Data Quality Control

Veera Raghavan

****, ***** **, ********# *- *B ( MORRIPLAINS, New Jersey 07950

Mobile: 862-***-****. HOME: 973-***-****. Office: 609-***-****

( E-Mail:

*************@*******.***

SUMMARY OF SKILLS

. Expertise in method development, optimization and validation and clinical

knowledge. 10+ years of experience in the pharmaceutical and Bio-pharma

industry.

. Good Knowledge of general clinical research including Informed consent,

Data verification, Data mining, Investigator site issues, important

milestones and strategies to ensure timelines are met. Good knowledge of

Bio-equivalence and clinical studies. In-depth knowledge and

understanding of USP, ICH, GLPs, cGMPs and applicable FDA guidelines and

regulations. Hands-on experience with several successful regulatory

filings for solid oral dosage products as well as protein drugs. Good

knowledge of GCP, GLP and Declaration Helsinki and other Regulatory

requirements. Good knowledge of working with CROs and communicating with

the CROs for the required data and related documents related the studies.

. Highly motivated and reliable performer with great sense of

responsibility; excellent team player with very positive attitude;

willingness to take on new and varied projects and ability to handle

changing priorities and deadlines; detail-oriented, enthusiastic and fast

learner. Good knowledge of Clinical Site and Clinical study monitoring,

patient (subject) recruitment for the clinical trials.

. Strong verbal and written communication, interpersonal and computer

skills. Effective project management skills and strong multi-tasking

capabilities.

. Experienced in resolving compliance issues and performing out of

specification results investigation. Qualified as an investigator using

Kepner-Tregoe (KT) method.

. Thorough knowledge of clinical trial aspects.

. Demonstrates effective interaction and communication skills with

appropriate levels of organization and with the external audiences.

. Extensive expertise in Compendial raw material release testing and

familiarity with product changeover cleaning verification using TOC and

HPLC methods.

. Proficient in various analytical techniques including HPLC, GC, UV/VIS,

TLC, KF, pH, Dissolution, FT-IR, IR, Auto titrator, Microscopy, Micro

Flow Imaging (MFI), Nanosight, Particulate matters by Light Obscuration

techniques as well as wet and physical chemistry. Familiar with Waters

Acquity UPLC system.

. Experienced in Chromatographic software systems such as Waters

Millennium/Empower and Total Chrome/Turbo Chrome. Proficient in the use

of a variety of software including Windows XP/Vista/7, Microsoft Office,

Labware LIMS, and Trackwise.

PROFESSIONAL EXPERIENCE

BRISTOL-MYERS SQUIBB COMPANY,

Biologics Manufacturing and Product Development, Pennington, NJ

Associate Research Scientist II Oct. 2012- Present

. Performing assays for Drug products, Drug substances, Ready to use, High

concentration and API using UV spectrophotometer, pH meter, Osmometer,

HIAC, KF apparatus, Microscopes, Viscometer and Densitometer in GMP

complaint fashion.

. Follow SOPs for release of drug substances, drug product and in process

product, in a timely manner. Work in a collaborative fashion with other

groups.

. Ensure laboratory is clean, safe and GMP complaint. Maintain notebooks

and as per SOP. Maintain Velquest and Symx data in accordance to GMP.

. Validate and Qualify different methods by performing required testing.

. Trending data for stability samples and reporting data using PDLIMS.

. Participated in Technology transfer activities, Forced degradation

studies and Use-Time studies.

. Work with the vendors to get more knowledge about the recent instruments.

Ensure the lab equipments are calibrated in a timely manner. Overlook

Instrument calibrations performed by vendors and review the data prior to

release of instruments for use.

. Ensure the Quality events are closed in a timely manner. Qualified

Investigator in the group for Trackwise.

. Worked on the template creation for various methods for Velquest projects

and Symx ELN.

. Co-ordinate GMP glassware and Labware washing process. Person

responsible for smooth functioning of the stock room.

. Completed certificate course for Technical writing.

