Supply Chain Manager
Resume:
K E V I N C. M I O D O N S K I
** ***** **. **********, ** 05301
***@******.****.***
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PROFESSIONAL PROFILE:
Proven senior executive with extensive experience in manufacturing and
supply chain management. Broad experience and success in pharmaceuticals,
medical devices and food supplements. Experience has included multiple
start-ups, CMO management and multi-nationals. Product experience includes
vaccines, parenterals, oral dose, semi-solids, API's and medical devices.
Key Contributions included:
. Managed multi-facility manufacturing sites
. Lead operations groups for 3 bio-pharm start-ups and 1 turn around
. Coordinated design and construction of multiple manufacturing
facilities
. Lead multiple efforts of process development, scale-up, validation and
commercialization
. Extensive project management experience
. Lean manufacturing implementations
. International experience and corporate management
. Rationalization of sourcing and warehousing operations
. Managed both domestic and international contract manufacturing
partners
. Assisted raw material vendors in increasing yields
. Implementation of supply chain systems and improvements
. Improving inventory turns
. Implementation of manufacturing efficiencies
. Company wide sustainability initiatives
. Working with FDA, DEA, OSHA, State Dept of Pharmacy and local Govt.
agencies.
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RELATED EXPERIENCE:
Vice President Operations, New Chapter Inc. (Brattleboro,VT) 2009-Present
Responsible for Manufacturing, Supply Chain, Logistics and Engineering
activities of a GMP Vitamin and Supplement manufacturer.
Accomplishments
-Identified and instituted >$500k in cost avoidance in first months with
firm
-Re-organized the operations and quality groups to ensure compliance to 21
CFR 111 and 211
-Rationalized sourcing and contract manufacturing operations resulting in
first year cost saving of >$750,000.
-Managed multiple CMO suppliers.
-Developed new contacts in China, India, Africa, Europe and the US for key
raw materials sourcing
-Worked with raw material vendors and increased yields valued over
$200k/yr.
-Managed operational evaluation of expansion of business into Canada
-Modified ordering and stocking practices, which resulted in a $5 million
decrease in inventory and moved annual inventory turns from 2.4 to 3.2+.
Chief Operating Officer, Harmony Labs Inc. (Kannapolis, NC) 2006 - 2009
Responsible for the operations of a very fast growing pharmaceutical
contract manufacturing business which included supply chain, purchasing,
manufacturing, logistics, facilities, human resources and engineering.
Accomplishments
-Coordinated manufacturing and operation to allow firm to grow from ~$16mm
to ~$50mm in three years time
-Identified and coordinated hiring of; VP of R&D, VP of QA, Director of
Quality Control and Director of Regulatory Affairs
-Instituted strategic alliances and implemented numerous contracts with key
suppliers in the US, Europe and Asia
-Coordinated the retrofit of a 136,000 sq.ft. building into a state of the
art GMP manufacturing facility and a 35,000
sq.ft. building into a state of the art lab facility.
-Identified and coordinated acquisition of appropriate equipment to allow
for increased production volumes
-Developed and implemented a plan to grow manufacturing from $1.2MM per
month to >$3MM per month and
reduced per unit costs ~10% .
-Coordinated the firm's first ERP implementation.
-Facility obtained a no 483 for its first FDA GMP inspection
KEVIN C, MIODONSKI (cont.)
Vice President, Development and Manufacturing, Cell Therapeutics Inc.
(Seattle, WA) 2004-2006
Responsible for all operational activities for Biopharmaceutical start-up
including; API, FP analytical development, coordination of all
manufacturing and supply chain activities for European Operations and US.
Developed and implemented strategy for product scale up of a highly complex
API manufacturing process and plan for product commercialization.
Developed supply chain to secure all necessary raw materials and clinical
and commercial products to support NDA approval.
Accomplishments
-Reviewed and negotiated numerous contract manufacturing agreements and
identification of new contract manufacturing partners which resulted in
cost savings of >$500k/yr.
