* ***** *. **********, *.Sc.Ed; Ph.D.

*** ********* ******* ***** *****:abiigs@r.postjobfree.com Cell: 636-

***-****

St. Charles, MO 63303

www.linkedin.com/in/raghupandurangi123 Home: 636-***-****

PROFESSIONAL SUMMARY

Innovative and proactive ANALYTICAL CHEMIST with 15 years of experience in

drug design, characterization using analytical techniques, bioanlytical and

radiolabeling expertise. Proven track record in drug development and

directing and building strong multidisciplinary team to achieve corporate

goals. Expertise in assays, method development, validation under GLP & GMP.

Directed group of chemists and biologists. Principle investigator for

several projects, Selected appropriate methodology with CRO, Successful,

passionate, proactive and multitask professional.

KEY ACCOMPLISHMENTS

. Designed and developed analytical method development for newly

conceived "Embedded Therapy" project (market potential billion $).

Result: proof of principle and Go for the project to preclinical,

Established collaborations with Merck, Genentech and academicians for

co-development of diagnostic products saving millions of dollars and

time.

. Successful Phase 0 meeting the bonus objective from VP level to

director level.

. Expertise in HPLC, UPLC, FPLC, DSC, TGA, GC/LC/MS/FTIR/NMR, PAGE,

. 10 years of technical direction in targeted drug development,

formulation, bioconjugation, preclinical analytical development for

new drugs.

. Development of assays, writing protocols, review documents, reports.

. 15 years of directing and managing the group from BS- Ph.D. levels

both in chemistry and in biology: Additional cross functional

experience in identifying, designing assays with CROs.

. Spearheaded R & D with evaluation of external technologies (4),

licensing opportunities (3).

. Evaluated, validated analytical methods developed with CRO, Provided

key data points to upper management for their Go-No go decision.

. Provided leadership, defined objectives for reporting people

(chemistry and biology), performance reviews (direct reports 4 in

Covidien (in turn 4-5 under each), 5-6 direct reports in

Shering/Berlex-Germany/USA (in turn 3-4 under each). API release

specifications, batch record, accelerated stability of DS/DP and

clinical kits.

. Directed Impurity profile, stability issues, manufacturing issues,

clinical samples for injectable, sterile kits from preclinical to

phase II.

. Commercialized photo cross linking agent for PIERCE company.

. Exercised Safety standard guidelines in GLP, GMP laboratory

compliance.

. Several successful board presentations involving sector president, VP

for funding new programs, equipment and personnel.

. 20 years of total scientific leadership (10 industrial + 10

academic, defined objectives for the 6-10 team members of chemistry,

pharmacology and biology personnel) in targeted drug development. 34

Publications, 56 Oral presentations (31 invited), 15 Collaborations,

9 Patent disclosures, 4 Book Chapters, 6 Posters & 1.5 million $

funding. Nominated for FACC.

. Product Experience: USP/EP, R & D, CMC, IND, NDA, FDA/EMEA

interactions.

CORE COMPETENCIES

Organic Synthesis Analytical Method Development Kits

Manufacturing

Busines Development Impuirty Profile, Stability Protocols Clinical QC

HPLC/LC/MS/GC CMC for IND & NDA Regulatory Issues

WORK EXPERIENCE

CONSULTANT: Guide Point Research Consultants, NY

2009- (http://www.guidepointglobaladvisors.com)

Clients: Walker Smith Capital, Biotechs

SCIENTIST: Danforth Plant Science Center, St Louis.

2009 - Present

Analytics of antimicrobial peptides, HPLC-FPLC method development for

protein expression, site directed mutagens & purification, Kinase

expression related to resistance development, phosphorylation Assessment

by proteomics/MS, PAGE, ELISA.

COVIDIEN (PHARMACEUTICALS & IMAGING)

2004- 2009

TECHNICAL FELLOW, PROJECT LEADER.

PROJECT; Embedded Therapy: Targeted therapy/Imaging combination

Validation of biomarkers with new analytical

techniques to identify lead drug candidates.

. Successfully evaluated proof of concept for Phase 0 tied to bonus

objective: Go decision.

. Established contract with Charles River discovery and imaging services

to validate biomarkers.

. Impurity profile, degradation product identification, impurity

standard preparation & Stability criteria.

. Cross functional product support with marketing and sales people

($100 million sales).

. Validated new therapeutic targets for cancer therapy

. Managed budget, direct reports, defined objectives and integrate

activities of synthetic, analytical and biology functional groups.

. Outsourced manufacturing to sites in India, quality control and GMP

product out for pharmacies in USA, resolving issues within group,

contractors and collaborators.

