Manager Engineer

B. Michael Lee

*** ******* ** ( Hamilton, NJ ****0

Phone: 609-***-**** Email: *********@*******.***

Profile

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Procurement ( Change Control ( Quality Assurance ( Systems Integration

Distribution ( Process Engineering ( Plant Operations ( P&L Responsibility

Recognized as an extensively experienced broad based executive showcasing

more than twenty years of proven ability in domestic and international,

manufacturing, purchasing, materials management, technology transfer,

equipment planning and systems development. Proactive and results driven,

a superb communicator who is unafraid to institute bold initiatives and

carry them out in order to effectuate positive change, efficiency and

increased profitability.

V Exhibits a wealth of experience as the Director of Pharmaceutical

Technology; offering a stellar record of accomplishments as an innovative

strategist.

V Incisive and influential: a visionary leader with excellent instincts and

a passion for getting results.

V A respected team champion who is successful in engaging and mobilizing

staff, capitalizing on individual strengths to inspire outstanding

performances.

V Valued business partner with a history of success in delivering cost

effective business solutions.

V Exceptional negotiator: creative and collaborative in approach.

Qualifications Summary

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Accomplishments in Plant Operations, Quality Control, Process Engineering,

Change Control, Production, Packaging and Bulk Compounding. Over twenty

years of experience, with a proven record of teambuilding, strategic

partnering, and long-term planning. Lead successful campaigns in a

corporate environment where growth and accountability are paramount. Key

competencies include:

( Capsule Filling ( Quality Control ( Strategic Alliances

( Equipment Startup ( Equipment Sizing ( Toner Manufacture

( Creams and Lotions ( Suppository Products ( Process

Development

( Tablet Manufacturing ( Operations Management ( Film and Sugar

Coating

( Cosmetics & Fragrances ( Supply Chain Management ( Project

Costing/Development

( Training New Union Personnel ( Hazardous Materials Shipment (

Standard Operating Procedures

( Good Manufacturing Procedures ( Technical and Proposal Writing (

Contract Negotiations & Closing

Career Synopsis

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CMIC-VPS Corporation, Cranbury, NJ

2006-Present

Product Development manager

My responsibilities include operations, maintenance, process scientists,

distribution and planning.

. Develop business process improvement for R&D reporting, customer /

vendor relationships, product development and manufacturing.

. Review and approve all Master Batch Records used for GMP Manufacturing.

. Draft, review and approve all R&D reports from manufacturing of R&D

Batches.

. All maintenance, calibrations and purchasing for the facility.

. Draft, review and approve all SOPs, Change Control Documents and

Deviations.

R sum of B. Michael Lee, 609-***-**** continued

Page 2.

King Pharmaceutical, Inc. Bristol, TN

2000-2005

DIRECTOR, PHARMACEUTICAL TECHNOLOGY

The Pharmaceutical Technology department includes the Metrology group, the

Manufacturing Equipment Preventive Maintenance and the Equipment Purchasing

group.

. The Metrology Department increased by 400% in number of calibrations

performed and reduced in half the number of out of tolerances reports.

. The department tripled from one to three metrologists the size of the

Department.

. Designed Preventive Maintenance work orders; providing feedback and

data for the use in investigations of equipment failures.

. Analyzed and approved all validation IQs, OQs and Process Validations

pertaining to Manufacturing and Packaging.

. Tech transfer of Products into the plant from Contract Manufacturing

site to include drafting of protocols and batch record processing.

. Revised equipment processes and increased batch size to reduce the

total number of batches needed. In one case we tripled from 100KG to

300KG the batch size and utilized existing equipment to full capacity.

. Team member for evaluation of new product acquisitions.

. Led plant investigations for failures in manufacturing or stability.

Provided Technical support to investigations as requested by contract

facilities.

. Managed the tech transfer of products for one contract manufacture to

another contract manufacture. Including batch record review for on

site supervision of experimental and validation batches.

. Served on the Change Control Committee to review and approve all

changes within the plant.

