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Sumati
US-Massachusetts
Formulation Associate II
My goals are to gain further chemical,product, and regulatory knowledge to enhance my personal development so that I may eventually learn how to manage a team.
OBJECTIVE: Qualified Research Scientist seeking to work for a dynamic pharmaceutical/biotechnology company as a Senior Research Associate where hands-on experience in the formulation development, process optimization and characterization of products is desired.
EDUCATION:
oGeorge Washington University, Washington D.C, USA
Masters of Science in Genomics & Bioinformatics Aug’05May’07 oD.A University, Indore, INDIA,
MS in Biotechnology
Jun’02- May'04
oSt. Xavier’s, Ahmedabad, INDIA
Bachelors of Science in Biochemistry Jun’99 – May’02
EXPERIENCE:
Formulation Associate - II, Formulations Group, Altus Pharmaceuticals, Cambridge, MA Mar’08 - Present
•Responsibilities include supporting liquid and solid protein formulation development, including micro crystalline protein suspensions, tablets and capsules.
•Performed protein crystallization, complexation, crystalline suspension formulation and characterization.
•Prepare pre-clinical study materials and perform stability studies. Implement appropriate analytical methods to monitor protein purity, stability and activity.
•Analyze, interpret and communicate experimental data to project teams in the form of oral presentations and written technical reports.
•Support Biopotency studies in terms of Test Article preparation and analysis
•Support Formulation and Container closure development
Formulation Associate, Formulations Group, Altus Pharmaceuticals, Cambridge, MA Jul’07 – Mar’08
Responsibilities include supporting Formulation development, analyzing pharmaceutical samples, processing raw data and documenting results.
•Primarily involved in testing and validating stability formulation samples. Method used to perform these analyses includes analytical instruments such as Anion-Exchange Chromatography, Spectrophotometer, Dissolution Assays, Zeta Potential, Particle Size Dispersion, pH and Microscope.
•Trained to perform Activity Assays on Lyophilized powder and Suspension to support pre-formulation work.
•Characterization of lyophilized product to generate stability data.
•Moisture analysis of lyophilized powder using Karl-Fischer Instrument.
•Generation of dissolution profile using a dissolution apparatus.
•Using TA-XT plus to study bioadhesive, hardness and disintegration properties of a tablet.
•Familiarity with various solid dosage forms-tablets and capsules.
Formulation Intern, Altus Pharmaceuticals, Cambridge, MA
Jun’06 –Sep’06
•Prepared formulations, performed analytical testing, and data analysis
•Develop methods for the analysis of formulations such as HPLC, Moisture and other physical characterization techniques
•Performed pH/solubility profile, Excipient compatibility studies, evaluation of prototype formulations to ensure compatibility and desired outcome.
ACADEMIC PROJECTS:
•Under the supervision of Dr. Tim Mc.Caffrey conducted methylation studies on the LINE1 promoters in the aorta of old and young Fisher 344 rats. The results showed that there is a significant increase in the CpG methylation at three particular sites and this might be a consequence of aging. (MS Thesis)
Nov’05- May’07
.Large scale purification of MsGyrA::C3ScFv and MsGyrB from bacterium M. tuberculosis. (IAS Fellowship)
May’03 – Sep’03
•Purification, Photochemical crosslinking and refolding studies on Pf Triose Phosphate Isomerase which was extracted from malarial parasite Plasmodium falciparum that had been cloned and expressed in E. Coli.(Summer Studentship, Indian Institute of Sciences, INDIA) May’01 – Aug’01
•Research Methodology and Genetic Engineering techniques used in EF gene study in case of Bacillus Anthracis (Summer Studentship, JNU, INDIA May’00 – Aug’00
SKILLS AND COURSES:
•Proficient with AEX, SEC and RP-HPLCs (Agilent), MS (MALDI), UV-Vis Spectrophotometer (Agilent, Beckman Coulter, Thermo Scientific GENESYS), Fluorescent Spectroscopy and Microscopy
•Developed methods for the physical characterization analysis of formulations using Osmometer, Zeta Potential, Particle Size Dispersion, Karl Fisher, Texture Analysis using TA.XT, Distek Dissolution Apparatus.
•Hands-on experience in using Recombinant DNA technology such as Transfection, Transformation (diffèrent types of PCR) and Purification ; Automated Sequencing (Sequencer) ; Purification (Northern/Southern blotting) and Characterization of Proteins, IEF and SDS-PAGE.
•Experience in maintaining plant and animal cell lines using cell culturing techniques for adherent and non-adherent cells; freeze drying and cell counting.
•Communicate effectively and follow detailed written and verbal instructions.
•Cooperate with coworkers within an organized team environment or work alone with minimal supervision Creative problem solver that addresses challenging formulation issues.
•Self starter, proactive individual with keen attention to detail and strong people skills, who works well independently or in cross functional teams.
•Maintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOP.
•Manage time effectively to complete assignments in expected time frame.
•Supervised and mentored junior level interns
•Stability Testing of Proteins, Peptides & Other Biomolecules
•cfPIE course module. cGMP Training at Altus Pharmaceuticals
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