BHALCHANDRA H. PATWARDHAN, Ph.D.

***** **** ***** ****** ***-

***-**** (Mobile)

Leawood, KS 66224 abmx3u@r.postjobfree.com

913-***-**** (Residence)

PROFILE

A successful, results oriented executive always seeking newer and greater

challenges in Quality Assurance and Regulatory Affairs. A resourceful,

strategic and analytical thinker with strong executive presence, an

acknowledged leader, change agent and trouble-shooter with a proven track

record in pharmaceuticals, bulk pharmaceuticals, biological products,

vaccines, medical devices, animal health products and food ingredients.

Core Competencies:

> Strong scientific/technical background

> Extensive knowledge of GMP, GLP, GCP and ISO 9002,13485, broad

experience in

regulatory strategies leading to approval and ongoing

compliance management of products

> Extensive regulatory experience with FDA (CBER, CDER,CDRH), USDA, DEA,

EU, EPA, OSHA and other domestic and international pharmaceutical,

consumer health and animal health regulatory agencies

> Extensive global (EU, Asia/Pac-China, Taiwan, Australia, Latin and

South America) and multi-plant experience (10 facilities worldwide)

> Enhanced skills related to process development, technology transfer,

manufacturing, plant

trouble shooting and technical services

> Demonstrated leadership skills and ability to influence team members

with diverse backgrounds and objectives

> Ability to work in a highly collaborative environment and support

others to create breakthrough solutions

> Received nine process patents

PROFESSIONAL EXPERIENCE

FORT DODGE ANIMAL HEALTH, Division of Wyeth Inc. - Overland Park, KS

2008 - 2010

Animal Health - Biologicals and Pharmaceuticals, Sales: $1B, 3000

employees, 10 Plants worldwide

Vice President -Global Quality Assurance

Accountable for quality assurance for all manufacturing plants in

accordance with regulatory requirements and regulations, both domestic and

international. Responsible for building quality directly into process and

products manufactured for commercial use.

. Developed and strengthened partnership between Quality and Manufacturing

at all levels of the organization

. Significantly improved the perception and interaction between FDA and

Fort Dodge Animal Health

. Encouraged a strong team oriented culture with minimization of functional

silos

. Implemented " QA on the Floor" .During recent FDA inspection, this

initiative was highly commended by the inspectors

. Hosted Regulatory inspections that resulted in no critical observations

. Improved batch record quality and exceeded target of 80% "first time

right" batch records

. Reduced Recall/Stop Sale/Field Alert instances worldwide.

. No Recall/Stop Sale/Field Alert for US sites in 2008

. Commended for: improving competency of Quality Assurance department,

building partnerships both within and outside the organization, and

being ethical and decisive

BHALCHANDRA H. PATWARDHAN, Ph.D. PAGE 2

LIFE THERAPEUTICS - Clarkston, GA

2005 - 2008 Products: IVD test kits, Normal source and

Hyperimmune plasma collection in 14 centers across US, Sales: $130M, 500

employees, worldwide market

Executive Vice President - Quality/ Regulatory Affairs

Provided strategic leadership and direction to Life Therapeutics.

Responsible for Quality Assurance/

Regulatory Affairs for Life Sera (collects hyperimmune and normal source

plasma) and Life Diagnostics (manufactures IVD test kits (510-K & CE

mark)). Responsible for GCP compliance for pre-clinical and clinical

development of new drug substances and immunization of donors to generate

antibodies to anthrax, smallpox, rabies and tetanus.

. Managed 40 professionals including Vice President and Directors

. Partnered with stake holders to ensure that coherent quality and

regulatory strategies are implemented to achieve sustainability for Life

Therapeutics products

. Provided exemplary leadership and fostered a collaborative atmosphere for

integration after acquisition of five new plasma collection centers

. Received no critical or major observations in 50 regulatory audits (FDA,

EMEA and GHA) over two years

WYETH VACCINES - Pearl River, NY

2004 - 2005

Products-Vaccines, Sales: $1B, 2500 employees, world-wide market

Director, Quality Assurance

Accountable for quality assurance of bulk formulation and release of

'Prevnar', a vaccine with sales of $1B. Responsible for Computer

Validations, QMS compliance, discrepancy management, tracking and trending,

investigation, resolution, material review board, CAPA, audit commitment

follow up.

