Project Manager Manufacturing

KURT PHINNEY

** ****** ****** . ****, ************* 02045

********@*****.*** . 781-***-**** h . 781-***-**** c

Experienced Manufacturing and Project Manager with demonstrated success and

a proven track record implementing current process improvement trends, Six

Sigma, Kaizen, TOC, and Lean Manufacturing to optimize product yield,

quality, and reliability in assay, device, and sterile fill manufacturing.

Ready to take on Project Management tasks associated with the Research,

Development, Technology Transfer, Production, and pre & post sales support

in the biomedical industry.

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Consultant, Biotechnology

ICA Consultants

Biomedical Project Manager (November 2008 - Present)

Assist with the design and implementation of procedures, documentation

(DHR, QC, IID, and IQOQPQ SOPs), and technical transfer from development

into GMP manufacturing environments. Projects include preparation of

products for FDA approval, Government grant procurement and fulfillment,

microbiology, and cell culture.

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Nova Biomedical, Waltham, MA

World technology leader in clinical, cell culture, and contract

manufacturing of biomedical products.

Sr. Project Specialist (September 2007 - October 2008)

Interacting with clients and internal staff to develop a robust and user-

friendly biomedical product optimized for individual customer needs,

training, world wide sales, and support. Through telephone, email, on-

line, and on-site contact with North American clients acting as a liaison

between Product Development, customers, and field support staff, this

position integrated the lines of communication and supported major

developments in product design and use. Additionally, managing and leading

training seminars (in-house and on-site) designed to educate varying

degrees of BioMedical background and technical knowledge on the scientific

and laboratory aspects of the BioProfile analyzer line, bioreactors,

sterile manufacturing, and laboratory integration systems. The result was

a greater than 30 fold increase in product placement coupled with consumer

loyalty.

. Designed bioreactor laboratories using the latest product and process

trends, following current government regulations and regulatory

requirements. Assisted clients in improving the upstream and

downstream work flow using the latest trends in bioreactor and cell

culture technology.

. Developed the company's OPC software in a cooperative agreement with

an outside vendor. Coupled with leading the applications install and

support plan for Nova's OPC software, this allowed Nova's analyzer to

integrate with LIMS and data control systems for some of the largest

production laboratories in the United States.

. Led the Applications division to develop strategic planning for the

support and training of our biotechnology products worldwide.

. Created IQ & OQ documentation and procedures used in the validation of

the capital equipment and implemented these procedures in the field

insuring following US, Canadian, and the client's internal

regulations.

. Traveled extensively to insure customer satisfaction, to train on the

latest bioreactor related products, and provide executive

accountability overseeing regional Field Service representatives.

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Immunetics Incorporated, Boston, MA

An infectious disease assay development and manufacturing company,

Immunetics researches and produces both esoteric and high-volume diagnostic

test kits for use in laboratories throughout the world.

Manufacturing Manager, Project Manager (February 2003 - August 2008)

Following FDA and EU regulations, managed a staff of manufacturing

technicians and development scientists to insure the highest quality, most

efficient production of goods. Experience with TOC intermixed with GMP

guidelines and ISO standards were used to continually improve the

manufacturability of all biological, chemical, and hardware goods under my

direction. Interaction with Sales insured products were built according to

demand, weekly status reports were presented to the CEO and VP, frequent

communication with R&D to insure new products were transferred to following

our guidelines, along with active participation in all management meetings

was imperative for the success of Manufacturing.

. Implemented Lean Manufacturing leading to a reduction in cost of

goods, improved product yield and increased efficiency of manufacture

for the company's diagnostic and research-use-only products.

. Served as the Project Manager and Lead Scientist guiding the

development of HIV, Lyme, and other confidential products, serving as

the Product Manager for their release.

. Lead the development of an HIV product based on my previous generation

HIV product (see below), which was awarded an exclusive contract to

provide Gates Foundation testing in Africa.

. Balance long and short-term goals to meet customer demand while

maintaining inventory at efficient levels.

. Served as internal Project Manager for the design and build-out of a

new manufacturing laboratory. This included review and contracting of

an architect, reviewing designs and layouts, working with the General

Contractor, and procuring new laboratory equipment. On-budget and on-

time completion allowed manufacturing to proceed on track and without

delay.

. Developed protocols and sourced gear to create a sterile fill and

manufacturing environment.

. Improved the yield of the company's bio-assay products by greater than

70%, lowering the cost of, manufacturing and improving the turn-around

time.

. Demonstrably improved the quality of the company's HIV, Lyme, and

Anthrax products by introducing new quality checkpoints and enhancing

the methods of manufacture. Customer issues decreased from 10-20

weekly to 12 annually in the second year and 11 in the third year.

