Shivangi Naik

** * ********** ** #****, Storrs, CT-06269 USA

Cell: 480-***-**** Email: acoost@r.postjobfree.com

Summary

Scientist with experience in formulation and process development of solid dosage forms. Has experience in

enhance formulation strategies for poorly water soluble drugs. Has also worked on process development and

formulation of peptides using lyophilization.

EDUCATION

Ph. D Pharmaceutics, University of Connecticut at Storrs, CT, USA. Aug 2009 – Dec 2014

Thesis: Process development of solid dosage forms: Micronization and

Electrostatic charging.

M. Pharm., Institute of Chemical Technology (I.C.T – formerly UDCT), Mumbai, India. May 2007 – Aug 2009

First Class - Passed with distinction

Thesis: Formulation and process development of solid lipid nanoparticles for

Topical gels.

B Pharm., Mumbai Educational Trust (MET), Mumbai University, Mumbai, India. Aug 2003 – May 2007

First Class -Passed with distinction.

WORK EXPERIENCE

Research Associate, Department of Pharmaceutical Sciences, UCONN/Pfizer, USA. Jan 2010 – Dec 2014

Funded Research Project: Pfizer, Groton, CT

Developed experimental protocol to quantify specific charge of pharmaceutical powders in a V-blender and

Hopper-chute system in humidity controlled glove box.

Determined electrical properties of small molecules such as work function using MOPAC 2012, a semi-

empirical quantum chemistry package.

Developed discrete element method (DEM) code for frictional electrification of pharmaceutical powders by

incorporating contact mechanics and electrostatic forces.

Developed a robust multivariate model to predict specific charge for ten pharmaceutical powders.

Provided updates to Pfizer through monthly teleconferences and written project reports.

CPPR-NSF Fellowship (Centre for Pharmaceutical Processing and Research)

Developed experimental protocol to study creep and strain rate effects during micronization of

pharmaceutical powders.

Determined breakage stress for pharmaceutical powders using Dynamic Mechanical Analyzer (DMA).

Performed a factorial study to evaluate the effect of feed rate, impeller speed and blade tolerance on

micronization.

Developed DEM code for micronization in impact mills.

Head Teaching Assistant, Department of Pharmaceutical Sciences, UCONN, USA. Jan 2013 – May-2013

• Supervised and coordinated all TA activities.

• Extemporaneously prepared sterile and non-sterile dosage forms including sterile protein formulation, ophthalmic

solution, IV admixtures and nasal solution.

• Conducted laboratory discussions with students and managed laboratory inventory and supplies

Research Intern, Eisai Pharmaceutical, Durham, NC, USA. May 2012– Aug 2012

Worked on freeze drying of proteins.

• Determined heat transfer coefficient for crystal zenith (CZ) and glass vials.

• Performed protein formulation studies with different sugars and designed lyophilization cycle.

• Determined relative stability of peptide formulation to oxidation in glass and CZ vials.

• Performed accelerated stability studies for peptide formulation.

• Assessed the durability of glass versus CZ vials for crystallizable bulking agents like mannitol.

Teaching Assistant, Department of Pharmaceutical Sciences, UCONN, USA. Aug 2009 – Jan 2011

• Prepared sterile dosage forms including ophthalmic and intravenous parenteral.

• Prepared solid dosage forms including tablets, capsules, suppositories, medicated elixir, artificial saliva, liniment,

lotions and cream.

COMPUTER SKILLS

Microsoft Office, Tecplot, Matlab, Minitab, ANOVA, Linux, C.

LABORATORY & INSTRUMENTATION SKILLS

• Experience in formulation of oral solid dosage forms including capsules and tablets.

• Experience in formulation of dosage forms including syrups, lotions, creams, gels, elixirs, emulsions and suspensions.

• Fluent with process operations and equipment including Hammer Mill, high shear wet granulator and pan coater.

• Fluent in dynamic mechanical analyzer (2980 DMA V1.4O), surface area analyzer (NOVE 1000 Surface Area

Analyzer), Malvern Mastersizer 2000E, TGA (TA Q500), surface energy analyzer (SEA Surface Measurement Systems

Ltd., Middlesex, UK).

Fluent in enhanced formulation methods such as solid-lipid nano-carriers (SLN) and nano-lipid carriers (NLC).

Experience in HPLC-UV methods and stability indicating assays.

• Proficient in DSC, UV-VIS, and FT-IR.

• Proficient in sterilization procedures and aseptic filling.

AWARDS & HONORS

Doctoral Dissertation Fellowship. (2014)

Best Poster in Particle Technology Forum, AIChE (2014) “Investigating the effect of material and machine

properties on the triboelectrification of pharmaceutical powders, in USA.

