Operations management, Manufacturing

KENNETH P. SMITH

**** ****** **** ( Heber Springs, AR 72543

941-***-**** ( *********@*****.***

Director of Manufacturing Operations

Proven professional and excellent team builder/collaborator with fifteen

years related experience in the role of Pharmaceutical Manufacturing

Director of Operations with strong proficiency in cGMP drug product

manufacturing. Experienced in technology transfer, scale-up and late phase

clinical development. Process Development experience with a solid

understanding of pharmaceutical development process. Competency in the

principles and practice of cGMP's and associated regulator considerations

in a pharmaceutical environment, to include process, equipment, and

facility validation. Experienced in cleaning validation. Experience with

laboratory and pilot-scale manufacturing.

PROFESSIONAL EXPERIENCE

CONSULTANT - OPERATIONS/COMPLIANCE/EH&S

FORESIGHT, LLC ( Heber Springs, AR ( 4/2012-Present

Charged with orchestrating program and process development for Start-up

Company, including administration, operations, compliance, safety,

scheduling, training, logistics, inventory control, and business

development. Held accountable for providing sufficient resources and

direction for sales, pricing, marketing, and product development functions

for North American market. Attract and develop talented employees, and

develop and meet operating budget parameters. Design single- and multi-year

strategic plans, meeting targets and deliverables. Optimize cost

effectiveness of new systems based on sound market analysis. Establish

effective inventory control and practices, promoting smooth communication

with operations. Enhance executive leadership's decision through provision

of accurate, concise weekly and monthly reporting. Provide leadership to

company's HR function, creating benefit/insurance packages. Sparked growth

increasing annual sales from $45K to $400K. Created and introduced

quality/compliance policies and safety programs standards for several large

Fortune 500 oil corporations. Developed legal and professional structures

with employee handbook.

RIO RIG SERVICES, INC. ( Heber Springs, AR ( 3/2011-4/2012

Recruited to develop and execute safety program consistent with programs

found within three large corporations drilling in Fayetteville Shale

program. Ensured compliance with production and operations requirements

related to staff hiring and drug testing, job assignments and scheduling,

and position descriptions, as well as implementation of Lean Manufacturing

environment. Achieved no lost time accidents or OSHA recordables through

development of safety program from scratch to support ISNetworld

regulations and compliance with three major drilling operations, along with

introducing accountability and concise work records at all job sites.

Increased workforce by 200%, while enhancing company's reputation by

maintaining highly professional relations with operating superintendents

from major drilling companies.

ANGIOTECH PHARMACEUTICALS ( Sarasota, FL ( 4/2008-2/2011

Company developing and distributes Biologic Products.

Director of Manufacturing

Shepherded start-up of plant designed to produce Phase III clinical

biologic product, managed all areas of startup of pilot plant to include:

validation, team building and documentation development and review.

Orchestrated technical transfer of product within 99% disposable process.

Guided clinical production, interfacing with technical operations to ensure

compliance with safety and environmental goals, standards, and regulatory

requirements. Utilized biotechnology expertise to effectively coordinate

technical projects with strategic plans, and directed new product

introductions and transfers by analyzing production plans and capacity

constraints. Provided consultation and leadership related to operations,

overseeing staff supervision; Interpreting operational and financial data;

and developing, monitoring, and approving budgets/expenditures. Generated

operational cost savings by introducing targeted business applications,

developing and executing policies and procedures. Evaluated new products,

including specifications and quality standards, initiating interventions to

support Lean business processes. Incorporated safety, environmental, cost,

and operational goals with target expectations. Designed and executed

improvement plans and indicators for operations and quality teams, and

develop action plans for production flow functions. Guided staff training

processes, anticipating future needs. Reinforced strategic vision and

objectives, and managed operational projects.

Accomplishments:

. Orchestrated FDA-regulated manufacturing plant's start-up operations from

scratch, including staffing and implementation of pharma-quality

engineering design.

. Strengthened product marketing by conducting investor tours of plant

operations, and presented diverse business options to investors for

project timelines, financials, and input volumes and scale from pilot to

commercial release. Interfaced and networked extensively with contractors

to provide high quality services and meet very aggressive timelines.

CSL BEHRING ( Kankakee, IL ( 1/2001-3/2007

Biopharmaceutical manufacturer, global leader within plasma protein

biotherapeutics industry.

Department Head - Basic Fractionation

Directed fractionation, coagulation, and alcohol inventory departments

within union-represented environment. Designed and executed manufacturing

strategies by comparing current and new product lines to meet or exceed

production goals. Monitored inventory control and quality manufacturing

consumption, as well as database reconciliation and internal audits.

Reviewed/reported inventory control results. Ensured department's

compliance with FDA and European/Asian regulatory requirements. Guided

process improvement and monitored scientific trends while creating platform

for new technology implementation. Monitored annual shutdown maintenance

and improvement projects, along with validation, change control and

engineering. Created departmental annual operation budget, controlling

expenses within .06%. Oversaw 19 supervisors, 6 production coordinators, 4

process engineers and 200+ union employees.

Accomplishments:

. Reduced production deviation rate by 500% within department, and reduced

staff grievances from 60 to zero within union-represented environment.

. Recognized for outstanding talents and performance by receiving several

promotions over 4-year period from Production Supervisor and Plant

Superintendent to Department Head. Generated sustained success without

science degree by building strong teams and allowing talented staff to

achieve optimal success.

Career Note: Prior position as Plant Superintendent with Chiquita Brands

International. Details upon request.

EDUCATION / LICENSURE

Bachelor of Science in Parks and Recreation Administration

Eastern Illinois University, Charleston, IL

State K Waste Water License

COMPUTER SKILLS

Microsoft Office Suite ( SAP ( Mastercontrol ( Laboratory Management

Information System

PROFESSIONAL AFFILIATIONS

International Society of Pharmaceutical Engineers

Parentaral Drug Association

ISNetworld Compliance

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