Post Job Free
Sign in

COO / VP / Senior director of operations. cGMP especially

Location:
Miami, FL
Salary:
at least $125,000
Posted:
September 17, 2014

Contact this candidate

Resume:

JOHN COLLAR

Mobile: 303-***-**** Email: ****.******@*****.***

I have led teams in small, medium-sized, public, non-profit, and

Fortune 100 corporations through processes to resolve complex business

challenges, transforming business performance through Project

Management, Business Analysis, Lean Process / Continuous Improvement,

Engineering, Quality, R&D, Procurement / Distribution / Supply Chain /

Logistics, Operations Management, Innovation, and Change Management

methodologies.

I have served in progressively responsible, functional roles spanning

from entry level packaging engineering through CEO and Co-Founder,

both domestically and internationally. I am a passionate operational

executive leader, delivering world-class performance through the

application of lean tool sets with innovative solutions. While

specializing in FDA regulated industries, my skills have demonstrably

brought material results to other industries as well.

Expert level skills summary:

Optimize quality, service, and costs

Methods Human Resources

__\ \

/ /

Materials Processes

o Operations management from product development through

production planning / supply chain management, procurement &

inventory management, manufacturing / packaging,

warehousing, customer service and distribution logistics,

along with all related infrastructural functions. Includes

complex negotiations and contractual agreements.

o Quality Systems - thorough working knowledge of quality

systems: ISO, FDA cGMP, & cGLP. Creation of SOPs, auditing,

and company representation.

o R&D - concepts through scale up, engineering, production

systems, V&V

o M&A evaluations - served on operations and quality assessment

M&A teams for Baxter, including International assignments in

Europe, Mediterranean, Africa, and South America.

o Optimizes quality, service, and costs - corporate Lean

enterprise champion, training facilitator, steering committee

leader. Applied lean tools and techniques to real life

opportunities resulting in optimal solutions.

o Builds highly effective, cross functional teams - through KPI

driven approaches tied directly to the Corporate Mission,

Strategies, and Tactics.

o Expert in strategic planning, deployment, and management

through key metrics.

o Standalone P&L and balance sheet experience, along with

budgetary & complex planning responsibilities.

o International & domestic track record spanning start-up

through Fortune 50 organizations such as Baxter, Corning

Medical, and Schering Plough.

o Demonstrated track record of conceptualizing, justifying,

building, implementing facilities and organizations in a wide

diversity of industries, cultures, and geographical

locations.

o BS in Packaging Engineering from Michigan State University,

MBA from Barry University, Miami, FL., Professional

Certifications - packaging and materials management

o Extensive network built through leadership of a bioscience

trade association, investors conference, plus state &

regional industry growth initiatives.

o Served on multiple Boards of Directors, including

chairmanship of a non-profit organization.

Colorado Management Systems - founded 10/2006 to current.

Managing Director / President: Performed executive level

operational / management & hands on consulting services: Examples:

Matrilinex LLC, Sterling Biotech, NeuroMark Inc, Covidien,

UrgentRx, & Amrion Nutraceuticals.

. Served as Chief Operating Officer & VP of Operations of OTC &

biotech companies: Responsible for building all daily

operations and administration of early stage biotech firms.

cGMP, ISO, CLIA, and CFR compliant.

. QSR: Covidien Respiratory Care: reviewed, developed and

completed complex FDA 483 response documentation packages.

UrgentRx 5/13 - 2/2014 Vice President of Operations

. Created & built the operational infrastructure including an

FDA auditable quality system, along with the implementation

of ERP, contract manufacturers, a 3PL provider, an R&D

product development system, human resources function, and

field services.

o Developed products, scaled manufacturing & distribution,

which has grew from 2,100 retail outlets in June 2013 to

over 24,000 in March of 2014. Developed & implemented

Quality Systems, including third party CMO's & vendors.

o Drove & coordinated the first ever strategic plan in

July 2013

Amrion Nutraceuticals 5/10 - 5/2013 CEO /COO

. Co-founded and responsible for conception, developing, and

implementing all day to day functions of a top quality

nutraceutical company built to cGMP standards.

o Developed and implemented corporate policies and all

quality systems

o Created vendor management & qualification systems.