. Supervised 40 managers and QA associates

. Took over when division was under consent decree and successfully

managed quality functions

. Improved employee participation and morale

. Released a record number of vaccine lots in six months

BAYER CORPORATION

1982 - 2004

Manager - Director, Quality Assurance - Biological Products, Clayton, NC

(2002 - 2004)

Products- Plasma proteins (immunoglobulins, anti-hemophiliac factor etc.),

Sales: $1B, 1200 employees, world-wide market. Accountable for GMP GLP,

GCP compliance during the clinical trials of Alpha 1-Proteinase Inhibitor

and a thrombolytic agent. Responsible for approval of validation

protocols, batch production records, critical change controls and review &

disposition of discrepancies, computer Validations, Part 11 compliance,

contract review, internal and external audits (vendors, CMO, CRO).

Responsible for quality assurance in utilities, computer validation, SAP,

labeling and material clearance.

. Supervisory responsibility for 10 professionals including managers and

quality associates.

. Executed a critical role providing guidance in the design of a new cGMP

manufacturing facility, which was approved by the FDA without any

changes.

. Successfully shepherded three new products from concept through

toxicological studies, manufacture of Clinical product and submission of

IND.

Staff Scientist, T/O Support - Biological Products, Clayton, NC (2001 -

2002)

Accountable for providing technical support to purification, dissolving and

filtration, sterile filling & packaging. Responsible for process

troubleshooting, process development, discrepancy investigations,

preparation and execution of validation protocols. Supervised 8

professionals.

. Developed an understanding of processes, purification and sterile filling

facilities which served as a.

basis for success in managing quality assurance

BHALCHANDRA H. PATWARDHAN, Ph.D. PAGE 3

Senior Research Scientist - Animal Health, Shawnee, KS (1998 - 2001)

Products - Animal vaccines and antibiotics, Sales: $800M, 3000 employees,

world-wide market. Accountable for the manufacture of clinical lots of

hyaluronic acid with GMP, GLP and GCP compliance. Responsible for animal

vaccines manufacture, process troubleshooting, optimization of fermentation

processes. Supervised 6 professionals.

. Key member of project responsible for installation, startup, validation

and troubleshooting of a

Hyaluronic acid plant. Plant was approved by FDA in a record time of

six months.

Director, Process Development/Quality Assurance - Biotechnology, Elkhart,

IN (1996 - 1998)

Products - Food ingredients, Bulk Pharmaceuticals, Sales: $ 300M, 2000

employees, world-wide market

Accountable for Quality Assurance & ISO 9002 coordination for division

manufacturing bulk pharmaceuticals in seven plants worldwide. Responsible

for process development, process optimization, scale-up, technology

transfer and plant troubleshooting for the division.

. Supervised group of 100 QA professionals including directors and

managers in 7 plants worldwide

. Instituted rigorous action limits for final product rejection reducing

annual customer complaints by 60% in the first year

. Coordinated divisional GMP compliance and divisional ISO 9002 compliance

resulting in excellent audit reports

. Responsible for process development in seven plants worldwide

Director, Process Development, Biotechnology, Elkhart, IN (1989 - 1996)

Accountable for process development in seven plants worldwide. Responsible

for process development, process optimization, scale-up, technology

transfer and plant troubleshooting and worldwide responsibility.

. Supervised of a multi-disciplinary group of 60 professionals in seven

plants worldwide

. Developed a new process for spray granulation of citric acid and

sodium citrate (received 4 patents)

. Developed new mutants for citric acid fermentation with significant

higher yield.

. Conceptualized and developed an innovative process for purification of

citric acid and sodium citrate from fermenter broth (received 3 patents).

. Developed new product formulation for detergents in collaboration with

Proctor and Gamble and Kool-Aid in collaboration with Kraft Inc.

(received 2 patents)

Research Scientist - Manager, Process Recovery, Biotechnology, Elkhart, IN

(1982 - 1989)

Team leader responsible for installation, startup and troubleshooting of

48,000,000 pounds per year Trisodium Citrate plant in Elkhart.

EDUCATION/PROFESSIONAL DEVELOPMENT

Ph.D. Organic Chemistry - Nagpur University, Nagpur, India

Thesis: "Studies in Reaction Mechanisms: Stobbe and Related Reactions"

M.Sc. Chemistry - Nagpur University, Nagpur, India

Specialization: Organic Chemistry

B.Sc. Physics, Chemistry, Mathematics - Nagpur University, Nagpur, India

Bayer/Notre Dame Executive MBA Program

RAB certified lead auditor for ISO 9000

Published 27 papers in international journals (list available on request)

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