-Coordinated all CMC activities (managing the CTD project) to file the NDA
for the company's new drug product .
-Responsible for reorganizing the development/manufacturing/supply chain
groups in Milan, Italy and Seattle,
Washington.
-Responsible for a $40MM operating budget.
Director Global Supply Chain, Solvay Pharmaceuticals (Amsterdam,NL) 2002 -
2004
Responsible for the $2B supply chain activities for the global
pharmaceutical sector. Responsibilities included, supply chain
improvement, purchasing, customer service, logistics and managing 3rd party
business (>$450MM).
Accomplishments
-Implemented a global S&OP system that eliminated out of stock situations
in all major countries in the less than 18
months (>E23MM).
-Responsible for the rationalization of the E26MM warehousing and logistics
activities for European operations.
-Led implementation of a global forecasting, ordering and inventory control
system based on SAP's APO/SNP.
General Manager, Solvay Pharmaceuticals (Baudette, MN) 1999-2002
Brought on board to manage the firms US manufacturing site that was under
an FDA AIP. Responsibilities included production, engineering, human
resource, purchasing, logistics, validation, QC and IS activities for a
multi-facility production site producing >$600MM product/yr.
Accomplishments
-Managed an annual operational budget of $12MM; a capital projects budget
of $13.2MM
-Facilitated budget reductions of ~5%.
-Reduced backorders by nearly $10MM culminating in a no-backorder status.
-Spearheaded staffing redeployment to introduce a 'flatter' operations
group.
-Identified and corrected $11.2MM budget overruns of facility construction
projects.
Director of Operations, Sonus Pharmaceuticals, (Bothell, WA.), 1997- 1999
-Responsible for all supply chain, manufacturing, engineering and facility
related activities for bio-pharm company in late phase III clinical trials.
Responsibilities included; process development, scale up and preparation
for commercialization for APIs, excipients and parenteral products.
Accomplishments
-Managed CRO and CMO for clinical supplies.
-Coordinated scale-up activities with partner for mid-size and commercial
scale process.
-Managed project to convert manufacturing process from terminal sterile
filtration to aseptic process within 9 months
-Implemented a new computerized inventory control system, budget tracking
system and the installation of a
corporate computer network and a corporate computer based security system.
-Managed the construction of a new research laboratory wing and a new pilot
plant.
-Developed corporate strategy to ensure uninterrupted supply of key raw
materials.
KEVIN C, MIODONSKI (cont.)
Procyte Corporation, (Kirkland, WA.), 1993-1997
PLANT MANAGER Responsible for all activities to bring a start-up
pharmaceutical manufacturing operation and a medical device manufacturing
facility from concept to a validated operational facility. I was
responsible for the conceptual design, permitting and construction of the
new facilities. I coordinated the scale-up and tech transfer of a complex
API from pilot scale to commercial scale manufacturing in the new facility.
I identified the requisite commercial scale equipment, established the
equipment maintenance and calibration programs, identified raw material
vendors, and was responsible for the production of acceptable
pharmaceutical products in the facility. Additionally I was responsible
for all engineering activities as well as all facilities related issues in
the 50,000 sq. ft facility. Later I was responsible for business
development including, developing strategic plans, identifying and
developing contract business and business negotiations.
Accomplishments
-Generated contract business in excess of $2.1MM in the first year.
-Facility received a no 483 during its first FDA GMP inspection
Additional Experience
Production Supervisor/Manager, Burroughs Wellcome Co. (Greenville, NC),
1988-1993
Bulk Manufacturing Manager, The Mentholatum Company (Buffalo, NY), 1986-
1988
Technical Manager/Quality Control, Chemtronics Inc. (Hauppauge, NY), 1985-
1986
EDUCATION:
DUKE UNIVERSITY: Masters, Business Administration 1993.
STATE UNIVERSITY COLLEGE AT BUFFALO: B.S. Chemistry, 1984.
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