Quality Control Management

Experienced scientist with doctoral degree in biochemistry with more than

* ***** ** ********** ********** (2 years bio-pharmaceutical industry)

working on originator and bio-similar molecules in areas of protein

formulation, drug product process development, bio-analytical & biophysical

methods and primary container development strategy for proteins.

. Expertise in analytical chemistry, pharmaceutics and able to diagnose

the problem and lead a team to generate pragmatic solutions. Ability

to independently generate precise, protocol, technical reports,

summaries and memos as well as follows protocols, documents results

and reviews summary reports.

. Involved in identifying and developing drug product manufacturing

processes including bulk protein freeze/thaw, liquid mixing, sterile

filtration, container filling, visual inspection, as well as

transportation / cold chain management of parenterals.

. Highly skilled in various optical microscopic techniques, particle

size distribution and particle characterization (Optical

Stereomicroscopic particle analysis, SEM/EDS, AccuSizer780, Low volume

HIAC, FPIA, NTA, Archimedes, Micro Flow Imaging as well as Visual/

enhanced visual inspection methods. Working experience using

Spectroscopic techniques including IR/FTIR.

. Independently developed sub-visible particle methods for analysis of

protein biopharmaceuticals. Micro-flow imaging method currently being

used for stability testing. Drafted study protocol and lead analyst

training for enhanced visual testing of Drug Product.

. Design and Execute FPLC protein purification experiments

(AKTA/Unicorn) and apply the results to process development and

optimization.

. Bio-analytical method development and validations (HPLC, UPLC and GC)

for release, in process, and stability of API, excipients as well as

drug products (small molecule and proteins/ peptide). Purification and

characterization of related substances/ impurities in DS and drug

product. Performs pre-validation studies, validations and

robustness/optimization for analytical methods.

. Responsible for the technology transfer of processes to domestic and

international sites, including the identification, design, and

execution of at-scale process studies, as well as developing and

ensuring adherence to project schedules.

. Cellular assays to measure viability, proliferation, and apoptosis

(cell based assay, enzymatic assay, aseptic and cell cultures both

suspension and attached). Working experience in patch clamping, ELISA,

SDS-PAGE, western blotting and in conducting cell signaling pathway

studies.

. Several years of experience working in high performance teams on

commercialization of pipeline molecules in addition to leading a sub

group of analyst(s) for emphasizing quality control, laboratory

operation, project management, method transfer, product development

and document writing.

Work Experience Summary:

Contract Scientist: August, 2011 to Sept 2013

Hospira, Inc: Global Pharma Biologics R&D, Lake Forest IL-60045

Significant contributions in biophysical characterization of proteins and

protein formulations, method development, transfer protocols/ SOP auditing

GMP/GLP/GDP work.

Major Contributions:

. Maintains laboratory instrumentation and systems according to cGMP

requirement/

. Bio-similarity and comparability studies on therapeutic protein

formulations.

. Developed various methods for early detection and identification of

glass lamellae in drug products using various techniques including

Micro Flow Imaging by applying morphological filters for separation of

sub population of glass particles/ silicon oil from other particles.

. Developed methods for characterization of protein aggregates/sub

visible particles distribution both at the level of sub micron (<1?m)

using NanoSight and Archimedes and micron (2-25?m) using AccuSizer,

Low Volume HIAC and Micro Flow Imaging.

. Conducted shear stress and membrane filtration, filter flush and

needle flush studies on protein drug product.

. Involved in investigations of method performance, and OOS and OOT

results generated in Global Biologics R&D.

. Developed and execute protocol for analyst training/ qualification for

visual/ enhanced visual inspection.

. Characterized visible/ sub visible particle in protein drug

formulations using various orthogonal methods/ approaches.

. Glass vial durability testing and glass de-lamination mitigation

strategies.

. Identified and developed drug product manufacturing processes

including bulk protein freeze/thaw, liquid mixing, sterile filtration,

container filling, visual inspection, as well as transportation / cold

chain management of parenterals.

Stability database evaluation and assessment:

. Stability testing of protein drug product as well as maintain a

compliant, audit ready LIMS stability data base. Perform data entry

and verification in LIMS system.

Education:

. MS in Biochemistry, University of Hisar Haryana-125004 (CCS HAU-

Hisar, India)

o MS- Dissertation "Isolation, purification and characterization of

major proteins from a promising cultivar of Cicer arietium (Chickpea)

and determination of nutritional quality".

. BS Biology, University of Himachal Pardesh Shimla-05 (India).

. Planning, Implementation & Documentation for ISO 9000 Quality

Management System from Indian Institute of Quality Management Jaipur-

India.

. Six Sigma White Belt Certificate of Achievement (2013) from Aveta

Business Institute-USA.

Analytical Expertise:

Demonstrated skills and trouble shooting experience in the following

techniques/ Instrument Equipment: HPLC, UPLC (Empower) instruments

with a variety of detection systems, FPLC (AKTA/Unicorn), GC/MS,

Stereo-microscopy (Using Image-Pro) analysis of particles, NanoSight,

Archimedes analysis, Low Volume HIAC, AccuSizer 780, MFI, various

types of electrophoresis including SDS-PAGE, capillary

electrophoresis, western blotting, ELISA, radioimmunoassay (RIA),

spectroscopy (UV/VIS, fluorescence, or CD of bio-pharmaceutical

compound.

Technical Expertise:

. Protein purification and characterization using various biophysical

tools. Design and Execute FPLC protein purification experiments

(AKTA/Unicorn) and apply the results to process development and

optimization.

. Analytical method development and full validation (HPLC/GC) for API,

excipients as well as drug products (small molecule and proteins/

peptide drug products).

. Purification and characterization of related substances/ impurities in

DS and drug product.

. Characterized visible/ sub visible particle in protein Drug

formulations using various orthogonal methods/ approaches.

. Analyst training/ Qualification for Visual/ Enhanced visual

Inspection.

. Glass vial durability testing and Glass De-lamination mitigation

strategies.

. Lipid analysis.

. Proficiency in general laboratory techniques, in vitro and in vivo

sample preparation for quantification in biological matrices. Small

animal surgical procedures, ex-vivo culture of blood vessels and cell

culture techniques.

Software Knowledge:

. Trained on required Hospira lab software tools.

. Demonstrated working experience using Empower chromatography data

software, eLN software from Accerlys, Clarity, LIMS, NuGenesis SDMS,

Origin 8.0 and JMP software.

Professional References:

. Krishnan Sampath,

Associate Director, Process Development

Global Biologics R&D, Hospira, Inc

275 North Drive, Lake Forest IL 60045, Tel: 224-***-****, Cell: 224-

358-1606

Fax: 224-***-**** E-mail: ********.************@*******.***

. Catherine A. Srebalus Barnes, Ph.D

Senior Director Bio- analytical Sciences,

Global Biologics R&D, Hospira, Inc

275 North Drive, Lake Forest IL 60045, Tel: 224-***-****, Fax: 224-

212-7905, E-mail: *********.**************@*******.***

. Sanjay V. Kamat, Ph.D. MBA

Associate Director, DP Engineering & Technology Transfer

Global Biologics R&D Hospira, Inc

275 North Drive, Lake Forest IL 60045 Tel: 224-***-**** (P),

Cell:224-***-**** E-mail: ******.*****@*******.***

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