for safety

and as a team-player.

. Performing wet-chemistry testing of raw materials according to USP and

In-house methods

. Documenting the tests performed adhering to good CGMP documentation

practices

. Performing 5S audit and weekly inspection of the laboratory

environment

. Performing HPLC testing for APIs and raw materials and analyzing data

using Empower software

. Using LIMS (Laboratory Information Management System) for entering the

test results, auditing notebooks, logbooks, data compilation and

generation of reports as per the specifications

. Involved in Product and Process Qualifications (PPQs) thereby

supporting finished products testing as needed

. Assisting supervision with investigations on Out of Specification

(OOS), deviations and failure results

Lab Analyst-I (Analytical Development-Chemistry)

DSM Pharmaceuticals, Greenville, NC

July 2013- June 2014

Accomplishments: Recognized as an employee with driving for results and

Right the First Time qualities.

. Successfully performed method transfers (involving HPLC) for the new

projects according to the client requirements

. Performed physical testing (bulk density, tapped density) and particle

size analysis of the samples at different stability time points

according to the SOPs and USP methods

. Accurately documented all the information in laboratory notebooks

according to the CGMP requirements

. Worked with Atlas Software to collect, process the chromatographic

data and generated the reports

. Used LIMS and SLIMS (Stability Laboratory Information Management

System) to track samples and for entry of the results

. Used Trackwise system to create a record of the

instrument(s)/equipment(s) used for testing

. Performed method validation and stability testing, weekly housekeeping

maintenance inspection and monthly reagent inspection

Laboratory Teaching Assistant

Campbell University- College of Pharmacy and Health Sciences, Buies Creek,

NC January 2013- April 2013

. Assisted Pharm-D students in the preparation of various pharmaceutical

dosage forms

. Prepared stock solutions required for the lab sessions

. Performed chemical inventory work at the end of each lab session

Tutor

Campbell University- College of Pharmacy and Health Sciences, Buies Creek,

NC August 2012- April 2013

. Bio-pharmaceutics and Biostatistics- mentored students who required

extra attention to understand the course material by conducting

individual tutoring sessions

Graduate Assistant

Campbell University- College of Pharmacy and Health Sciences, Buies Creek,

NC December 2011- April 2013

. Clinical data entry work for the projects done by my research advisor

. Helped in the editing process of table of contents, index and glossary

parts of the 'Integrated Pharmaceutics-Applied Preformulation, Product

Design and Regulatory Science' text book, written by the Professors of

Pharmaceutical Sciences Department- Campbell University

. Performed chemical inventory work for Pharmaceutics labs at the end of

every semester

Skill set:

. Analytical instrumentation: HPLC, TLC, UV-Vis Spectrophotometer,

DSC, TGA, Moisture Sorption Analyzer

(MSA), Karl Fischer titrator, Malvern Zetasizer, Sonic Sifter, Micron Air

Jet Sieve, FTIR, and NIR.

. Formulation Techniques: preparation and testing of various

pharmaceutical dosage forms such as tablets,

capsules, suspensions, emulsions, ointments and gels and testing

according to USP monographs. Hands-on

experience using Manesty Betapress, Dissolution apparatus, Franz cell

diffusion apparatus, Loss on Drying

(LOD) balance and Fluid Bed Granulator (Mini Glatt).

. Wet-Chemistry: Loss on Drying, Residue on Ignition (ROI), Heavy

Metals and so on.

. Validation: preparation of installation/ operational qualification

(IQ/OQ) protocol, USP method verification, and familiar with

Performance Qualification (PQ) and Performance Maintenance (PM).

. Others: SDS-PAGE, working experience with USP-NF, and EP compendia.

. Documentation: preparation of Master Batch Records, Certificate of

Analysis, Laboratory Worksheets, and

Laboratory Notebook.

. Technical skills: JMP programming (Statistical Software by SAS), Atlas

software (HPLC), Empower, MS-Excel,

MS-Word, MS-PowerPoint and MS-Outlook.

Education

Campbell University, Buies Creek, NC

August 2011- May 2013

Master of Science in Pharmaceutical Sciences

Major: Industrial Pharmacy

Masters Research Project: The Effect of Tannins on Stability of Human

Insulin in the Presence of Proteolytic Enzymes (Duration: August 2012-

April 2013)

. Insulin when administered orally is degraded by the proteolytic

enzymes. Epigallocatechin gallate (EGCG), a natural tannin with anti-

enzymatic properties was used to protect insulin from degradation.

In-vitro studies were conducted by incubating EGCG solution with

insulin for 1 and 7 hours each at 25 oC and 37 oC respectively.

. The amount of insulin remaining was quantified using reversed-

phase HPLC. JMP software was used to test the statistical

significance of the results.

Research Project: The Effect of Moisture on Magnesium Stearate (Vegetable

Grade) and the Compression Profile of Acetaminophen Tablets (Duration:

August 2012- April 2013)

. The acetaminophen tablets with 0.5% magnesium stearate were

prepared and the initial amount of moisture present in the samples

was estimated. The maximum amount of moisture that can be sorbed by

the sample from 0 to 90% R.H was found out and that amount of

moisture was incorporated into the samples.

. Tablets from the normal and moisture sorbed samples were

compressed and analyzed for the statistical significance of ejection

force using JMP software. The characteristics of tablets like weight

variation, tablet breaking force (USP), friability and

disintegration tests were also performed on the compressed tablets.

Lalitha College of Pharmacy, Affiliated to Osmania University.

Bachelor of Science in Pharmaceutical Sciences

Aug 2007- April 2011

Honors

. Recipient of Cum Laude Honor for showing academic excellence

References

Available upon request.

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