MADHUP K. DHAON, Ph.D., PMP

**** ***** ********** *****

Phone: 847-***-**** Mundelein, IL 60060 E-mail: accdwl@r.postjobfree.com

www.linkedin.com/in/madhupdhaon/

PROJECT MANAGEMENT / PHARMACEUTICAL LEADERSHIP

• Highly motivated Leader and problem solver with experience in Project Management and Drug

/ Nutrition development. Directed and assisted the launch of drug candidates in the area of oncology, vascular,

pain management, and anesthetic from R&D to commercialization with sales in excess of $1.8 B. Skilled in

partnering with US and International CROs / CMOs for pre-clinical and clinical activities. Captured 20-80%

cost reductions on several products through innovative process improvements.

• Lean Six Sigma trained, formal trained and certified Project Management Professional (PMP)

with proficiency in implementing all project / process management challenges, and business improvements.

Portfolio Management, leadership, strategy development, contracts, project plans

Project Management

& tools like scope, timeline, team building, budget, risk management, conflict

Experience

resolution, meeting logistics, communication to stakeholders, procurement,

quality management, negotiations, stage-gate reviews, and PM software.

Supervised & trained scientists, new product development, small

Drug / Nutrition

molecules/peptides/proteins/nutrition products from inception to

Development Experience

commercialization (topicals, solid dosage, parenterals, inhalers); patents/FTO

issues, scale-up, analytical, design of experiments, validation, CMC activities on

IND/NDA/DMF, and PAI activities during FDA visit.

QbD, PAT, cGMP, formulation, FDA / ICH guidelines, QA policies and

Established Expertise

procedures, and various ISOs.

Patent attorneys, legal, finance, formulation, manufacturing, analytical, QA, SC,

Cross-Functional Team

regulatory, clinical, commercial, marketing, compliance, labeling, and FDA.

Interactions

Analytical instrumentations and data interpretation.

Analytical / QA and

QA activities with respect to raw materials, documentation audit, quality audits,

Manufacturing Experience

specifications, deviations, IRs, CAPA, gap analysis, and remediation efforts.

Manufacturing – chemical processes, nutritional formulations, lyophilization,

reverse osmosis (RO), aseptic processing, and large scale purifications.

PROFESSIONAL EXPERIENCE

BAXTER INTERNATIONAL, DEERFIELD, IL 2011-2013

Senior Program Manager, Project Management Organization (PMO)

Launch new parenteral nutritional therapies in form of mono or multiple chamber bags for adults and pediatrics

through various phases of clinical development. Manage Prime (for FTEs), and Cognos (for finance) systems.

Sales forecast for these products are expected to be ~$60-80 Million in US.

• Manage project management / technical activities in a highly matrix environment with forecast, budget

control, milestones, risk management, and stage gate reviews with internal stakeholders of R&D,

manufacturing, RA, clinical, QA, regulatory, labeling, marketing, and medical. Managed ~30 FTEs and a

budget of ~$12 Million.

Senior Program Manager, Innovation & Strategy

Championed project management plans, strategic plans, contracts ($100-500K) with CROs and Universities, KOLs,

managing core and technical teams, risk management, and manage technical aspects of bio-therapeutic proteins

from plasma in transplantation, Alzheimer’s (using a device), Acute Pancreatitis, and NEC area as POC candidates.

SPECTRUM PHARMACEUTICALS, IRVINE, CA – Director, Chemical Development 2011

Led the chemistry team on CMC / Project Management activities on novel oncology drug candidates

(Phase I-III), both small molecules and peptides and alliances with Drug Partners & CMOs.

ABBOTT, NORTH CHICAGO, IL 1990-2011

Section Manager, Project Management – Abbott Nutrition (2009-2011)

• Managed 10-11 pediatric (Pediasure, Similac, Pedialyte) and therapeutic nutrition Prosure (cancer),

Abound (diabetic foot ulcer), Nepro (CKD), Ensure etc. projects concurrently for US, Europe & emerging

markets. Sales of these products ranged from $30-50 Million each. Developed strategies for their market with

commercial team.

