Quality Assurance Manufacturing

Brisco L. Harward, PhD, MBA

**** ****** ***, *** **, High Point, NC 27265

Phone: 336-***-**** Email: abnrq7@r.postjobfree.com

SUMMARY

Results-driven leadership professional with broad-based experience in product development, engineering,

and manufacturing. Strengths include:

• Project Management

• Organization and Planning

• Communications across and up/down the organization

• Promoting Team Collaborations and Accountability

• Budget Management

• Innovation and Positive Change Agent

• Managing Client Expectations and Relations

• Results and Outcome Oriented

PROFESSIONAL EXPERIENCE

BANNER PHARMACAPS, High Point, NC

Director, Clinical Supplies (2007 – 2009)

Leader of organization which manufactures polymer-based softgel dosage forms for clinical and formal

laboratory evaluations. Manage all aspects associated with production in Pilot Plant Facility for >15M

units annually, including warehouse management, compounding, encapsulation, finishing, printing and

packaging. Operation of clinical packaging suite, with both bottling and thermoform blister card

configurations. Participation in full production scale-up and technology transfer activities. Increased the

manufacturing productivity by 80% and the clinical packaging by 150% without additional headcount or

capital expense.

• Authored technical investigations and implemented CAPA’s to improve quality of operations in

department.

• Reduced GMP manufacturing deviations by >30%.

• Develop schedule and align workflow so that client project milestones are achieved and income is

generated according to contract terms.

• Participate in internal, client, and agency audits, including PAI.

CARDINAL HEALTH (now CATALENT), St. Petersburg, FL

Senior Manager, Technical Services (2005-2007)

Manage technical services function which supports large softgel contract pharmaceutical manufacturing

facility. Responsibilities include technology transfer, solving difficult manufacturing issues, addressing

client and regulatory requirements for product changes, and income generation from process changes.

• Provided detailed technical process comparisons and assessments to support requests to regulatory

agencies

• Fostered collaborations with R&D and other manufacturing sites to solve common problems and

improve technology dissemination across company boundaries.

• Manage client expectations to balance resource allocation and focus upon strategic priorities.

GLAXOSMITHKLINE, Research Triangle Park, NC

Director of US Applied Technology (1995-2005)

Provide strategic planning, organization, and leadership to a scientific and technology development

function. Manage more than 20 full time employees and additional contract staff. Provide proof-of-

concept prototypes to evaluate new technologies and processes, integrate commercial components to

provide new capabilities, modify existing systems to increase efficiency and expand utilization. Administer

an operating budget up to $5 Million. Coordinate international support with UK Applied Technology group.

B. Harward – Page 2

• Developed internal marketing strategies, including intra-company website, brochures, presentations,

and technology reports to expanded client base; delivered 20-30% sustained growth over a ten-year

period.

• Developed a flexible tablet processing system for Product Development, which avoided manufacturing

interruptions of approx. $100K per day.

• Developed an automated aerosol testing platform, eliminating variation in testing, reduced need for

retesting, and estimated to have global impact of $5 Million annually.

• Implemented a new instrument support model, reducing costs by 12% and improving control and

forecasting based on analysis of actual use and instrument population.

• Implemented a Customer Satisfaction (CUSAT) program to monitor service levels; achieved the

highest satisfaction ratings in the division, and established a division-wide standard in expectation.

• Served as a Rewards & Recognition team leader; enhanced the program to drive employee

engagement and motivation; this program supported multifunctional organization of >900 associates.

Group Leader (1993 - 1995)

Launched and expanded the Prototype Laboratory function. Managed associate scientific staff and

contract personnel.

• Started the internal prototype facility with less than $1 Million in fabrication equipment and a staff of

four.

• Developed customized laboratory systems, including custom software and validation protocols.

• Ensured GLP/GMP/FDA compliance, and maintained instrument calibrations using NIST standards.

• Developed an apparatus for automated biological cell harvesting (United States Patent 5,620,894).

Research Investigator (1989 - 1993)

Start-up and operation of an prototype automation laboratory.

• Developed the Mobile Automated Systems Table (MAST) for robotic automation of USP test

• Facilitated PC interfacing of laboratory instrumentation and analytical instrumentation.

• Introduced bar code technology into the laboratory.

• Developed a fully automated check-weighing system to conduct USP leak rate testing of Metered Dose

Inhalers (MDI’s).

