Experienced in process development and analytical techniques

SHALINI GADDAM

**** ******* ******, *** ****, CA - 95111

acr3ap@r.postjobfree.com, 919-***-****

SUMMARY

A self-driven, enthusiastic pharmaceutical professional with a strong focus on productivity and problem solving that utilizes my educational background and experience in preformulation, formulation development, analytical techniques/instruments and research.

Experienced in process development of semi solid dosage forms, development of viscosity methods, development and validation of in vitro release testing (IVRT), HPLC method development for assay and stability indicating methods (SIM) for semisolids and handling of analytical instruments like HPLC, Vertical Diffusion Cells, Viscometer, and Microscopy

Proficient in GMP and GLP documentation

EDUCAT I ON

Campbell University, Buies Creek, NC August 2011- May 2013 Masters in Pharmaceutical Sciences (Industrial Pharmacy) GPA: 3.5/4.0 Master’s Research Project: Chemical Kinetics and Moisture Sorption Studies of Sucrose Octaacetate

(SOA)

o Chemical kinetics of SOA at 5 different pHs while varying temperatures was performed to establish if SOA could be formulated as a bitter tasting control for clinical studies. The samples were analyzed using a stability indicating HPLC method and the data was interpreted to obtain a pH-rate profile. From the pH-rate profile, the pH with lowest degradation rate was found where it can be formulated as a clinical viable product. With the help of Q5000 Sorption Analyzer, the moisture sorption profile of SOA was studied.

Relevant Coursework: Drug Development and Pharmaceutical Regulations, Industrial Pharmacy, Advanced Industrial Pharmacy, Advanced Physical Pharmacy,Experimental Design and Biostatistics, Advanced Experimental Design, Biopharmaceutics, Pharmacokinetics, and Fundamentals of Cellular Pharmacology

Jawaharlal Nehru Technological University, Hyderabad (A.P.), India August 2007 - May 2011 Bachelor of Pharmacy GPA: 3.7/4.0

WORK EXPER I ENCE

Formulation Scientist June 2013 - Present

Research and Development

Tergus Pharma LLC, Durham, NC

o Perform preformulation studies and develop bench scale and pilot scale topical formulations

(RLD/GLP/GMP) in compliance with FDA and safety requirements and perform physical characterization using Brookfield Viscometer, pH meter, and microscopy o Design and execute product development and optimization of semi-solid dosage forms (such as lotions, creams, ointments) by applying Quality by Design (QbD) principles to determine Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) o Design of experiments (DoE) using JMP software and Fusion software o Assist in tech transfer from bench scale to large scale manufacturing o Write and review master batch records, product development strategies and reports o Assist in manufacturing (GLP/GMP) activities under supervision o Perform IVRT for different topical formulations using Hanson and PermeGear Vertical Franz Diffusion Cells

o Design of experiments during the development of IVRT methods o Routinely performing validation of the IVRT methods as per ICH guidelines in a cGMP environment o Perform HPLC method development, transfer, and validation of assay methods and stability indicating methods

o Assist in project management via vendor communication, scientific literature search, and client communication

o Write and review study protocols, stability protocols, methods, and reports o QC review of standard operating procedures (SOPs), lab notebooks, and experimental data SHALINI GADDAM

2724 Ferrara Circle, San Jose, CA - 95111

acr3ap@r.postjobfree.com, 919-***-****

Teaching Assistant May 2012 – May 2013

Industrial Pharmacy (IP) and Advanced IP labs

Pharmaceutical Sciences Department

Campbell University, Buies Creek, NC

o Instructed students to understand the principles and procedures in preformulation (pH, pKa, solubility, and micromeritics), formulation and analysis of different dosage forms o Guided students in the application and use of manufacturing equipments like Quadro Comil (milling), V-blender, and homogenizer and analytical instruments like HPLC (blend uniformity and content uniformity), FTIR, dissolution testing (comparison between coated and uncoated tablets), and Franz cell diffusion (effect of type of emulsion on diffusion rates) o Inventory of chemicals and supplies, prepared solutions necessary for the lab

Laboratory Assistant Dec 2012 – May 2013

Analytical and Formulation Labs May 2012 – July 2012 Pharmaceutical Education & Research Center (PERC)

Buies Creek, NC

o Stability indicating HPLC method development and validation for a steroidal drug o Development of content method for acetaminophen

o Performed microbiological testing, conductivity testing, and total organic carbon (TOC) analysis of the USP Purified Water system; obtained and analyzed air quality samples(non-viable particulate counts) in the GMP manufacturing area

Faculty Assistant Dec 2011 –May 2012

Pharmaceutical Sciences Department

Campbell University, Buies Creek, NC

o Literature search on excipients, their use, trade names and percentage range used in different formulations for completion of book titled "Integrated Pharmaceutics" authored by Dr. Antoine Al- Achi, Dr. Mali R. Gupta, and Dr. William C. Stagner

Student Intern May 2011 - July 2011

MSN Laboratories Ltd., Patancheru (A.P.), India

o Trained in the departments of formulation and quality control (QC) o QC testing on finished products (tablets and capsules) with dissolution and UV-visible spectroscopy

Student Intern Oct 2010-Dec 2010

Suzikem Drugs Pvt. Ltd., Cherlapally (A.P.), India o Trained in the manufacturing department on milling, granulation, and capsule filling SK I LL SET

Laboratory Experience:

Formulation Development and Quality Control Testing: Preparation of lab-scale semi solid formulations and testing according to USP monographs

Documentation: Preparation of methods, protocols, reports, master batch records, and SOPs Analytical Instrumentation: HPLC, HPLC Troubleshooting, Franz Cell Diffusion, Viscometer, Hot Stage Microscopy, Dissolution, UV-Vis Spectroscopy, TGA, DSC, Q5000 Sorption Analyzer, and TOC Technical Skills:

Microsoft Tools: Microsoft Office (Word, Excel and PowerPoint) Other Software: JMP (Statistical Software by SAS), Fusion Software, Waters Empower Software, Agilent Chemstation Software, and Shimadzu Class-VP Software WORKSHOP

Attended a two day USP workshop on “Quality Attributes of Drug Products Applied to the Skin” on September 21- 22, 2015 at USP Meetings Center, Rockville, MD

POS TER PRE SENTAT I ON

Presented poster on “Chemical Kinetics of Sucrose Octaacetate” at American Association of Pharmaceutical Scientists Annual Meeting, November 2013 (San Antonio, TX) (Poster ID: W5311)

Presented poster on “Comparison of In Vitro Release Rates Using Different Vertical Diffusion Cell Designs” at American Association of Pharmaceutical Scientists Annual Meeting, November 2014 (San Diego, CA) (Poster ID: M1060)

SHALINI GADDAM

2724 Ferrara Circle, San Jose, CA - 95111

acr3ap@r.postjobfree.com, 919-***-****

Poster to be presented on “Effect of Critical Process Parameters and Critical Material Attributes on In Vitro Release Rates of Drug Substances from Semi-solid Topical Formulations” at American Association of Pharmaceutical Scientists Annual Meeting, October 2015 (Orlando, FL) AWARDS AND PROFE S S I ONAL AF F I L I AT I ONS

Awards:

Scientist with Compliance Award by Tergus Pharma LLC Oct 2013 Affiliations:

Member of American Association of Pharmaceutical Scientists (AAPS) Aug 2011 – Present

Member of Parenteral Drug Association Southeast Chapter (PDA) Nov 2011 – Present REFERENCE S

Available on request

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