Objective 

Pharmaceutical Processing Director level postion allowing for parlay of
demonstrated organizational, innovation, process development, and process
efficiency skills proven by 12 years of successful experience in the chemical and
pharmaceutical processing industries.

Profile 

Motivated, manufacturing professional with strong entrepreneurial skills and a
successful 12-year track record of process management, development and
improvement. Talent for developing processes that are extremely efficient and
effective as well as rehabilitating existing processes to save time and improve
profitability. Diplomatic and tactful with professionals and non-professionals at
all levels. Accustomed to handling sensitive, confidential records. Demonstrated
history of managing multiple departments and personnel while maintaining an
extremely high level of quality production within a volatile industry.
Flexible and versatile - able to maintain a strong sense of focus and guide
others while under extreme pressure. Poised and competent with demonstrated
ability to easily unify departments company wide. Thrive in deadline-driven
environments. Excellent team-building skills.
Skills Summary 
* Project Management
* Report Preparation
* Technical Writing
* CAPA
* Tech Transfer
* Process Validation
* Scheduling
* API Synthesis
* Aseptic Techniques
* Process Improvement
* Research and Development
* Formulation

Professional Experience 

DIRECTOR OF OPERATIONS - COLDSTREAM
* Responsible for Manufaturing, Facilities, Safety, Materials Management and
Engineering Departments at a state of the art Contract Manufacturing Facility
utilizing Barrier Technology (Isolators) to manufacture Cytotoxic, Highly Potent,
Radio-Lableled and Generic sterile parentherals and medical devices.
* Part of executive staff responsible for meeting quarterly and annual fiscal
goals while growing the business and manufacturing operation.
* Rehabilitation of out-dated and in-efficient manufacturing practices to
increase plant timelines and throughput.

SENIOR PROJECT MANAGER - COLDSTREAM
* Responsible for coordination of Contract Manufacturing Activities agreed upon
with various clients.
* Orchestrated different task levels from Formulation Development through
Commercial Manufacturing.
* Procured required materials, documentation and equipment for projects of
varying complexity.
* Managed invoicing of Sales Orders and tracking of billable tasks/hours on a
weekly, monthly and quarterly basis.
* Responsible for managing company wide and individual Gantt Charts to
communicate project progress.

PRODUCTION OPERATIONS MANAGER - PHARMAFORCE
* Manage an FDA approved sterile manufacturing facility with an annual output of
approximately 4 million units.
* Manage staff of approximately 110 hourly personnel and five salaried
supervisors.
* Scheduling of personnel from multiple departments on a weekly basis to meet a
highly volatile production schedule while maximizing efficiencies and minimizing
operating costs.
* Manage the entire facility operation which utilizes a three shift, 24 hour per
day, 5 day per week manufacturing schedule.
* Orchestrate the resources necessary to drive commercial products from
component and raw material preparation stages to shipment and sale of finished
drug products specializing in generic sterile injectables, ophthalmics, and otics
while maintaining an extremely high level of quality and integrity.
* Integral part of managing a privately held company by collaborating with both
senior executive staff and departmental managers and supervisors to make sound
business decisions in an extremely competitive sector of the pharmaceutical
industry.

PROCESS DEVELOPMENT/PROCESS IMPROVEMENT - PHARMAFORCE
* Responsible for transferring laboratory developed processes to the
manufacturing facilities.
o Extensive experience developing efficient processes for ANDA batches that meet
regulatory requirements while keeping investment in raw materials and equipment
to a minimum.
* Responsible for translating laboratory data and notes into manageable GMP
batch records.
* Manage the scale up of approved ANDA batches to planned commercial size from
authoring batch records through management of process equipment and materials.
* Experience researching and sourcing highly efficient and cost effective
equipment to meet the processing needs of extremely challenging finished drug
products.

ASEPTIC MANUFACTURING: COMPOUNDING/LIQUID FILLING OPERATIONS
* Manage all aspects of day-to-day manufacturing operations as related to
aseptic manufacturing.
* Extensive experience compounding and filling finished drug products which
include simple solutions, oil based products, cytotoxic compounds, lyopholization
conversions, injectable suspensions, and ophthalmic suspensions.
* Responsible for operating a lean manufacturing team with an extremely high
output: 1.2 million units per quarter utilizing a team of 10-12 aseptic
operators.
* Integral part of a team that brought to market the first approved generic
version of a widely used injectable suspension that has been commercially
available for the last 44 years without a viable therapeutic equivalent.

Employment History 
COLDSTREAM LABORATORIES INC. - LEXINGTON, KY
Director of Operations, 2011
PHARMAFORCE INC. - HILLIARD, OH
Production Operations Manager, 2007 to 2011
GEORGIA PACIFIC - COLUMBUS, OH
Production Supervisor, 2000 to 2007
MARATHON ASHLAND PETROLEUM - ASHLAND, KY
Maritime Operations, 1999 to 2000

Education 

FRANKLIN UNIVERSITY - Columbus, Ohio
Business Administration Major, 2009 GPA: 3.7/4.0

THE OHIO STATE UNIVERSITY - Columbus, Ohio
Mechanical Engineering Major, 1995-1998 GPA: 3.2/4.0