COVIDIEN (PHARMACEUTICAL & IMAGING) 2004-

2008

PRINCIPLE RESEARCH SCIENTIST; CO-DIRECTOR

PROJECT: Apoptosis Imaging, Synthesis of API, formulation and analytical

method, stability

. Managed the budget for the project. Established 5 Collaborations in 2

years; Preclinical data on variety of targets/animal models for Go- No

Go decision.

. Synthesized As, B, P based cell death PDI (protein di isomerase)

binding biomarkers, Caspase based apoptosis probes: Go decision for

PDI.

. Evaluated Aposense apoptosis imaging technology NST, Israel, No Go

decision.

. Generated cross functional contribution of characterizing radiolabeled

impurities for "generic drug" to fulfill ANDA application (currently

marketed with $ 100 million sale).

. Reviewed CMC documents for Cardiolite generic drug.

. Directed analytical personnel (cell binding assays, flow cytometry,

standards characterization, imurity profile, SOPs) for cell death

imaging and embedded therapy projects.

. 4 reporting (M.S. & Ph.Ds, under whom 4-5 at BS level. Mentored 4-5

Scientists.

. Expertise in analytical tools: NMR, HPLC/MS, LC/MS, TLC, CE, IR,

UV/Visible.

. Performance evaluation for, new hires, new funding proposals, part of

cross functional teams,

. Product demonstrations in international conferences, business

development meetings with licensable products.

BERLEX/SCHERING AG/BERLIN; PRINCIPLE INVESTIGATOR. 2000 - 2004

PROJECT: Analytical development of peptide and Aptamer based imaging

agents

. Successfully taken Aptamer product (Breast cancer imaging agent) from

bench level to Phase 1 clinical level.

. Several formulations, In vitro assays, analytical methods development

for peptide and oligo based radiopharmaceuticals.

. Characterized low level peptide impurities and assigned structures and

mechanism for FDA and EMEA (European) questions.

. Authored SOPs and technical reports to support FDA filings.

. Evaluated bioassays for specificity, sensitivity, linearity, limit of

detection, limit of quantification.

. Coordinated with Berlin team and reviewed CMC for IND and NDA. (high

visibility)

. Established stability program, problem solving and complete project

management.

. Transferred Technology to Berlex (QC, NJ), Berlin (Germany) and France

for Tox studies (phase 1 clinical).

. Reporting structure: 6-8 people from two different sites.

. Expertise in HPLC, TLC, UV/IR, NMR, LC-MS/MS, SDS-PAGE, wet chemistry

techniques, preparing reports.

. Analysis for water content, residual solvent analysis, particle

analysis.

Assistant Professor, Chemistry Department, University of Missouri,

Columbia. 1996-2000

Adjunct Assistant Professor, Internal Medicine, University of Missouri,

Columbia.

. Established radiopharmaceutical program @ UMC, External funding,

Training post doctoral fellows, Published in JOC, Bioconjugate Chem,

Bioorganic Chem, JACS.

. Reviewer for JACS, JOC, Inorganic Chemistry, Bioorganic Chemistry,

Bioconjugate chemistry, Tetrahedron.

. Directed post-doctorals (5) and students (6).

Research Assistant Professor

1991 - 1995

Chemistry & Radiology, University of Missouri, Columbia.

with Prof. Wynn Volkert Inventor of "Ceretec" and Quadrimet", brain imaging

and pain palliation agent, Center for Radiological Research & Department of

Radiology, University of Missouri, Columbia.

. Organic photochemistry, Synthesis of chelating agents, organometallic

chemistry, in vitro binding, in vivo imaging, IC-50, ID50

measurements. Radiolabeling (99mTc-186Re,105Rh, 123I, 125 I,18F,

64Cu). Mab, Fab labeling with dyes, radioprobes, radio-immuno assays.

Bioconjugation, Assessment of retention of binding activity of

immunoconjugates. Analysis of crosslinking products using ELISA.

Research Associate 1987-1991

National Institute of Occupational Safety and Health, (NIOSH) & West

Virginia University.

. FTIR/Photoacoustics on silicosis and pneumoconiosis.

EDUCATION

Post doctoral Research: Radiology and Internal Medicine, University of

Missouri, Columbia.

Ph.D. - Chemistry, Indian Institute of Science, India.

M.S. - Organic Chemistry, Mysore University, India.

B.S. - Physics/Chemistry/Mathematics, India.

HONORS

Dr. J. C. Ghosh Gold Medal for the Best Ph.D. Thesis.

A Citation and Award for the Best Paper Published in Journal of Chemical

Society, 1989.

5 year Excellency award from Covidien.

PROFESSIONAL ASSOCIATIONS:

ACS (Med. Chem. section), Society of Applied Spectroscopy, Society for

Noninvasive Imaging and Academic Molecular Imaging (SNIDD), EANM (Europe).

Society of Nuclear Medicine (SNM), Associate member of ASNC (2007).

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