**** ****** **** ***, ***********, NC-27560.
4.5 years of experience in pharmaceutical and biopharmaceutical industries.
Professional experience working with sterile injectables, inhalation products, solid dosage forms and ophthalmic products both in an R&D and a regulated QC setup.
Experience in pre-formulation, analytical method development, validation and QC testing.
Experience with raw materials and finished products testing for both small and large molecules.
Proficiency in analytical techniques such as HPLC, GPC, IEC (dionex), GC, FTIR, DSC, TGA, GVS, FTIR, Hot Stage Microscopy, particle size analysis, Karl Fischer, TOC analysis and wet chemistry techniques.
Bio-analytical testing experience along with familiarity with aseptic techniques.
Experience developing methods and generating data for pre-IND and IND candidates
Technical writing skills include drafting protocols, SOPs and validation reports.
Team player with supervisory experience and experience communicating with clients with good communication skills.
Liquidia Technologies, Scientist Oct 2012 - present
Perform analytical method development and validation using HPLC, GPC, GC and Ion Exchange Chromatography as per ICH and USP guidelines for new drugs and drug products.
Perform routine testing of raw materials and finished products using HPLC, IEC, GC, GPC, dissolution testing, Karl Fischer titrimetry, FTIR, DSC, GVS, Turbidimetry, TGA, microscopy, Malvern zetasizer, Osmometry and other wet chemistry techniques as per cGMP and GLP practices.
Perform pre-formulation studies to identify lead candidates and assist in formulation development for early stage formulations
Generate data for pre-IND candidates and provide necessary data for IND filing.
Draft and implement analytical method qualification, validation and transfer protocols as per ICH regulations.
Draft SOPs, qualification and validation protocols, perform lab investigations and analyze OOS and OOT results.
Perform bio analytical testing of vaccines and protein formulations.
Develop cleaning validation protocols for GMP manufacturing equipment
Experience testing inhalation products, sterile injectables and ocular drug products.
Train direct reports and peers on scientific techniques, instrumentation and methods.
Communicate with clients and coordinate with other departments within the company to meet project deadlines.
Formulation and QC Associate, Aug 2012 – Oct 2012
Pharmaceutical Education & Research Center (PERC), North Carolina
Performed routine testing of tablet and capsules by dissolution, disintegration, content uniformity and weight variation testing as per USP monographs.
Perform stability testing for solid dosage forms as per the SOPs.
Performed routine raw material (API and excipients) testing using HPLC for assay/purity, water content by Karl Fischer titrimetry, FTIR, DSC and TGA.
Performed pre-formulation studies for tablet formulations along with flow property testing (angle of repose) using Flodex.
Drafted and reviewed batch records and SOPs, performed and documented major and minor cleaning validation of equipment in GMP areas and assisted in maintaining chemical inventory records.
Lab Assistant Aug 2011 - May 2012
PERC, North Carolina
Trained students in operating instruments like HPLC, GC, UV-Vis, Malvern Zetasizer Nano, USP dissolution and disintegration apparatus, FTIR, TOC, Karl Fischer, DSC, TGA and lyophilizer.
Trained students in a GMP qualified environment on dissolution testing, stability testing, manufacture of tablets using single-station tablet press, capsule filling, powder blending and lab scale manufacture of a few common liquid and semi-solid dosage forms.
Pre-formulation characterization of a liposomal component for enhancing formulation stability:
As a part of North Carolina Biotechnology Center (NCBC) grant performed systematic analysis of highly mesomorphic DMPC, a component of a liposomal formulation using FTIR, DSC, TGA, HSM and PXRD, developed and validated a HPLC method to analyze the chemical stability of the heated phospholipid and developed a stable intermediate form for formulating a liposome.
Analytical/Bio-analytical: Moisture sorption analysis, TLC, Franz Cell Diffusion, DPI testing using cascade impaction, Nanodrop, Bio-analytical skills include Bradford's assay, BCA, Endotox assay, aseptic techniques, environmental monitoring in manufacturing area, USP water analysis, gel electrophoresis and confocal fluorescent microscopy.
Manufacturing: Tablet press, capsule filler, Bee homogenizer, lyophilizer, rotary evaporator, Brookfield viscometer, stability chambers, sterile filtration, heat sterilizer and microencapsulation.
Software: MS office, Empower 3 chromatographic software, Softmax Plus, Graphpad PRISM, JMP (SAS) software (DOE) and Chemdraw.
MS in Pharmaceutical Sciences (Industrial pharmacy) Campbell University, NC May 2012
BS in Pharmacy, Osmania University, INDIA May 2010
Liquidia Technologies Excellence Award
Graduate Student Leadership Award, Campbell University.
AAPS – National member, Chair of Campbell University AAPS Student chapter.