ANDY HOOPER

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

858-***-**** (home)

San Diego, CA 92128

858-***-**** (cell)

accnn0@r.postjobfree.com

http://www.linkedin.com/in/arhooper

PROFILE: Pharmaceutical manufacturing operations leader and consultant with

25+ years of experience in leading complex manufacturing and

technical services operations across multiple sites, strategy

development, business excellence and business process

reengineering, global technology transfers from R&D and site to

site, new site location studies, project management and product

launches. Demonstrated leadership in delivering business results

in start-up, growth, decline and turnaround situations.

Multi-cultural change agent with multiple lean six sigma and other

project successes across a large global site network.

PROFESSIONAL

EXPERIENCE:

Consultant and Managing Consultant

Jan., 2008 - present

Subcontractor: PMO development and management of project teams for

a Tunnell Consulting, Inc. client (6 month contract, 2013)

Managing Consultant for Tunnell Consulting, Inc. (Feb., 2011-Feb.,

2012):

Contributed to development of a Technology Transfer service

offering

Lean Six Sigma: Process Capability and Control assignment

Project management for US government agency funded bio-defense

"next generation" vaccine development programs: management of

prime contract, tech transfer and CRO/CMO subcontractors (2012 -

2013)

Proposal development: responses to government agency solicitations

(2012)

Business development for two full service CDMOs (2009 - 2011)

CDMO Logistics department reorganization and inventory control

software implementation (2008)

CMC support: sale of Balboa Bio's intellectual property after

closure (2008)

Balboa Biosciences, Inc., La Jolla, CA, Vice President,

Manufacturing & Technical Services, Dec., 2006 - Dec., 2007

2006-2008

Start-up and leadership of all CMC due diligence, development,

supply chain and related CDMO API and DP sourcing and development

activities

NCE/Drug Product Technology Transfers

Added significant IP value by achieving API and drug product

development project milestones ahead of schedule and cleaner

synthetic pathways

Qualis, Inc., Des Moines, IA, Director of Operations

2005-2006

Responsible for device and drug product processing, packaging

validation, maintenance, EH&S, facilities, warehousing and

distribution

Hired to improve operations and infrastructure after the company

received an FDA warning letter - successful remediation

Site subsequently closed; major product lines sold to Perrigo

Sanofi legacy companies: Aventis, Hoechst Marion Roussel, Marion &

Co.(PR), Marion Merrell Dow and Merrell Dow, Canada

Director of Industrial Technology, North America

2001-2004

Led new product technology transfer, scale-up, validation, new

package development and site to site transfers, for

Sanofi-Aventis, North America

N.A. Industrial Operations multi-site regional management team

member

Interim VP

Project Management Trainer to Engineering and Tech Transfer Teams

International projects: Canada, PR, USA, Mexico, and European

sites

Completed a Global Industrial Operations Excellence project:

development, piloting and successful roll-out to 25 global

manufacturing sites

Web-based global site network strategic initiatives and key

performance indicators tracking system management

Post-merger integration projects

Achieved over $50,000,000 in savings through lean six sigma

initiatives

Successful warning letter remediation within 4 months at newly

acquired ex-Rhone-Poulenc Rorer (RPR) site

Successful and rapid product recall investigation including

remediation

North America Industrial Operations Technologies and Engineering

Center Leader, Aventis North America Headquarters, Kansas City, MO

1999-2001

Led transfer and scale-up of new products from Global R&D and site

to site/CMO transfers of existing products - solid dosage,

parenterals, powders

Technical Leader for on-site engineering and technical support

services to North America manufacturing sites for product and

process improvements

Trainer: Project Management, Lean, Tech

Transfer/Scale-up/Validation

Achieved 100% on time global product transfers, scale-up,

validation and launch quantity build, leading to immediate launch

readiness

Manufacturing Manager, Puerto Rico Operations

1992-1999

Reported to Marion & Co. Division President/GM as Manufacturing

Manager/Site Leadership Team member, through start-up, ramp-up and

plant closing in 1999, due to elimination of IRS Section 936 tax

benefits

Led staff of approximately 150 associates in a multi-shift

operation

Responsible for bulk manufacturing and finished product packaging

of key global strategic products (blockbusters): Seldane,

Cardizem, and Allegra

Prevented blockbuster product batch rejections and product recall

through continuous use of Statistical Process Control and root

cause determination

Extensive use of MBWA, value stream mapping, business process

flowcharting and re-engineering, to eliminate non-value added

activities and achieve improved efficiencies, cycle time reduction

and lower costs

Inspection readiness and results: no FDA observations to correct

Cycle time reduction: 80% reduction over two years, down to <7

days

Yield improvements to >99%, achieving >$11,000,000 savings

Customer service: 100% on time delivery to all distribution

centers

Energy conservation: chaired committee, reduced costs >$5,000,000

Net documented savings at site >$20,000,000

Manufacturing Supervisor, Packaging Supervisor,

Purchasing/Planning Supervisor, Systems Administrator, Richmond

Hill, ON, Canada

1985-1992

cGMP manufacturing operations serving the Canadian market with

Merrell Dow brands (Seldane, Novahistex, Nicorette and private

label generics

Promotions and lateral transfers through operations departments

with a focus on Manufacturing/Packaging/Ops management and capital

expansion

Trainer for: SPC, GMP, Safety, MRPII, MIR, Meeting Facilitation

Successful implementation of SMED (Single Minute Exchange of Dies)

and automation to achieve line changeovers in Packaging of <20

min, and automated Clean-In-Place systems for Liquids & Blending

departments to achieve Overall Equipment Efficiencies of greater

than 80%

EDUCATION:

Bachelor of Science (Biology), University of Western Ontario,

Canada

Continuing education: Finance, Accounting, Statistics, Project

Management

CERTIFICATES: Lean Six Sigma Black Belt, CPIM, Purchasing, SPC, Project

Management

A.R. Hooper LLC

[pic]

[pic]

Qualis, Inc.

[pic]

[pic]

[pic]

[pic]

Contact this candidate