Identified, validated, and brought on line contracted

resources for manufacturing, customer contact center,

and distribution operations. Implemented in house call

center & distribution operations. Oversaw IT & website

systems development.

o Coordinated R&D formulation development and subsequent

manufacturing of products

Colorado BioScience Assoc 11/2008 - 5/2010 President & CEO

. Developed & implemented a state wide strategic plan for

growing the bioscience industry. Worked closely with state &

federal legislative representatives to create and pass

industry favoring legislation. Implemented regional

initiatives through educational, membership, public policy,

facilities, and board level committees representing over

120,000 state wide employees

. Board of Directors member as well as founding board member of

the Colorado Institute for Drug, Device, and Diagnostic

Development

. Won community leadership award from North Metro Chamber of

Commerce

Octagon Systems Corp 2/2003 - 9/2006

VP of Business Development / Operations & Member of Board of

Directors

. Achieved best ever metrics of 99.4 % on time delivery while

growing company 16% annually while earning ISO 9000

certification. Obtained economic incentive packages from

state & local governments.

. Key team leader in obtaining major new business contracts in

domestic & global markets, through stock and custom developed

products.

Industrial Laboratories Company 7/2000 - 1/2003

President & VP of Operations - responsible for all activities of a

privately held, contract analytical laboratory services

organization operating under FDA cGMP, GLP & ISO guidelines.

. Applied theory of constraints models to restructure

organization. Lowered operational costs by 19%. Reduced

average project cycle time from 11 days to 4.5, improved on

time measures from 60% to over 90%

. Aggressively pursued & accomplished acquisitions,

divestitures, joint ventures, and recapitalization.

Whole Foods Markets Inc / WholePeople.com 12/1997 - 7/2000

Director of Operations - responsible for all planning, purchasing,

new product development, manufacturing & distribution related

activities in a stand-alone business unit with P&L responsibility.

. Concurrently designed, built, and implemented all cGMP

manufacturing and distribution operations within a 405,000

sq. ft facility while running existing ops.

. Won President's award for Excellence in Leadership in 1998.

Served on Corporate wide strategic planning team.

Warren Distribution Corp 11/1995 - 12/1997

Vice President Manufacturing & General Manager - focused on

business improvements by defining, developing, & implementing

business solutions for a very large manufacturing plant.

. Earned ISO 9001 certification in less than one year, turned

around customer satisfaction, inventory, and regulatory

performance issues through TPS tools & house of quality.

Baxter 1983 - 1995

International Director of Operations - performed international

operations management, new product introductions, and inventory

management involving 85 countries & over 100,000 healthcare product

skus. Included the evaluation, recommendations, and implementations

of acquired Companies throughout European, Mediterranean, Northern

Africa, Caribbean, and South American regions.

. Supported 20 -26 % annual international market growth. Directed the

procurement & management of $ 7 million of on hand inventories in

remote locations with turns greater than 18. Managed diverse

logistical systems. Developed & implemented export control systems.

. Prior to becoming Director of their international operations, I

served as Operations Manager, Quality Manager and Manufacturing

Engineer for Baxter's Dade Diagnostic division.

Schering Plough, Miami Florida 1987 -1990

Senior Research Engineer - development, redesign, & technical

support of novel transdermal & oral drug delivery systems. Managed

controlled substances inventories, contractual development and

manufacturing initiatives. Prepared FDA submission sections for

materials & manufacturing. Developed, staffed, and implemented a

state of the art materials lab valued at $2M. Reduced cycle times

by 25%.

Corning Medical & Scientific Division 1979 - 1983

Packaging engineer, Senior Industrial Engineer, Process systems

Supervisor

CREDENTIALS

. Master's of Business Administration, Barry University, Miami Florida

. Bachelor's of Science in Packaging Engineering, Michigan State University

. Certified Professional: Packaging Engineering, Materials Handling, &

Materials Management

. Continued educational course work - six sigma quality engineering &

technologies, auditing, import / export regulations, and materials

management. Management courses in: Shingo & CFM technologies, project

management, TPM, Finance, and operations management.

. Professional Associations & Board of Director's - Colorado Association of

Manufacturing & Technology: Chairman of the Board, CID4, Butterfly

Pavilion, Westminster Economic Development, MSU alumni association,

Society of Packaging & Handling Engineers, American Society of Quality,

Aircraft Owners & Pilots association. Served as National Chairman of

Professional Certification for SPHE / IoPP

. Licenses - FAA private pilot, multi-engine rated, USCG 50 ton captain's

license with a master's endorsement

Key words:

Board of Director Chairman Board Member committee chairperson governance

finance strategic plan planning deployment mergers & acquisitions,

metrics international lean operations manufacturing engineering

packaging professional certifications materials supply chain IT systems

bachelors of science degree MBA Masters of Business Administration

marketing start up turn around fortune 50 medical device diagnostics

pharmaceuticals nutritional supplements nutraceuticals dietary

supplements not for profit for profit public private audit quality world

class ISO CE CFR FDA FTC NDA NDI



Contact this candidate