Supply Chain Management

JOHN A. WALKER, PHD

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

Minneapolis, MN 55419

612-***-**** (home phone)

763-***-**** (work phone)

763-***-**** (cell phone)

abidar@r.postjobfree.com

SUMMARY OF CAREER ACCOMPLISHMENTS:

Organizational Development - Initiated and lead a cross-functional program

within Medtronic Cardiac Rhythm Disease Management for addressing FDA

CDER pharma infrastructure of drug eluting cardiac leads. Started up and

served as inaugural Director of a Pfizer Planning & Scheduling Group to

integrate together Pfizer's R&D clinical supply chain activities and

optimize Pfizer's R&D internal manufacturing capacity.

People Leadership - 20 years of functional leadership experience. From

2006 to present, has led a set of cross-functional teams to bring FDA

CDER infrastructure (pharma) and CMC project execution to Medtronic

Cardiac Rhythm Disease Management. In 2005, initiated a global

clinical supplies planning group. From 2001 to 2004, served as Director

of a Pfizer research and development pilot plant. Responsibilities

included capital budget management, operating expense budget, management,

performance management, SOP administration, training, EHS, OSHA & GMP

compliance, incident investigations and Pfizer global career ladder

development.

Project Management - 20 years of experience with product development,

process development and technical transfer. Most notable achievements in

R&D pharma industry were introducing commercial scale processes for two

oncology products, CAMPTOSAR (irinotecan HCI injection) and Aromasin

(exemestane). Most notable accomplishments within medical device

industry were the IDE and PMA submissions and approval for the 4195

Attain StarFix and 4196 Attain Ability Cardiac Resynchronization Therapy

(CRT) steroid eluting cardiac leads.

Technical Process Development - 9 years of experience with leading a team

carrying out laboratory scale and pilot scale development of Active

Pharmaceutical Ingredient (API) processes. Designed and executed

experiments in both laboratory and pilot plant. Areas of expertise

include batch chemical processing, reaction monitoring, HPLC, GC, process

scale-up, Raman spectroscopy, crystallization, solid form

characterization, design of experiments, milling, GMPs technical report

writing and pharmaceutical process validation.

Technical Troubleshooting & Cost of Goods Reduction - 11 years of

experience with supporting approximately 50 different pharmaceutical

processes for technical support and cost of goods reduction.

Academic Partnering - Served as Adjunct Professor of Chemical Engineering

at Michigan State University, serves on Anoka Technical College Board of

Advisors.

PROFESSIONAL EXPERIENCE

Medtronic Cardiac Rhythm Disease Management

Senior Engineering Manager, Combination Device/Drug Therapy, Process and

Compliance

January 2006 to Present

Initiated and lead a series of cross-functional teams to bring FDA

pharmaceutical compliance to Medtronic Cardiac Rhythm Disease Management.

Specific applications include cardiac pacing and defibrillation leads

that deliver both electrical and drug therapies.

Functional leadership of a team providing document management, quality

systems, audit, CAPA and training to CRDM Therapy Delivery Systems.

Started a Medtronic Technical Forum across all Medtronic Business Units

to build collaboration in the area of combination device-drug products

across all Medtronic. Chaired in 2007 and 2008 the Annual Medtronic

Drugs, Biologics and Combination Products Symposia.

Medtronic Cardiac Rhythm Disease Management

4195 Attain StarFix and 4196 Attain Ability Interim Core Team Leader

September 2008 to January 2009 (Concurrent with Medtronic Senior

Engineering Manager role)

Core team leadership of the 4195 Attain StarFix and 4196 Attain Ability

CRT lead program teams. Key accomplishments were: US launch of the 4195

Attain StarFix lead, PMA-Supplement approval, product shelf-life

extension and closure of PMA conditions of approval. Successfully led

team through completion of all late-stage 4196 Attain Ability PMA issues

and preparation for US product launch.

Pfizer Glob al Research and Development

Director of Clinical Supply Chain Planning & Scheduling

January 2005 to December 2005 Pfizer Inc., Pfizer Global Research and

Development

(concurrent with leadership of Pilot Plant Operations)

Initiated and led a planning & scheduling group responsible for Pfizer

clinical supply chain resource management. Scope of responsibilities

includes scheduling raw material acquisition, analytical testing,

disposition, active pharmaceutical ingredient synthesis, drug product

formulation and clinical packaging. Responsible for collecting

operational metrics and capacity utilization across the supply chain.

Implemented a global scheduling database to fully integrate and optimize

across the multiple functional lines and sites of Pfizer Global Research

and Development.

Pfizer Glob al Research and Development

Director of Pilot Plant Operations

July, 2001 to April, 2003 Pharmacia Corporation

April, 2003 to January 2005 Pfizer Inc., Pfizer Global Research and

Development

Kalamazoo, Michigan

Led a pilot plant facility and organization responsible for supplying pre-

clinical, clinical materials in support of Pfizer research and

development pipeline and commercial product launch. The pilot plant

organization consisted of multiple operational shifts, an engineering

group responsible for both capital projects and maintenance and a

materials management group. Managerial responsibilities included direct

supervision of the personnel within the group, management of capital and

expense budgets, recruiting, personnel development, and salary

administration. Additional responsibilities included project management,

equipment installation, equipment validation, SOP administration and

compliance with all applicable environmental, health, safety and FDA

regulations.

