Manager Project

Objective: Contribute to the success of an innovative organization and work

with talented individuals in the manufacturing, engineering, and quality

disciplines.

Summary of qualifications

1. Over thirty years experience in the Pharmaceutical and Health Care

industries utilizing cGMP guidance and FDA regulation to create

quality products.

2. Participated in numerous successful FDA (CDER and CBER) compliance

audits, face-to-face and behind the scenes.

3. Performed numerous Internal, Material Supplier and Third Party Quality

Audits.

4. Developed and organized quality documentation systems, (i.e. SOPs,

Change Control, CAPA, IQ, OQ, and Process Validation). Hands on

validation of packaging and manufacturing equipment.

5. Developed compliance training systems where department managers'

partner in the creation and review of training requirements by job

function, and assess individual and department compliance performance.

6. Developed standard training modules and trained employees in the areas

of SOPs, cGMP, Cleanroom Technology, Chemical Processing of Active

Pharmaceutical Ingredients (API), Solid Dosage Forms,

Packaging/Labeling, OSHA, FDA, DEA, DOT and ATF Regulation.

7. Developed the sterilization process for a unique aseptically produced

bio-pharmaceutical drug product, improving overall drug product

quality, and increasing the facility's production capacity by 100%.

8. Increased the yield of a controlled (CII) API chemical synthesis by 10

percent.

9. Completed the project management duties for dozens of small to

intermediate sized capital equipment projects on time and on budget.

Most notable the build-out of a Class 100 Cleanroom.

10. Proficient in Microsoft Office Suite and MS Project.

11. Proficient in the handling of DEA Controlled Substances.

Work History

HALO PHARMACEUTICAL INC., Whippany, NJ

January 2009 - September 2010

Job Title: (2009 - 2010) Operations - Director of Pharmaceutical

Manufacturing/Packaging

Principle Responsibilities:

Establish the business plan and personnel development in the following

areas of Pharmaceutical Manufacturing and Packaging:

. Chemical Processing, CII Active Pharmaceutical Ingredient

. Aseptic Processing, Compounding, Fill and Finish

. Liquid Processing, Compounding, Fill and Finish

. Tablet Manufacturing, packaging and labeling

. Supplier Auditing, component and material review and approval

ABBOTT LABORATORIES

2002- December 2008

Job Title: (2004-2008) Operations - Manufacturing Manager

Principle Responsibilities:

Manage the production and business issues in the following areas of

Pharmaceutical Manufacturing:

. Chemical Manufacturing, CII Active Pharmaceutical Ingredient

. Ointment Manufacturing (Sterile Biopharmaceutical), Compound and Fill

. Liquids and Semi-Solid Manufacturing

. Solid Dosage Forms (Tablet) Manufacturing (Including DEA CIIs and

CIIIs)

. Supplier Auditing, component and material review and approval

ABBOTT LABORATORIES (continued)

Job Title: (2002-04) Operations - Packaging Manager

Principle Responsibilities:

Manage the production and business issues in the following areas of

Pharmaceutical Packaging:

. Primary and secondary packaging including:

. Label Control

. Blister Packaging (Trade packs, Samples and HUDs)

. Oral Solid and Oral Liquid Dosage Forms (Tablets and Syrups)

. Semi-Solid Dosage Forms (Suppositories/Ointments)

. Supplier Auditing, component and material review and approval

BASF Corporation, Knoll Pharmaceutical Company

1989-2002

Job Title: (2000-2002) Quality Assurance - Manager, Training and

Documentation Systems

Principle Responsibilities:

. Implement a Division wide Electronic Document Management System

(Documentum)

. Develop and implement annual Master Training Plan

. Design and implement a comprehensive Validation Change Control System

. Establish core technical training requirements for each job

classification at the site

. Develop baseline cGMP training modules

. Establish a Training Material Library

Job Title: (1998-00) Quality Assurance -Training Manager

Principle Responsibilities:

. Provide guidance and leadership in the development, design-

standardization and implementation of the training program at the site

. Assess the site's training needs and select or develop appropriate

training courses/modules to enhance employee performance.

. Provide guidance on the use of alternative training media including

competency assessments tools.

. Establish and maintain a system for scheduling and documenting

training events, including the periodic audit of the training system

and providing return on investment (ROI) metrics to upper management.

Job Title: (1995-98) Engineering/QA - Project Manager

Principle Responsibilities:

1. Manage the on-time, on-budget completion of small and intermediate

technical projects. Collect and disseminate project information.

Identify, analyze and respond to project risk. Solicit and select

goods and services. Assure the most effective use of human resources

while providing overall project quality, assurance and control.

Job Title: (1993-95) Engineering/QA - Validation Specialist

Principle Responsibilities:

. Evaluate manufacturing equipment using engineering design and purchase

specifications to develop punch list items or recommend equipment

release (factory and site acceptance testing).

. Develop and execute Installation Qualifications (IQs) on packaging and

manufacturing equipment.

. Develop and execute Operation and Performance Qualification protocols

(OQs/PQs), complete testing and compile summary reports for packaging

and manufacturing equipment and utilities.

. Design Process Validation Protocols, train and supervise production

personnel during testing and compile validation summary reports.

. Supplier auditing, factory and site acceptance testing.

BASF Corporation, Knoll Pharmaceutical Company (continued)

Job Title: (1991-1993) Manufacturing - Production Supervisor

Principle Responsibilities:

2. Supervise personnel in the production of Semi-Solid, Liquid and

Sterile Dosage Forms. Consistently reproduce high-quality products,

efficiently in accordance with site SOPs and cGMPs.

3. Develop core competencies and technical abilities of subordinates

through the use of continuous improvement, planning, empowerment, and

team building techniques.

4. Provide compliance training in the relevant areas of FDA, DEA and OSHA

regulation, company policies and procedures.

Job Title: (1989-1991) Manufacturing - Pharmaceutical Operator

Principle Responsibilities:

. Weigh, Granulate/Blend, Compress and Film Coat Solid Dosage Forms

5. Compound, Aseptically Fill and Terminally Sterilize Ampoules and Vials

in accordance with Master Production Records, Standard Operating

Procedures and cGMPs.

Beecham Inc., Consumer Products Division

1979-1989 Manufacturing

Principle Responsibilities:

. Compound Consumer Heath Care products

. Blow-Fill-Seal, Injection Molding Technician (ALP)

EDUCATION

6. AA, Fairleigh Dickinson University (Liberal Arts)

Professional Development

7. Dale Carnegie - Public Speaking

8. Ken Blanchard - Situational Leadership

9. Langevin - Certified Training Manager

10. International Institute of Learning - Project Management Professional

(PMP Program)

11. Development Dimensions International - High Performance Teams and Team

Building

12. Kepner Tregoe - Problem Solving, Decision Making and Root Cause

Analysis

13. Technical Training Systems - Developing High Performance Training

Systems

. PDA - Cleanroom Management, Pharmaceutical Filtration, Isolation

Technology, Application of CIP/SIP to the Pharmaceutical Industry,

Validation of Steam and Dry Heat Sterilization, Validation of

Radiation Sterilization, Manufacturing/Validation of Active

Pharmaceutical Ingredients, etc.

. ISPE - cGMP Compliance within the Pharmaceutical Industry, Aseptic

Facility Design, Writing Standard Operating Procedures, Equipment

Commissioning and Qualification, Quality by Design, Design Space, etc.

Professional affiliations

. Parenteral Drug Association (PDA)

. International Society of Pharmaceutical Engineering (ISPE)

. Professional Project Management Association (PPMA)

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