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KIERAN
SCHMALZL, Ph.D.
14 Fisher Road Ÿ Greenville, South
Carolina 29121
864-580-1212 Ÿ kieran@gmail.com
REGULATORY
& QUALITY AFFAIRS / NEW BUSINESS DEVELOPMENT
Top
tier chemical industry specialist with wide range of highly developed skills in
regulatory compliance, quality assurance and new market research based on over 20
years experience. Results-driven leader who can interface with EPA, FDA, OSHA
and EU-REACH to insure corporate compliance with regulations, reporting,
technical and commerce compliance, and government relations. Able to develop
new corporate business through market and customer research, investigating new
technologies leading to new products; complete follow through from concept to
market. Expertise in using ISO9000 training, six sigma skills and knowledge of
government relations to meet, exceed and grow corporate quality goals.
Change
Management Ÿ Project
Management Ÿ Team
Leadership / Motivation Ÿ Employee
Engagement
Business
Development Ÿ Client
Relations Ÿ Market
Analysis Ÿ Needs
Assessment Ÿ Product
Marketing
QC/QA Ÿ Ops Management Ÿ Process Improvement Ÿ Risk Management Ÿ OSHA / Regulatory
Compliance
New
Business Development Using Stage Gate Process Ÿ Problem Solving Using Six Sigma Techniques
PALMETTO CHEMICAL
SPECIALTIES, INC., Greenville, South Carolina Ÿ 3/2007 – Present
Consulting company
specializing in EPA TSCA, part 158, TRIS, RECRA relations for compliance and
submission of documentation required by EPA and FDA annually for placing
products into commerce. Interaction with FDA in biomedical devices, chemicals
used to manufacture devices and products for secondary food contact. Supplier
of chemical knowledge and expertise in selected areas of organic, polymer and
fluorine chemistry.
Regulatory Compliance
Relations Consultant
Research
regulatory status for clients’ chemical products for compliance with laws in
specified countries for chemical sales. Manage required testing of compounds to
satisfy compliance regulations and document compounds for government
registration; provided written documentation of compliance to clients and
government agencies.
Achievements:
Ÿ
Successfully filed EPA-TSCA PMNs and other
exemptions to introduce new products into commerce for company clients.
Ÿ
Worked with client to utilize EPA’s
regulations to become sole US supplier of a family of compounds.
Ÿ
Saved client multiple thousands of dollars by
ascertaining very early that new products were not EPA registered and would
have to be registered before being sold.
Ÿ
Provided guidance during new product development
projects based on the regulatory status of targeted compounds designated for
commerce.
Ÿ
Defended client against an EPA-TSCA violation
suit saving $3-4M in fines and loss of business.
ORTEC, INC., Easley,
South Carolina Ÿ
5/2008 – 3/2011
Ortec is a leading
polymer technology, medical material and custom chemical synthesis company.
From small scale to full product commercialization, Ortec develops innovative
and timely solutions for both manufacturing and product development.
New Business Development
Team Leader
Charged
with new market research, customer discovery, product identification that fit
new market area; chemical creation of new products, scale-up process work to
manufacturing. QA/QC leader for new products; developed R&D improvements
resulting in improved efficiency. Monitored the industry for technology and
business opportunities using skills in market R&D with trade and Internet
publications, and network contacts. Laboratory skills acquired through 20+
years experience.
KIERAN
SCHMALZL, Ph.D.
Ÿ Page 2 Ÿ
864-580-1212 Ÿ kieran@gmail.com
Achievements:
Ÿ
Led a cross-functional team in development of
a new business resulting in new sales to new customers. Drove product and
process development for manufacturing and working with marketing/sales to
identify markets and customers.
Ÿ
Designated as EPA agent for new business
development and filed compliance documents for new compounds placed in
commerce.
Ÿ
Defended the company against a multi-million
dollar EPA suit for previous TSCA violations, reducing fines from $3-4M to
$27.5K (EPA Region 4).
Ÿ
Improved R&D efficiency through
automation of experiments and equipment; delayed need to hire additional lab
technicians and increased throughput by 50%.
