Kenneth S. Sampson

**** *. ****** ***, ****** City, Mo 64151

786-***-****

OPERATIONS / GENERAL MANAGEMENT

PROJECT MANAGEMENT– TECHNICAL TRANSFER– MANUFACTURING MANAGEMENT

Operations professional experienced in Pharmaceutical Solid Dose and Soft Gelatin Manufacturing,

which includes a solid knowledge of processing and related equipment.

SUMMARY OF QUALIFICATIONS:

8 years as Manufacturing Supervisor in the Pharmaceutical Industry

7 years as Manufacturing Manager in the Pharmaceutical Industry

Knowledgeable in all Microsoft applications (Excel, Word, Power Point, Project)

EMPLOYMENT:

Nostrum Labs, Kansas City, MO – March, 2008 – Present

Manager of Tech. Transfer - March, 2008 – Present

Duties to include:

• Oversee Technical Transfer of Equipment and Process

• Collaborate with R&D in new product development to be scaled up to manufacturing size equipment

in accordance with SUPAC.

• Write protocols for qualifying new equipment to be used in the manufacturing pharmaceutical

Products.

• Write protocols for Process Validation.

• Write protocols for Cleaning Validation

• Develop and revise SOP's for new and existing equipment and processes

Swiss Caps, Miami, FL – June, 2004 – October, 2007

Director of Manufacturing - June 2007 – October 2007

Duties to include:

• Oversee manufacturing operations

• Worked with planning to achieve 83% schedule efficiency.

• Responsible for the production of 7 billion soft gelatin capsules for 2007

• Develop and revise SOP's for new and existing equipment and processes

• Developed a certification programs for all operators working in each department (weighing, milling,

gelatin processing, encapsulation, inspection)

Director of Validation – November 2005 – June 2007

Duties to include:

• Oversee Quality and Validation operations

• Responsible for ensuring the quality of the product through managing the quality systems (AQL’s,

incoming product inspections).

• Reformulated OTC daytime formula using alternate decongestant and developed the process to

manufacturing through validation activities (Process, cleaning).

• Transferred a starch gelatin process technology from Switzerland to Miami.

• Implemented and tracked other product projects delegated to technical service staff.

Pharmaceutical Manufacturing Manager - June 2004 – November 2005

Duties to include:

• Oversee OTC manufacturing operations

• Implemented a 6-month plan to validate and start up OTC manufacturing.

• Responsible for the production of 24 million soft gelatin capsules per month

• Develop and revise SOP's for new and existing equipment and processes

• Developed and executed protocols for Process and Cleaning Validation

• Collaborate in writing protocols for qualifying new equipment for the use in manufacturing

pharmaceutical Products. Implement manufacturing standards

Impax Labs, Hayward, CA

Contracting Manufacturing Support (2nd Shift) - February 2003 – September 2003

Duties to include:

• Oversee manufacturing in the Granulation, Blending and Coating operations

• Implement a Safety Program and Training Program for a staff of 43 technicians

• Develop and revise SOP's for new and existing equipment and processes

• Collaborate in writing protocols for qualifying new equipment for the use in manufacturing

pharmaceutical Products. Implement manufacturing standards

• Transferred coating technologies and provided technical support.

Vintage Pharmaceuticals. Charlotte, NC

Manufacturing Manager - October 2001 – October 2002

Duties to include:

• Oversee manufacturing in the Weighing, Blending, Compression, Encapsulation, Coating and

Branding operations

• Responsible for the production of 200 million tablets and capsules per month

• Implement a Safety Program and Training Program for a staff of 33 technicians

• Develop and revise SOP's for new and existing equipment and processes

• Collaborate in writing protocols for qualifying new equipment for the use in manufacturing

pharmaceutical Products. Implement manufacturing standards

Purepac Pharmaceuticals - Ellizabeth, NJ

Manufacturing Manager - November 1999 – October 2001

Duties to include:

• Supervise 22 operators in the Compression, Encapsulation, Coating and Branding operations

• Responsible for the production of 220 million tablets and capsules per month

• Implement a Safety Program and Training Program for a staff of 22 technicians

• Develop and revise SOP's for new and existing equipment and processes

• Collaborate in writing protocols for qualifying new equipment for the use in manufacturing

pharmaceutical Products. Revise manufacturing standards

• Wrote protocol for scale up on targeted products using SUPAC guidelines

• Implemented a 6-month plan to proactively manage our production throughput. Using the 6-month

plan we were able to coordinate scheduling activities for production with the Lab and Packaging

Departments

Zenith Goldline Pharmaceuticals, Inc. - Miami, FL

Manufacturing Supervisor - February 1996 – November 1999

Duties to include:

Schein Pharmaceuticals (Danbury Pharmacal), Inc. - Carmel, NY

Manufacturing Supervisor - Compounding Department - August 1991 - January 1996

• Collaborate in writing protocols for the transferred older products from the older Danbury facility to the

newly built facility in Carmel NY

EDUCATION:

Carmel High School: Graduated in 1983

Western Connecticut State University: 1984 – 1986; Major: Chemical Engineering

Certification: First Aid, CPR, Fire Brigade, HAZMAT, member of the Safety Committee and received

training in MRPII applications.

ISPE member Since 2004.

SKILLS:

Operation of the following:

Gemco Double Slant Cone Blenders (1,3,10,30 & 75 cu ft), Patterson Kelley V Blender (5,10 and 50 cu ft)

WSG120 & 200 Glatt Fluid Bed Dryer, AMF Glen Planetary Mixer, Day Ribbon Mixer, Fitzpatrick

Chilsonator Fitzpatrick Communitor (Fitzmill), Killian Tablet Press, Kikusui 836 & 845 Tablet Press,

Manesty Nova Press Korcsh Pharmapress, Type 8 Encapsulator, Type 10 Encapsulator, MG2

Encapsulator, H&K Bosch Encapsulator, Accela Cota (Teko Spray Pump System, Binks Spray System

and VAU Spray System), API Shrink Bundler, Indercon Induction Sealer and New Jersey Labeler

Soft gelatin processing: Fill preparations, gelatin processing, and encapsulation using Kamata

encapsulators.

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