JOHN TIERNEY

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

Monmouth Junction,NJ 08852

aca7zr@r.postjobfree.com

732-***-****

Executive summary:

Serious minded multi-disciplined executive with 25+ years of experience seeking challenging role.

Extensive knowledge of quality/analytical laboratory operations, R&D, and contract manufacturing.

Core strengths:

Champion and implement change that supports continuous quality improvement.

Promote teamwork, trust, ownership, and creativity.

Balance strategic objectives with operational capabilities.

Leverage resources and processes to enable employees to realize their full potential.

Optimize asset reliability, utilization, and sustainability with aggressive cost control.

Experience summary:

Consultant

Bristol Works LLC - 11/2013 - Present

Project Executive - Economic Project Solutions Inc.

Manufacturing Specialist; site development, equipment / instrument installation and qualification,

process development and validation, analytical method development and validation.

Director of Global Quality Affairs

NeoStrata Company, Inc. - 3/2010 – 11/2013

Ensure compliance with regulations, procedures, and corporate policy. Provide input to company

direction and P&L. Turnkey business model overseeing external CMOs. Responsible for method

development, validation, analytical release, commercial stability, upstream site compliance, and tech

transfer. 500 + SKUS of OTC and consumer products for both domestic and international distribution.

Direct oversight of process development, qualification, and validation. Release, quarantine, and

disposition decisions. Investigation/deviation and CAPA.

General Manager/Technical Liaison/Point of Contact

IGI Laboratories Inc. - 10/ 2007 - 3/2010

Direct oversight of compounding, packaging, warehousing, and facility maintenance. Initiated and

executed CapX upgrades to air and water quality. Re engineered compounding suites and packaging

floors. Managed contractors and bid packages. Contact for local, state, and federal agencies.

Developed validation matrix for equipment used in the production of topical, liquid oral, and nasal

OTC products. Selected, purchased, installed, and qualified OTC packaging line. Responsible for the

efficiency of manufacturing vessels and packaging lines. Accountable for plant scheduling and

budgets.

Consultant

Bristol Works LLC - 4/ 2002 - 9/ 2007

Provided guidance to others for supply chain, manufacturing efficiency, process and product

development, cost improvement formulations, analytical and efficacy test results. Provided QA/QC

oversight for contract manufacturers. Established a contract packaging facility.

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Director Operations

Aloe Creme Labs Inc. - 6/ 2000- 4/ 2002

Provided technical expertise for development and scale-up of FDA regulated consumer products.

Liaison for FDA and local government agencies. Doubled sales first year by increasing focus on

distribution, cycle times, and facility consolidations.

Business Partner

Plum Scientific Inc. - 6/ 1997- 6/ 2000

Established an analytical and finished product testing laboratory. Conceived and developed customer

base. Provided CMO release of product produced for Gryphon Development, BBW, Victoria Secrets,

and Cosrich.

Director of Manufacturing

Medicia Pharmaceutical Inc. - 8/1995- 6/1997

Responsible for department efficiency, product introduction, and technology transfer. Customer

liaison, equipment procurement, facility maintenance, raw material purchasing, budgets, and staffing.

Director of Manufacturing and Quality Control

Guest Packaging Inc. - 2/1992- 8/1995

Responsibility for directing scale-up technology and quality systems for 3 shift operation.

Introduced and validated hot reverse osmosis water treatment system. Validated $12 million CapX

processing suite equipped with bilingual computerized touch pad controls. Liaison for local, state,

and federal authorities. Designed manufacturing model to reduce manpower waste and increase

batching efficiencies 40%.

Spearheaded aggressive technology transfer to convert imported bulk product purchased to in-house

manufacture. Maximized efficiency by designing heat exchange system to reduce batching times from

72 hours to 8.

Quality Control Lab Manager (Bulk, Finished Goods, Analytical)

Revlon Inc. - 5/1982- 2/1992

Full recruiting and training responsibilities for technical staff of 25. Managed evaluation and

disposition of 4000 product and 8000 raw material SKUs. One of 3 FDA liaisons.

Integrated and validated manufacturing and quality systems for numerous multimillion dollar

acquisitions. Consolidated facilities and equipment.

Streamlined continuous batching technology to satisfy high speed filling lines. Provided organizational

leadership and optimized 24/7 systems.

Education:

BS Biology - Delaware Valley College, Doylestown PA

Masters Courses Chemistry - Fairleigh Dickinson University

SPC Training - Proctor & Gamble Boiler Black Seal Certificate

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