ABCO INDUSTRIES INC –
EASTMAN CHEMICAL, Roebuck, South Carolina Ÿ 8/1990 – 3/2007
Manufacturer of
acrylic and styrene-acrylic aqueous emulsions for the textile, sealants,
printing (ink) food wrapper/paper and coating industries. Company also
manufactured specialty monomers used in biomedical device manufacture.
Team Leader Custom
and Toll Clients
Provided
supervision for R&D technicians and QC staff. Developed laboratory and
manufacturing processes and devised analytical test methods. Conducted
costing/pricing and ROI for new products and processes. Participated in
customer technical and sales interaction. Managed $10-15M custom and toll
manufacturing business area.
Achievements:
Ÿ
As cross-functional Team Facilitator, led
improvements to manufacturing that reduced batch cycle time by 50% resulting in
savings of $1-2M, 100% improved plant efficiency and eliminated need for
increased staff and shifts of operation.
Ÿ
Led R&D/Sales team in the development of
a unified and codified new product development process that shortened
development time by 3-6 months saving thousands in costs; insured regulatory
compliance from an early project start.
Ÿ
In the QC Manager role, participated in ISO
registration by rewriting QC SOP’s and analyses procedures to conform with ISO
and cGMP/GLP regulations, resulting in less rework due to QC improvements,
enhanced associate morale and greater retention, and improved instrumentation faster
analyses and cost reduction.
Ÿ
Earned certification as ISO9000 internal
auditor and six-sigma green belt for emulsion biocide optimization project.
Ÿ
Designed and assisted with engineering and construction
of specialty reactive monomer plant; supervised plant operation and staff.
Career
Note: Polymer
Technology Corp, a division of Bausch & Lomb
Manager Technical
Product Support; Production Manager; Research Chemist.
PUBLICATIONS
“Reaction of Hydrogen with Aromatic
Compounds in a 13.6 MHz Discharge”, Plasma Chemistry and Plasma
Processes.
“Mechanism of Anodic Cleavage of
Benzyl Ethers”, Journal of the American Chemical Society.
Plasma
Chemistry and Applications, Gordon Conference, Tilton, New Hampshire
KIERAN
SCHMALZL, Ph.D.
Ÿ Page 3 Ÿ
864-580-1212 Ÿ kieran@gmail.com
CERTIFICATIONS
ISO9000 Internal
Auditor
Six-Sigma Green Belt
EDUCATION
Postdoctoral
Fellowship
University of
Minnesota Ÿ
Minneapolis, Minnesota
Research
with Dr. Larry Miller involved two projects: the synthesis and mechanistic
aspects of the electrochemical oxidation of benzyl ethers and the investigation
of the fundamental aspects of gaseous organic radio frequency plasma reactions.
Managed research group during Dr. Miller’s sabbatical absence.
Ph.D. Organic
Chemistry
University of
Nebraska Ÿ Lincoln,
Nebraska
Research under Dr.
Henry Baumgarten encompassed the widely used synthetic methods of organic
chemistry for the investigation of cyclic and acyclic organonitrogen compounds,
synthesis of reactive vinyl amino-monomers and their polymerization and the
development of novel synthetic electroorganic techniques.
Bachelor of Science
in Chemistry, Minor in Physics
Hillsdale College Ÿ Hillsdale, Michigan
ADDITIONAL
TRAINING
Management,
Business and Leadership Courses
Simons School of
Management and Economics, University of Rochester Ÿ Rochester, New York
Carol School of
Management, Boston University Ÿ Boston,
Massachusetts
Leadership Training
and Techniques, Center for Creative Leadership Ÿ Greenville, North Carolina
PROFESSIONAL
MEMBERSHIPS
American Chemical
Society
Royal Society of
Chemistry (UK)
Western Carolina’s
Section, ACS: Chair (95-96), Secretary / Treasurer (94-95)
Member of American
Chemical Society Divisions:
Organic Chemistry
Fluorine Chemistry
Polymer Chemistry
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