AAPS graduate student research award in Manufacturing Science engineering. (2014)

Best Poster in Particle Technology Forum, AIChE (2013) “ Experimental and Multi-Scale Modeling to

Understand Electrostatic Behavior of pharmaceutical powders, in USA .

Karl Herzog Award (2012) in USA.

Best poster award (2009), CRS “Nanostructured lipid carriers for Tacrolimus”, India

All India rank: 190; percentile: 98.95, GATE for Pharmaceutical Sciences, India

University Grants Commission-Junior Research Fellowship (UGC-JRF) for 2007, 2008, India.

Ratan Tata Scholarship in academic year 2006, 2007, India.

PUBLICATIONS, POSTERS & PRESENTATIONS

1. S. Naik, R. Malla, M. Shaw, B. Chaudhuri. Investigation of comminution in a Wiley Mill: Experiments and DEM

Simulations, Powder Technology (2013) Volume 237, March 2013, Pages 338–354.

2. S. Naik, B. Chaudhuri. Quantifying dry milling in pharmaceutical processing: A review on experimental and modeling

approaches, Journal of Pharmaceutical Sciences, (Manuscript under review).

3. S. Naik, S. Sarkar, B. Hancock, Y. Abramov, W. Yu, B. Chaudhuri. A combined experimental and numerical approach to

explore tribocharging of pharmaceutical excipients in a hopper chute assembly, International Journal of

Pharmaceutical Sciences, (Submitted manuscript).

4. S. Naik, S. Sarkar, B. Hancock, Y. Abramov, W. Yu, B. Chaudhuri. Quantification of tribocharging

of pharmaceutical powders in V-blenders: Experiments, Multi-scale Modeling and Simulations, Pharmaceutical

Research, (Submitted manuscript).

5. E. Sahni, S. Naik, B. Chaudhuri. Numerical Simulations of Unit Operation in Pharmaceutical manufacturing. Wiley Inc.

(Submitted Book Chapter)

6. S. Naik, Vipul Gupta, Saurabh Sarkar, Bruno C. Hancock, Yuriy Abramov, Weili Yu and Bodhisattwa Chaudhuri.

Experimental and Multi-Scale Modeling to Understand Electrostatic Behavior of Pharmaceutical powders: Talk at

AIChE Annual Meeting, Nov’2013 San Francisco USA.

7. S.Naik, Bodhisattwa Chaudhuri. Numerical Modeling, Optimization and Scale-up of Pharmaceutical Milling in a

Hammer Mill, Poster presentation AAPS, Oct 2011, Washington USA.

8. S.Naik, Bodhisattwa Chaudhuri. Investigating Granular Milling in a Hammer Mill: Experiments and Simulation: Talk at

AIChE Annual meeting, Oct 2011, Minnesota Convention Center, and Salt Lake City, Minnesota USA.

9. V. George, S. Sadanandan, D. Ghosh, S. Naik, B. Chaudhuri. Protein Scoring and Assay based kinetic predictability of

fuel biomass or fiber hydrolysis, World Congress on Industrial Biotechnology and Bioprocessing, Washington, DC, June

27-30, 2010.

ACADEMIC COURSES

1. Complex Equilibrium

Study of the physico-chemical and mathematical treatment in pharmaceutical systems. Topics center on

thermodynamics, activity coefficients, acids and bases, solubility, complexation solubilization and protein binding.

2. Kinetics and Mechanisms of Drug Degradation and Stability

Concepts in physical organic chemistry relevant to stability of pharmaceutical drugs and proteins.

3. Fracture Mechanics

Linear elastic fracture mechanics, elastic plastic fracture mechanics, computational fracture mechanics, fracture

mechanisms in metals and non-metals, fracture testing, dynamic and time-dependent fracture, fatigue crack growth,

interfacial fracture, fracture in advanced materials, and engineering applications.

4. Transport Processes

Emphasis on the application of the laws of diffusion to dissolution, membrane transport and release of drugs from

dosage forms.

5. Advanced Biopharmaceutics

Physico-chemical, biopharmaceutical, and physiologic factors controlling the delivery of drug and their sites of

action.

6. Transfer Operations I

An advanced study of momentum, heat and mass transfer with application to complex problems. Cartesian tensors,

non-Newtonian flow, statistical theory of turbulence. Mass transfer in multi-component systems and with chemical

reaction. Mass transfer in drops and bubbles; two-phase flow and fluidization.

7. Introduction to Applied Statistics

One sample, two sample and k-sample problems, regression, elementary factorial and repeated measures designs,

covariance. Use of computer packages, e.g., SAS and MINITAB.

8. Special Topics in Pharmaceutics

Solid Dosage Manufacturing

PROFESSIONAL SOCIETIES

American Association of Pharmaceutical Scientist, AAPS.

Controlled Release Society, CRS.

American Institute of Chemical Engineers, AIChE.

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