BASF CORPORATION – Fibers Division R&D

Research Chemist I and II (1985-1989)

Support product development and manufacturing

• Included use of NIR, Fluorescence, Image Analysis, and other methods

• Conduct design of experiment (DOE) trials in Pilot Plant

• Quality Instructor for R&D

EDUCATION

PFEIFFER UNIVERSITY

Masters of Business Administration

4.0 GPA

UNIVERSITY OF TENNESSEE

PhD in Analytical Chemistry

• Received Graduate Fellowship at Oak Ridge National Laboratory (ORNL)

• Presented with the J.A. Dean Award in Analytical Chemistry

• Awarded “Outstanding Teaching Assistant”

PFEIFFER UNIVERSITY

B.A. Chemistry

• Graduated on the Dean’s List and with Honors (Cum Laude)

• Received both the Science Division and Honors Scholarships

B. Harward – Page 3

PROFESSIONAL DEVELOPMENT

Some examples of continued training include:

• Building, Leading, and Sustaining the Innovative Organization

• Reinventing Your Business Strategy

• Project Management: A Systems Approach to Planning, Scheduling, and Controlling

• Lean Sigma Advocate Training

• Lean Six Sigma Sponsor Training

• Quality Improvement Process Management

• Quality Education System (QES) Instructor Training

• Maintaining a Harassment Free Workplace

PROFESSIONAL AFFILIATIONS

• International Society for Pharmaceutical Engineering (ISPE)

• American Association of Pharmaceutical Scientists (AAPS)

PUBLICATIONS and PRESENTATIONS

1. “Multipass Spectroelectrochemistry”

a. 35th Southeastern Regional Meeting of the ACS, Charlotte, NC, November 1983; Abstract No. ANAL

264

b. 188th National Meeting of the ACS, Philadelphia, PA, August, 1984; Abstract No. ANAL 68

c. Chemical & Engineering News, September 10 (1984), 37

d. 1985 Spring Meeting of the Electrochemical Society, Toronto, Ontario, Canada, May, 1985;

Abstract No. 597

e. Analytical Chemistry (1985), 57, 1773-1775

2. “Image Analysis in Fiber Research”, BASF Corporation Quality Assurance & Analytical Chemistry

Symposium, New Orleans, LA, February 21-23, 1988

3. “Near-Infrared Reflectance Analysis (NIRA) in Fiber Research”, BASF Corporation Quality Assurance &

Analytical Chemistry Symposium, New Orleans, LA, February 21-23, 1988

4. “Comparison of Spectroscopic Methods to Study the Thermal Degradation of Nylon”, Spring 1988

Technical Conference of the Fiber Society, Asheville, NC, May 12-14, 1988

5. “Spectroscopic Investigations of Catalytic Iridium Carbonyl Species in Sodium Chloroaluminate Melts”,

Journal of Organometallic Chemistry, 429 (1992) 119-134

6. “Robot Method Improves USP Testing of MDIs”, PI Quality Magazine, Vol. 3 September/October 1993,

31-32

7. “Advanced Design & Automation”, Glaxo Research Institute Bioengineering, Glaxo Worldwide

Laboratory Automation Newsletter, Edition 2, December 1993

8. “Fully Automated, Dissolution Profile Testing in a Microsoft Windows® Environment”, International

Symposium on Laboratory Automation & Robotics, Zymark Corporation, October 17-22, 1993

9. “RS-232 Interfacing in the Laboratory: Data Transfer from a Tektronix scope using Serial

Communications”, LabVIEW® User Group Meeting, April 20, 1994, Chapel Hill, NC

10. “LabVIEW for Windows: A Graphical programming Tool for Rapid Automation Prototyping in the

Laboratory”, Glaxo Worldwide Laboratory Automation Newsletter, Edition 3, August, 1994

11. “GRI Bioengineering AD&A Update”, Glaxo Worldwide Laboratory Automation Newsletter, Edition 4,

February, 1995

12. “Laboratory Automation Prototyping using LabVIEW for Windows”, Glaxo Research Institute Poster

Symposium, January 26, 1995

13. “Apparatus for Automated Biological Cell Harvesting”, U.S. Patent #5,620,894 (1997)

14. “Optimizing Value for Intellectual Property Generated by In-House Support Teams”, ALA LabFusion

Conference, Boston, MA, June 12-16, 2004

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