Associate Research Scientist I Sep. 2006- Oct.2012

. Performing assays for Drug products, Drug substances, Ready to use, High

concentration and API using UV spectrophotometer, pH meter, Osmometer,

HIAC, KF apparatus, Microscopes, Viscometer and Densitometer in GMP

complaint fashion.

. Developed and validated Total Organic Carbon (TOC) testing methods for

MDX-1100, MDX-1105, Elotuzumab, and IL-23 in support of cleaning

verification program in Hopewell Clinical Manufacturing and Syracuse

Commercial Manufacturing.

. Follow SOPs for release of drug substances, drug product and in process

product, in a timely manner. Work in a collaborative fashion with other

groups.

. Ensure laboratory is clean, safe and GMP complaint. Maintain notebooks

and as per SOP. Maintain Velquest and Symix data in accordance to GMP.

. Validate and Qualify different methods by performing required testing.

. Trending data for stability samples and reporting data using SQLLIMS and

PDLIMS.

. Participated in Technology transfer activities, Forced degradation

studies and Use-Time studies.

. Work with the vendors to get more knowledge about the recent instruments.

Ensure the lab equipments are calibrated in a timely manner. Overlook

Instrument calibrations performed by vendors and review the data prior to

release of instruments for use.

. Ensure the Quality events are closed in a timely manner. Qualified

Investigator in the group for Trackwise.

. Worked on the template creation for various methods for Velquest projects

and Symx ELN.

. Presented Posters in BMSRIAC and R and D Symposiums.

. Co-ordinate GMP glassware and Labware washing process. Person

responsible for smooth functioning of the stock room.

Assistant to Analytical Project Team Leader

2012 - Present

. Apprentice Analytical Project Team Leader (APTL) for MDX-1105 and MDX-

1106 (Nivolumab). Helped in managing all analytical aspects of the

development of this product.

. Worked with contract laboratory to manage the testing and release of MDX-

1105 and MDX-1106 samples.

. Worked on data mining and reviewing the outsourced lab Analytical

documents.

. Worked on Nivolumab stability data delivery activities to ONO, Japan.

. Worked closely with the APTL, ARL and the BLA submission team for

Nivolumab BLA submission and Minor band entries.

Par Pharmaceutical, Spring Valley, NY

Quality Control Chemist (Stability) Nov. 2005- Sep. 2006

. Perform assay, purity, dissolution profile, IR testing, ID testing and

LOD testing, uniformity of dosage, blend assay, blend uniformity tests

and particle size testing on the solid and liquid dosage form, IPT

samples, flocculation testing on the flocculated suspension preparations

as per USP, NF and in-house procedures using UV, HPLC, FTIR, Malvern

particle size analyzer, Microscope and Karl fisher .

. Perform calibration of pH meter and balances.

. Trained new analysts to perform day to day analysis using HPLC, UV, TLC,

FTIR, Karl fisher, and Malvern particle size analyzer.

. Ensured compliance cGMP and participated in troubleshooting and problem

solving. Ensured good practices in maintaining the lab records.

Actavis Pharmaceutical Inc., (Formerly Amide Pharmaceuticals Inc.,) Totowa,

NJ

Associate Scientist - R&D Oct. 2004- Nov. 2005

. Perform Method validation, Process validation on the finished and bio

batches, method validation sample batches, analyze the effect of UV

photolysis, Acid-Base degradation, Peroxide effect, and Heat degradation,

triple point peak purity studies on API and finished product using PDA as

per in house methods and SOPs.

. Perform method development for related substances, cleaning validation

studies as per SOPs using HPLC with RI detector. Performance

Qualification on HPLC using Totalchrom and Turbochrom.

. Perform analysis of Assay, content uniformity, blend uniformity, blend

analysis, time mixing study, related compounds study, dissolution and

dissolution profile of finished products, stability products API as per

in-house, USP, NF, and manufacturers methods using HPLC and UV/Vis and

auto titrator. Perform in-house standard recertification as per

procedures.