G&W Laboratories, South Plainfield, NJ

1999-2000

MANUFACTURING MANAGER

A generic company manufacturing suppositories creams and ointments.

. Third shift manufacturing and packaging manager.

. Responsible for all aspects of manufacturing including training,

batching, cleaning and personnel.

Lannett Company Inc. Philadelphia, PA

1997-1998

PRODUCTION MANAGER

A Generic Pharmaceutical Company

. Manager of manufacturing and packaging.

. Plant is operating at two shifts producing tablets and capsules.

Merck, Inc. Rahway, NJ

1995-1997

PROCESS ENGINEER

Process Engineer for the final phase of the TBZ (Thiabendazole) production.

. The process consists of a vacuum reactor, five columns, a

crystallizer, carbon columns, purifying, drying and packaging

operations.

. Responsibilities included the day-to-day operation of the process as

well as tracking all changes, safety assessments and abnormalities in

the process.

. Manufacturing production records were broken in the last six months of

operations, the most TBZ produced in any six month period in the 25

years of operation.

Whitehall-Robins, Hammonton, NJ

1991-1993

BULK MANAGER

Responsibilities included managing the bulk production department.

. Directed 110 - 120 hourly, clerical, and supervisory personnel.

. Reported to the assistant Plant Manager with responsibility for

Manufacturing Department and interfacing with the Accounting,

Maintenance, Packaging, Validation and Warehouse Departments.

R sum of B. Michael Lee, 609-***-**** continued

Page 3.

Whitehall-Robins, (continued)

BULK MANAGER

. Oversight responsibility with R&D on new and existing products.

. Designed and implemented GMP training for operations to increase the

compounders' ability to manufacture within guidelines.

. Managed the transfer of equipment and processes from the Elkhart plant

to the Hammonton plant, resulting in a smooth transfer to the new

facility.

. Maximized the Sugar coating process to achieve a record of 110%

production levels in 1992. Directed seven day a week three shift

operation in achieving this goal.

Whitehall-Robins, Elkhart IN.

1983-

1991

Responsibilities included managing 40 - 50 production employees, salaried

managers and clerical support staff.

. Reported to the Assistant Plant Manager with responsibility for

Manufacturing Department and interfacing with the Accounting,

Maintenance, Packaging, Validation and Warehouse Departments.

. Oversight responsibility with R&D for new and existing product.

. Directed the turnaround for increased production of capsules while

eliminating overtime.

. Coordinated the start up of new creams production equipment, which

tripled from 300LT to 1000LT manufacturing capabilities.

. Installed a film coating process and devised methods to ensure 100%

utilization of coating pans.

. Upgraded training/abilities of union mixers, which would disqualify

some staff; this was accomplished without union grievance.

Coty Division of Pfizer, Inc., Sanford, NC

1977-1983

COMPOUNDING MANAGER

. Reported to the Director of Operations with manufacturing

responsibility for Packaging, Planning, QA, and Accounting.

. Oversight responsibility with R&D on procedures for new and existing

products; maintained contacts with other divisions of Pfizer.

. Developed a cross-training program; increased flexibility necessary

for fluid scheduling and guaranteed production.

. Increased batch production 25% without adding manpower.

. Instituted a changeover program to reduce operational waste; procedure-

based losses decreased from $63,000 to 0.

Xerox Corp, Webster, NY

1973-1977

QA/PROCESS ENGINEER and PRODUCTION FOREMAN

. Worked in the Toner Manufacturing Plant as QA Engineer, Process

Engineer and Production Forman

United States Coast Guard (LTJG)

1970-1973

STAFF ENGINEER

As Staff Engineer in Hazardous Materials Division, developed expertise in

the shipment of hazardous materials, issuance of permits for new

engineering methods, and responding to inquiries from industry and the

military on these operations.Education

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The Catholic University of America

Bachelor of Chemical Engineering

United States Coast Guard

Certificate in Explosive Loading Supervision

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