• Resolved issues with HD-Caseinates program with Fonterra, and streamlined Zone IV/II stability

program to save $400K in 3 months.

Project Leader / Research Investigator / Sr. R&D Scientist, Abbott (1990-2009)

Directed teams (4-12 scientists) and developed following 6 drugs (branded & generics, sales ~1.8B) from R&D,

scale-up, process justification (PJ), validation, CMC section, technical packages (for CMOs), cost analyses,

capacity analyses, DMFs, and transfer of technology to Abbott Manufacturing or a CMO.

Zotarolimus (DES), Midazolam, Ketorolac, Ketorolac-2000, Melarsomine, Pexiganan, and Lupron

• Achieved success in the launch of Anti-restenosis candidate ABT-578 (Zotarolimus) coated on

Drug eluting stent (DES, ZoMaxx, Endeavor) – Marketed in US (2008), sales in excess of $250 Million. (2

patents)

• Managed development of Midazolam, a pre-operative anesthetic drug from inception to

commercialization with ANDA. Initial sales of the drug were over 120 Million. (3 Patents)

• Directed Ketorolac (pain management drug) program in 2 stages, an initial launch in 1997, and a

secondary launch in 2000 with ANDAs. Initial sales of the drug were in excess of $120+ Million. (1 Patent)

Problems solved with Drug Development projects: Patent issues, synthesis, stability, degradation impurities,

analytical methods, specifications, increased process efficiency, reduce cost (by 85%), and transferred

technologies to CMOs, vendor management, and interactions with various functions from product inception to

its launch.

Peptide experience from R&D to multi-Kg Manufacturing

• Worked on solution and solid phase peptide synthesis of several peptide molecules, enzyme

inhibitors, Lupron (sales 1.2 B), designed and led a team of 12 scientists for a cGMP solution phase synthesis of

a 22-peptide (Pexiganan) in 3 years and transferred the technology to Manufacturing and CMOs. (5 Patents)

• Patented MIPS (minimal isolation peptide synthesis) technology & use of propylene oxide as an

acid scavenger in peptide synthesis (2 Patents).

PATENTS / PUBLICATION

Published 13 patents & 24 publications, 4 disclosures with patent department, several presentations at

symposiums, and at Abbott Technology exchanges.

AWARDS AND LEADERSHIP

• Chairman Team Award for Ketorolac launch (1997) – Two teams selected/year from ~75K

employees

• Volwiler Team Award (1998) – Two teams selected / year from scientific community

• Scientist of the Year (1998) Award in Chemical Development - Individual

• Stein Award for Outstanding Scientist (1999) in Chemical Development - Individual

• President Team Award Ketorolac (2001) – One award for the Division

• President Team Award ABT-578 (2004) - Two awards for the Division

• Impact Team Award on Cuno Filters (2004) - Two awards for the Division

• GPRD Division Team Award on ABT-578 (2006) - Two awards for the Division

• GPRD Team Excellence Award on commercial ABT-578 Process (2008) - Two awards for the

Division

Member of Stein committee (1997), Chairman Stein Committee (1998)

Chairman of Group Discussion Seminars for Chemical R&D (1995-2000)

EDUCATION

Ph.D.: Organic / Medicinal Chemistry, Central Drug Research Institute, India

PMP certification (PMI), Project Management (DePaul University)

Project Associate with Prof. Daniel H. Rich, School of Pharmacy - University of Wisconsin, Madison

Post Doc. Fellow, with Prof. Richard K. Olsen, Chemistry Dept. - Utah State University, Logan, UT

PROFESSIONAL DEVELOPMENT

Lean Six Sigma training, Life Cycle Management (LCM) training, cGMP, Validation, and FDA regulations

Managing People, Time Management, Negotiation and Conflict Management, Team Management

Software Skills: Microsoft Project, Chemdraw, Excel, PowerPoint, Isis, Visio, CARD (for DOE), SciFinder, Micro-

patent, and Thomson Reuters.

Contact this candidate