. Person in charge for in-house standard recertification and maintenance of

data.

. Ensured compliance with cGMP and participated in trouble shooting and

problem solving. Perform calibration of pH meter and balances.

. Trained new analysts to perform day to day analysis using HPLC and UV.

Nature's Bounty, (Formerly Nutro Labs,) South Plainfield, NJ

Chemist Jun. 2002- Oct. 2004

. Perform assay, time release profiles, moisture content, estimation of

loss on drying

. of nutriceutical finished products, Blends and raw materials according

to USP, NF and in-house methods using, HPLC, UV, Wet chemistry, TLC and

auto titrator.

. Ensured compliance with cGMP and participated in trouble shooting and

problem solving

. Trained new analysts to perform day to day analysis on HPLC, UV,

Titration, and TLC

Cipla, Bangalore, India

2000-2002 Chemist

. Performed analysis of finished products according IP, USP, and NF

. Volumetric analysis of Ascorbic acid using Iodine solution

. Analysis of Ibuprofen, Acetaminophen, Theophylline, Thiamine, Riboflavin,

Niacin, Pyridoxine, and Pantothenic acid in finished products by HPLC

. Analysis of Vitamin E by GC

. Ensured compliance with cGMP and participated in problem solving and

troubleshooting.

EDUCATION

Masters in Science, Clinical Research Organization Management (CROM)

. Drexel University, Philadelphia, PA

TECHNICAL SKILLS

Instrumentation

HPLC and UPLC Karl-Fisher

Gas Chromatography Electronic Microscope

UV/VIS Atomic Absorption Spectroscopy

FT-IR Micro Flow Imaging (MFI)

Dissolution HIAC

Microscopy Nanosight

Software

Windows XP/Vista/7 Agilent ChemStation

Microsoft Office Trackwise

Waters Empower Waters Millennium

Total Chrom Labware LIMS

Turbo Chrom Client VelQuest

Services UV Win lab

Titrino work cell

Dispro Ominic

PRESENTATIONS

BMS Internal Presentations

. R. Vasudev, V. Raghavan, A. Dubey, A. Galvan-Gonzalez, Appearance of

Liquids: Appearance of Liquids For Biologics, Poster Presentation,

BMSIARC, June, 2007.

. V. Raghavan, A. Dubey, A. Chynoweth, and M. Grace, Protein

Concentration: Critical Parameters to consider when Evaluating Protein

Concentration of Proteins and Antibodies Such As Abatacept, Belatacept

and AntiCD-137, Poster Presentation, BMSIARC, June, 2008.

. V. Raghavan, A. Dubey, A. Chynoweth, M. Grace, Appearance Of

Biologics: Analytical Method to Quantitate the Color, Clarity and

Degree of Opalescence in Biological Solutions (Abatacept, Belatacept,

AntiCD-137 And Ipilimimumab) Which meets Pharmacopoeia, Poster

Presentation, BMSIARC, June, 2008.

. A. Dubey, V. Raghavan, A. Chynoweth, and M. Grace, Sub-Visible

Particles: Identification of Key Factors for the Accurate Evaluation

of Sub-Visible Particle Analysis by the Light Obscuration Technique in

Biological Samples, Poster Presentation, BMSIARC, June, 2009.

. R. Vasudev, A. Dubey, V. Raghavan, S. Mathew, and N. Afonina, Total

Organic Carbon Analysis: An Efficient Technique for Cleaning

Validation of Biologics Using Rinse, Swab and Sonication as Analytical

Tool, Poster Presentation, BMSIARC, June, 2011.

AWARDS

. BMS Spot Award, 2009 for support of the Use Time Study for Belatacept

Drug Product.

. BMS Spot Award, 2009 for supporting the Qualification of Lancer Glass

Washer.

. BMS Spot Award, 2010 for TOC validations for MDX 1100, and Elotuzumab.

. BMS Spot Award, 2010 for Nivolumab stability data delivery to ONO,

Japan and BLA activities.

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