V. Jeff Johnson

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

Wendell, N.C. 27591

919-***-**** (h)

252-***-**** (c)

k8givd@r.postjobfree.com

Career Summary:

An experienced technical and organizational leader in pharmaceutical manufacturing operations, providing clinical and commercial supply for most dosage forms. Well-rounded in business with several start-ups. A demonstrated performer in affecting change for improvement in compliance and bottom line initiatives. Known for a solid work ethic and incessant drive to win. I uniquely combine technical expertise with the human element for my firm’s profitability, compliance and longevity.

Work History:

Plant Manager – NBTY Incorporated, Wilson, NC (10/09 – Present) - Span of control encompasses all business functions undertaken at the site. Solid dosage operations include dispensing, blending, granulation, compression, encapsulation, coating, warehousing and distribution. Currently expanding the 24x7 operation in capacity and capability.

North Carolina Director of Manufacturing Operations and Technical Services – Catalent Pharma Solutions, RTP and Raleigh, NC (07-09) – Multi Site Responsibility for Contract Clinical and Commercial Supply for all Injectable, Pulmonary and Nasal Products. Dosage forms include Aseptically Filled Liquids, Lyophilized Vials, Pre-Filled Syringes, Metered Dose Inhalers, Dry Powder Inhalers, Nasal and Sub-Lingual Sprays. Direct oversight for operations, technical services, technical transfer, materials management as well as lean systems integration. Responsible for design, construction and validation of production facilities and equipment to accommodate new technologies. Successfully remediated FDA warning letter at N. Raleigh site within 14 months of issuance to prior management team. Primary host for FDA audit.

Director of Operations and Technical Services – Catalent Pharma Solutions, RTP, NC (05-07) – Responsible for the Contract Clinical Supply Business for Pulmonary and Nasal Products including MDI’s, DPI’s, Nasal and Sub-Lingual Sprays. Site-wide Technical Services Director responsible for Stability, Stability Engineering, Validation, Engineering, Metrology, Sample Coordination, Materials Management, Purchasing, Environmental Health Services and Site Maintenance. Site Champion for Lean Systems for Management Implementation.

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Engineering Consultant – Glaxo Smith Kline, (04-05) Key planner for $ 92 million expansion for solid dose renovation. Assisted in determining facility layout, equipment requirements, and staffing requirements. Utilized Arena Simulation software for optimal capacity and efficiency determinations.

Site Manufacturing Manager – Glaxo Smith Kline, (2/03 – 12/04) Responsible for all site manufacturing of Solid Dose and Metered Dose Inhalers. Managed over 185 staff spread over various shift structures producing 67 sku’s with a $14 million budget. Implemented Lean Six Sigma. Successfully endured several audits from the FDA, MCA, Saudi Arabia and customers resulting in 0 critical or major observations. Conducted reorganization of departmental staff.

Solid Dose Manufacturing Manager – Glaxo Smith Kline, (5/02 -2/03) Responsible for all aspects of cGMP compliant production of 2 billion tablets per year across 42 sku’s. A 24x7 operation employing 142 staff, 7 supervisors and 14 process leaders, and a $10 million budget. Processes include dispensing/blending, granulation, compression, coating, printing and encapsulation /banding. Inherited an area with demands greater than capacity. However, increased output by 25%, while reducing deviations in bottleneck areas within 2 months of assignment.

Aerosol /Vial Packaging Manager – Glaxo Smith Kline, (5/01 – 4/02)

Managed a 24x6 operation packaging Metered Dose Inhalers, Injectables, and Vials, utilizing 172 head, over 5 packaging lines on a $7 million budget. Managed through a demand downturn, requiring headcount cutbacks, while reducing unit cost and deviations simultaneously.

Industrial Engineering Section Head – Glaxo Wellcome, (3/99 -4/01)

Re-established IE department after post merger disintegration, including recruitment and assignment of 9 degreed IE’s. Implemented MRPII processes sitewide to ultimately achieve Class A Certification.

Principle Industrial Engineer – Glaxo Wellcome, (4/97 – 3/99)

Site IE responsible for all value streams. Established and maintained standards, wrote project justifications and identified CI opportunities.

Product Transfer Manager – Glaxo Wellcome, (2/95 – 3/97)

Led cross functional team to transfer product from UK to USA, including oversight of stability batch production and testing, methods development, sNDA submission, and process validation. Project completed 2 months ahead of schedule and under budget.

Senior Industrial Engineer – Glaxo Inc., (2/92 – 2/95)

As a merger IE, identified process capabilities and capacities of various pharmaceutical firms throughout N. America. Data assimilated into an easily accessible matrix allowing for scenario development and decision capability.

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Glaxo Pharmaceutical Sales Representative – Glaxo Inc. (1/94 – 7/94)

A professional development assignment, trained on the detailing of Zantac, Ceftin and Serevent. Maintained St. Petersburg territory for 6 months, driving an increase in scripts for all products of responsibility.

Industrial Engineer – Glaxo Inc., (2/89 – 2/92)

Traditional IE performing time studies, feasibility studies, and simulation of production in various departments.

Quality Engineer – Michelin Tire Corporation, (7/87 – 2/89)

Responsible for all aspects of Quality Assurance for tire fabrication including documentation, calibration, IPC’s, SPC implementation, trend analysis as well as internal/external audit hosting.

Team Manager – Procter and Gamble – (5/85 -7/87)

Supervised liquid filling operations (5 lines) and batch sulfation department. Transitioned to Team Based Organization while amending labor union contract.

Education:

BS Industrial Engineering – North Carolina State University, 1985

High School Diploma, Clayton High School, 1981

Certifications:

ASQC Certified Quality Engineer, 1989

FAA Certified Private Pilot, 2001

References are available upon request

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