Manager Manufacturing
Resume:
DONALD G. PRICE
DONALD G. PRICE
Louisville, KY 40219
***.*****.*****@*****.***
MANUFACTURING / OPERATIONS MANAGER
Manufacturing Manager with over 20 years experience in the Biotechnology
/ Pharmaceutical industry. Organized and effective manufacturing manager
with a heavy emphasis on continual process expansion. Proven ability to
create and lead highly proficient teams focused on meeting heavy production
demands.
* Productivity & Cost Reduction * Six Sigma Lean Manufacturing Yellow Belt
* Proven Talent Discernment * Twenty Years Working in FDA, ISO Environments
* Policy Development * Conducting process failure investigations
* Finding innovative solutions * Contract Negotiation
PROFESSIONAL EXPERIENCE
Shire Regenerative Medicine, La Jolla, CA 1997 – 2013
(Formally Advanced BioHealing)
Associate Director, Manufacturing (2011-2013)
* 16 years manufacturing human bio-engineered skin substitutes. Dermagraft
and TransCyte are cornerstone technologies in the field of regenerative
medicine.
* Manage all aspects of manufacturing at the La Jolla facility ensuring
production demands are met for two FDA licensed products.
* Responsible for five departments coordinating the work of 65 employees
working multiple shifts across a seven day work week.
* All Production performed under FDA (21 CFR 820) & ISO (13485) standards.
* Sitting member of Materials Requirement Planning (MRP), Materials Review
Board (MRB) and Change Control Board (CCB).
* Chair of Strategic Operations team.
* Plan, execute and maintain a $10M budget (operations and capital) – within
5% the previous six years.
* Spearheaded 5S Kaizen efforts for several aspects of the production process.
* Negotiate contracts with numerous vendors.
Advanced BioHealing, Inc., La Jolla, CA 1997 – 2011
(Formally Smith & Nephew Wound Management)
Sr. Manager, Manufacturing (2006-2011)
* Successfully resumed Dermagraft and TransCyte production after both being
off the market for an extended period of time (Jan 2006 to Aug 2006).
* Extensively involved in the remodel of a 15K Sq Ft class 10K Clean Room,
involving the validations of the environment, equipment, process and operators.
* Recipient of the 2010 Advanced BioHealing Leadership award, Leader of the Year.
* Met or exceeded all production demands during an exceptional period of growth
of 45% over a four year period. Dermagraft sales increased from $27M to $256M
(2007 through 2011).
* Establish and maintain the organizations Master Production Schedule.
* Ensure staffing demands met, proper training performed and all operator
qualifications executed.
* Plan, execute and maintain a $5M department budget.
* Establish and meet personal and department goals, often exceeding
expectations.
* Actively involved in the capacity planning of Dermagraft, providing key insight
and background from 13 years of Dermagraft and TransCyte production experience.
Smith & Nephew Wound Management, La Jolla, CA
Supervisor, Manufacturing (2002-2006)
* Responsible for three teams comprised of 18 employees.
* Ensured production demands were met in the final stages of the organizations
key products, TransCyte & Dermagraft. This included tissue growth using
bioreactors, final packaging & cryogenic freezing.
* Streamlined, developed & changed operational SOP’s and batch records resulting
in more effective training and a 50% reduction in batch record size and errors.
* Successfully merged two teams into one fully crossed trained group resulting
in a reduction of manpower by 45% while still maintaining productivity goals.
* Interviewed, hired and trained new employees.
* Chaired process improvement teams and offered key input to others.
Production Lead
1997 –2002
1997 –2002
* Point person on production floor for all product related matters overseeing
the work of Senior and Manufacturing Associates.
* Promoted from Sr. Associate to Production Lead 1999.
* Reduced Operator error within the group by 88%.
* Delegated responsibility for materials, equipment and documentation needs.
* Provided document review with full sign off authority.
* Primary trainer for new personnel.
* Purchased and implemented new equipment ensuring proper qualifications
were performed.
* Cross-trained on other aspects of the manufacturing process.
Hybritech, Inc., San Diego, CA
1991 to 1997
Production Chemist
* Performed protein purification on monoclonal antibody
* Participated in developing and implementing a serum free cell line for use
in hollow fiber bioreactors
* Performed all aspects of cell culture
Sharp Healthcare, San Diego, CA
Programmer/Analyst
* Wrote & maintained software in support of taxes, Payroll and General Ledger
U.S. Army
Aircraft Crew Chief & Squad Leader, Sergeant (E5)
EDUCATION & PROFESSIONAL DEVELOPMENT
* Six Sigma Lean Manufacturing Yellow Belt
Air Academy Associates
* How to Supervise Series
San Diego State University
* Effective Interaction and Tactical Leadership
Development Dimensions International
* Process Improvement Training
San Diego State University
* Project Management Training
Smith & Nephew Corporate seminar
* Graduate - Systems Analysis & Design, Programming
Coleman University, La Mesa, CA
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