. Design and implementation of new approaches to streamline workflow,

further reducing the cost of ELISA manufacture to less than 10% of the

product revenue.

. Implemented inventory tracking and device history tracking software to

insure more accurate and timely access to project and manufacturing

metrics.?

Associate Scientist, Assay Development and Project Manager, Hardware

Development (July 2003 - February 2004)

A multi-faceted position tasked with creating an FDA approvable HIV Western

Blot, product transfer into Manufacturing, improving the chemical

manufacturing processes, and developing a new hardware product, the

MiniBlotter.

. Completed the R&D improvement of the company's HIV product 18 months

ahead of schedule and assisted with the transfer into Manufacturing

resulting in increased revenue for the company ahead of plan.

. Investigated design improvements on the company's leading hardware

product, and created a new design, which is journal recognized as

superior to all previously existing designs.

. Co-developed ELISA and Western Blot assays using monoclonal and

polyclonal antibodies for use in IVD and RUO production. Later

transferring these assays into production and affecting further

improvements assisted in company-wide growth.

. Building on research I began at the State Lab Institute, continued

researching methods of collecting samples and developing assays for

infectious disease use in 3rd World communities.

. Co-authored two patents on a new hardware design to assist clinical

and research Western Blot and protein assay accuracy and throughput.

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State Laboratory Institute of Massachusetts, Jamaica Plain, MA

Tasked with providing rapid response capability to support infectious and

environmental disease outbreak investigations, laboratory data for

surveillance and diagnosis to aid disease prevention, and active response

to biologic and chemical terrorism events the State Lab Institute is the

Commonwealth's chief resource in improving the public health.

Bacteriologist ( March 2001-June 2003)

Working under a CDC grant, co-developed an HIV avidity assay capable of

detecting sero-positive patients and estimating the approximate time of

infection, thereby assisting in the management of infection as well as

aiding in the identification of possible infected partners. Cultivated and

maintained contacts with health care and scientific professions worldwide.

. Developed an HIV-1 avidity assay for presentation to health care

providers worldwide.

. Assisted in the designed of a new Anthrax and SARS testing facilities

following the public health crisis in 2001 and 2003, respectively,

allowing the lab teams to quickly respond to the public need.

. Devised experiments to determine the effects of storage conditions on

serum and oral fluid with respect to how these conditions may affect

the reliability of ELISA assays.

. Applied storage research to investigate methods later used to develop

assays usable in third-world communities.

. Created new procedures for conducting complex testing: including EIA,

Western blot, and PCR to increase the throughput of the State's

testing methods.

. Integrated laboratory equipment and computer systems to work with LIMS

software to reduce the workload of, and transcription errors by,

laboratory staff.

. Modified commercially available laboratory equipment and software for

use in experimental procedures designed to improve the quality of

testing in private and Public Health laboratories.

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Additional experience as Laboratory Coordinator with Quest Diagnostics

(Brookline Village, MA) and Health Service Corpsman with US Coast Guard

(including certification and training as an Independent Duty Corpsman and

out-patient and emergency Dental Technician.) A full synopsis is available

on request.

Education and Certifications

B.S., Biology State University of New York at Albany,

June 1999 Albany, N.Y.

A.S., Chemistry Hudson Valley Community College, June

1997 Troy, N.Y.

Corpsman Training USCG Health Service Corps,

February 1993 Petaluma, CA

OPC Levels 1, 2, & 3 (2008 version) certified programmer and technician.

February, 2008 Houston, TX

"Train The Trainer" certificate program for public speaking and customer

training. November 2007 Waltham, MA

Patents, Awards, Presentations, Merits, and Professional Societies

. Founder and moderator of "Laboratory Automation for Cell Growth and

Fermentation." An online community forum with over 90 members from

some of the most renowned Biotechnology and Pharmaceutical firms

worldwide.

. USPTO Patent Application 200********: Chemistry, Molecular Biology And

Microbiology Binding Assay Device.

. Modification of a Commercial HIV-1 Enzyme Immunoassay for

Identification of Recent HIV-1 Infections: Use of Differential

Antibody Avidity. Presented at the Conference on Retroviruses and

Opportunistic Infections.

. Awarded Outstanding Achievement Medal for managing the first USCG lab

to achieve CLIA certification.

. Awarded Unit Commendation Medal (Operation Desert Storm)

. Awarded National Defense Service Medal (Operation Desert Shield/Desert

Storm)

. Awarded Humanitarian Service Medal (Life saving operations in the

Baring Sea)

. Awarded Good Conduct Medal (2)

. Awarded Meritorious Team Commendation Medal.

. Volunteer worker for the Hull Lifesaving Museum.

. Volunteer worker for the Maritime Apprentice Program working with

children in the custody of the Department of Youth Services.

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