Ashish Kalra

419-***-****

acd69n@r.postjobfree.com

SUMMARY

A highly talented and detail-oriented Chemist with proven expertise in formulation and analysis of pharmaceutical drug

products. Extensive hands on experience with HPLC method development, stability analysis, wet chemistry and other

bench analytical activities at research pharmaceutical companies. Comprehensive research experience in the field of

lipid based drug delivery.

EMPLOYMENT HISTORY

January 2013 – Current: Chemist Mason, OH

Procter & Gamble, Mason Business Center

(Contractor for Advanced Testing Laboratory)

Responsibilities:

Testing stability samples by following the testing calendar, protocols and specified methods to produce

accurate results on time

Conducting analytical research and developing/validating methods to test commercial P&G products to

established specification

Performing analytical testing of R&D batches, stability batches, cleaning validation samples and generating

final analysis report

Method transfers and crossovers to P&G laboratories in Canada, Brazil and Mexico

Performing laboratory investigations for any Out-of-Trend or Out-of-Specification Results as per SOP’s to

ensure the root cause is identified and remedial action is taken

Bioequivalence studies for tablets

Documenting all stability work as per SOP’s and GLP

W riting protocols for method validation

International and internal training

Peer reviewing notebooks for GLP compliance

May 2009 – January 2010: Assistant Manufacturing Chemist Bhiwadi, India

Medicamen Biotech Limited

Responsibilities:

Supervision of formulation and quality control of tablet/capsules for Non-Beta Lactam Antibiotics

Supervision of granulation processes including Melt Extruder and Fluid Bed Dryer

Supervision and quality control of Spheronization/Encapsulation/Banding for capsule production

Preparation of laboratory batches

Tablet Dissolution, Disintegration, Hardness and Friability testing

Established specifications for new and/or reformulated products

Participated in team activities to facilitate on-going production improvements

Performed scale up for transition to manufacturing

Understanding and implementing GMPs

August 2010 – December 2012: Graduate Teaching Assistant Toledo, OH

University of Toledo

Responsibilities:

Conducting Pharmaceutics Laboratory for BS in Pharmaceutical Sciences and Doctor of Pharmacy which

involved Formulation of various pharmaceutical dosage forms like suspensions, emulsions, elixirs capsules,

suppositories, eye drops, nasal sprays, etc.

EDUCATION / QUALIFICATIONS

Master of Science in Pharmaceutical Sciences (Pharmaceutics and Drug Design)

University of Toledo Toledo, OH

Graduated: May 2013

GPA: 3.88

Bachelor of Pharmacy

Rajasthan University of Health Sciences Jaipur, India

Graduated: March 2009

GPA: 3.86 (WES Evaluated)

GRADUATE RESEARCH PROJECT

Preparation and Evaluation of Oil-in-Water Self-Nanoemulsifying Systems (SNEDDS) with Potential

for Pulmonary Delivery

Formulation development and screening of oil-in-water nanoemulsions using evaluation of self-emulsification

time, phase diagram domains, and characteristics of resultant nanoemulsions.

Characterization of the formulation containing Cremophor RH 40, PEG 400 and Labrafil M 2125 CS (long

chain triglyceride) using HPLC, UV-Vis, DLS/ZLS, DSC, TEM, FTIR

Nebulization of SNEDDS and Characterization of the mist

Characterization of Mist using TEM and Light Scattering

In vitro studies of carbamazepine and protein loaded SNEDDS

Sterility testing using Staphylococcus aureus

Toxicity testing on NIH 3T3 cell lines using MTT assay

Histological analysis of porcine lung tissue to study local drug entrapment

Permeability studies in zebra fish eggs and HeLa cells

SKILLS

Analytical skills: Proficient in using HPLC, XRF, GC, UV-Vis, DLS/ZLS, TEM, SEM, DSC, FTIR, colorimeter,

coulter counter, microplate fluorometer, auto titrator, Karl Fischer Titrator.

Extensive knowledge of and experience in tablet dissolution, disintegration, hardness and friability test ing

Biological/Cellular biology skills: Cell cultures, cell toxicity studies, MTT assay, tissue permeability studies,

Franz diffusion cells, sterility testing, histological assay, SDS-PAGE

Computer skills: Microsoft office, Chromeleon, Empower, R software for statistical analysis, Sigma plot, Adobe

Photoshop, EndNote, Electronic Lab Notebooking (ELN)

PATENTS AND PUBLICATIONS

US PATENT AND TRADEMARK OFFICE: Provisional patent application 1-54869 “Nanoemulsions, Methods of

Making and Methods of Using the Same” FILED: March 2013

1. Nesamony, J., Kalra, A., Majrad, M. S., Boddu, S. H. S., Jung, R., Williams, F. E., . . Kalinoski, A. L. (2013).

Development and Characterization of Nanostructured Mists with Potential for Actively Targeting Poorly Water -

Soluble Compounds into the Lungs. Pharmaceutical research, 1-15. May 2013

http://link.springer.com/article/10.1007%2Fs11095 -013-1088-2

2. Nesamony, J., Shah, I.S., Kalra, A., Jung, R. (2013). Development, physico-chemical characterization, and in

vitro evaluation of nanostructured oil-in-water mists for pulmonary delivery of poorly water-soluble drugs. Drug

Development and Industrial Pharmacy. July 2013

http://informahealthcare.com/doi/abs/10.3109/03639045.2013.814065

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