Adjunct Professor of Chemical Engineering, 2001 to 2004

Michigan State University (concurrent with Pharmacia / Pfizer roles)

Department of Chemical Engineering

East Lansing, Michigan

Served as a research advisor for PhD graduate students. The faculty

appointment came from having mentored several Michigan State University

graduate students in industrial research projects at Pharmacia from 1994

through 2002.

Senior Research Scientist, 2001

Pharmacia Corporation

Chemical Process Research and Development

Kalamazoo, Michigan

Directed laboratory scale development, process safety assessment, pilot

scale development, technology transfer to commercial production area and

technical support of active pharmaceutical ingredients (API) and fine

chemical processes. Coordinated both technical leadership and project

management. Provided global technical support of sterile API and

particle size reduction processes. Partnered with QA, regulatory,

marketing and production units. Developed chemical and physical

analytical assays. Conducted cost of goods and capital scope estimates.

Provided process validation and documentation for FDA approval for API

processes. Unit operations in process development include chemical

reaction, liquid phase extraction, chromatography, crystallization,

filtration, drying and particle size reduction. Supervise chemical

laboratory staffed with technicians and a team of multi-shift pilot plant

operators.

Significant Achievements:

. Developed a process for a novel therapeutic class API for male and female

sexual dysfunction.

. Demonstrated an ethylene oxide free sterile micronization process for

injectable API.

Research Scientist, 1994 to 2000

Pharmacia & Upjohn

Chemical Process Research and Development

Kalamazoo, Michigan

Significant Achievements:

Developed a chemical/biochemical route to novel oncology product, Aromasin

(exemestane tablets) and obtained FDA approval in 2000.

Engineered development of 16-step synthesis of camptothecin derivative.

Developed crystallization expertise to control particle size distribution,

impurity incorporation and polymorphic (crystal lattice configuration)

forms in chemical intermediates and final products.

Applied continuous in-situ monitoring of crystalline polymorphic

transformation via Raman spectroscopy.

Scientist, 1992 to 1994

The Upjohn Company

Chemical Process Research and Development

Kalamazoo, Michigan

Significant Achievements:

4. Developed an environmentally benign steroid synthesis

5. Developed an oxidation process to shorten a steroid synthesis

6. Developed a model to predict drying times of production scale

processes from laboratory scale data.

Senior Staff Engineer, 1990 to 1992

Merck and Co., Inc., Technical Operations, Merck Chemical Manufacturing

Division

Albany, Georgia

Responsible for laboratory scale evaluation of improvement to existing

chemical processes and implementation to production. Managed technology

transfer of developed chemical processes from central research and

development facilities in Rahway, New Jersey to Albany, Georgia.

Significant Achievements:

Selected and developed an alternate solvent process in for the Cefoxitin

antibiotic process.

8. Designed and implemented a regional emission control system to reduce

methylene chloride emissions. Upon implementation, reduced emissions of

methylene chloride by over 1 million pounds annually.

Research Assistant and Teaching Assistant, 1985 to 1990

Purdue University, School of Chemical Engineering

West Lafayette, Indiana

Research Advisor Ronald P. Andres

Primary research included static and dynamic evaluation of performance

and integrated systems control of complex distillation networks. Served

as a teaching assistant and laboratory instructor for senior

undergraduate process control courses.

Pilot Plant Operator, Summers of 1984 and 1985

United Oil Products (A division of Allied-Signal)

McCook, Illinois

Collected pilot plant data for scale-up and design of oil refining and

sugar separation production facilities. Separated via distillation

chemical monomers for downstream processing. Conducted SORBEX (UOP

trademark technology) process applied to sugar separations.

EDUCATION

Doctor of Philosophy, Chemical Engineering Purdue University

August 1990 West Lafayette, Indiana

Master of Science, Chemical Engineering Purdue University

December 1987 West Lafayette, Indiana

Bachelor of Science, Chemical Engineering University of Notre Dame

May 1985 Notre Dame, Indiana

VOLUNTEER ACTIVITIES

Member of Anoka Technical College Advisory Council (2006 to present)

Leader of BioBusiness Alliance (Life Sciences Alley) Center of

Excellence on Convergence (2007)

Keywords - FDA CDER, combination therapy, steroid eluting cardiac lead,

research, development, R&D, technology transfer, project management,

manufacturing, technical support, troubleshooting, people leadership,

people management, GMP, good manufacturing practices, supply chain, cost

center, operating expense budget, capital budget, capital expense, facility

planning, resource planning, lean manufacturing, six sigma, engineering,

team, cross-matrixed, scheduling, planning, management, direct reports

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