Development Quality Control

Tushar Wane

** ******** ****** ***#*** Malden, MA 02148 **********@*****.*** 978-***-****

Profile

Strong hands on experience in analytical techniques for protein characterization and development

Method development, method validation, routine analysis for protein drug molecules in pipeline

Techniques: HPLC (SEC, IEX, HILIC,RP), CE-SDS, iCE (image capillary electrophoresis), SDS-

PAGE, ELISA, Activity Assays, Protein-A HPLC Titer, UV-Vis Spectroscopy, Solo VPE, Peptide

Map, N-Glycan, FPLC(IEX, Affinity, SEC)

Strong organizational skills, work independently/team, detail oriented, strong oral and written

communication skills

Software/Instruments Skills: Empower, HPLC (Waters, Agilent), ChemStation, UPLC, LIMS,

32 Karat CE software, iCE280

Relevant Experience

Associate Scientist II Jan. 2014-Present

Analytical Development, Biogen Idec Cambridge, MA

Method development for capillary gel electrophoresis using laser-induced florescence (LIF) as

mode of detection to determine purity and characterization of monoclonal antibodies, fusion

proteins, antibody drug conjugates

Optimization various conditions (pH, D/P ratio, time, temp etc.) and to compare the data for CE-

SDS analysis using UV detector and florescence detector to achieve the goals of the project

Supporting routine analysis for DS, DP, stability samples using ELISA, SEC-UPLC, TCA, activity

assays (blood coagulation factors)

Working in cGMP environment following USFDA, ICH regulations and supporting development of

biological drug molecules in pipeline

Data analysis and detailed documentation of all processes for assay development and routine

analysis using electronic lab notebook (LIMS)

Troubleshooting (instruments, software, methods), critical data analysis and data review

Associate ScientistJan.2013-Dec. 2013

Analytical R and D, Pfizer PharmaceuticalsAndover, MA

Performed process support, formulation and stability support, product characterization for mAb’s,

fusion proteins, antibody drug conjugate (ADC’s), small molecules using routine analytical assays

Supported various projects using analytical techniques such as SE-HPLC, IEX-HPLC, HILIC-

HPLC, Protein A HPLC Titer, Peptide Mapping, N-Glycan

Determined identity, purity and quality of monoclonal antibodies, in-process development protein

samples using gel electrophoresis techniques such as- SDS PAGE, Capillary Gel Electrophoresis

(nrCGE, rCGE), image Capillary Electrophoresis (iCE)

Characterized small molecules (Excipient Assays) in drug substance and drug products

Involved in Method development, method validation activities for developmental work

Purification of proteins (monoclonal antibodies, fusion proteins, ADC) - ProA Purification

Determined the concentration of fusion proteins, monoclonal antibodies and other proteins by Solo

VPE, UV-Vis and Nano drop

Summer Intern, Natick, MA

Protein Purification, Xtal Biostructures Inc Jun. 2012- Aug. 2012

Protein expression at pilot scale in appropriate media (up-stream process)

Purified several proteins usinganalytical methods- FPLC/AKTA (IEX, Affinity, SEC)

Successfully characterized by SDS PAGE, Western Blot and analytical SEC.

Developed expression conditions by Monitoring the cell growth (OD) by UV-Vis Spectroscopy

Massachusetts Biomanufacturing CenterUniversity of Massachusetts, Lowell, MA

Analytical Development and Protein Purification Oct. 2011-Mar. 2012

Successfullymonitored concentrations of samples (glucose, acetate) by HPLC

Purified protein by Immobilized Metal Ion Affinity Chromatography (IMAC Column)

Supported E-coli fermentation at 20L scale;supported assay development

Developed growth curves, carbon source depletion curves and acetate accumulation by HPLC

Tracked product/protein concentration using UV-Vis Spectroscopy, SDS PAGE.

Quality Control Officer Jan.2011- Jun. 2011

Hexagon Nutrition Ltd., Dindori, India

Successfully monitored various processes (IPQC) to maintain the quality according to GMP,

HACCP practices.

Tested the quality of product/samples using analytical methods such as KF-titration, UV-

Monitored the manufacturing process for aseptic drug products

Successfullyensured adherence to quality by preparing and updating SOPs and reports

Undergraduate Capstone Research Project 2009

“Development and In-Vitro Evaluation of Colon–Specific Formulation for Orally Administered Diclofenac Sodium”

Project Goal: to develop colon specific drug delivery system.

- Utilized multiple polymer combinations to prepare various classes of tablets by wet granulation

- Tested tablets for maximum drug release using tablet dissolution test USP apparatus in simulated

body fluids (gastric, intestinal and colonic)

- Characterized dissolved samples using UV-Spectroscopy to estimate concentration at regular

intervals

Education

MS Analytical Chemistry, Biochemistry Dec. 2012

University of Massachusetts, Lowell, MA

Relevant Courses:Advanced Analytical Chemistry,Chromatography, Biochemistry-I and II, Protein Chemistry,

Immunology, Pharmaceutical Biochemistry, Cell and Microbe cultivation.

BS Pharmaceutical Sciences Jun. 2009

GovernmentCollege of Pharmacy, Amravati

Relevant Courses:Pharmaceutical Analysis, Organic Chemistry, Medicinal Chemistry,Bio pharmaceutics and

Pharmacokinetics

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