Management Project

JAMES M. ESSELSTYN

*** ********* **** ****** *******, WASHINGTON 98115

e-mail: ************@*****.*** telephone 206-***-****

PROFILE

Management professional with extensive experience in the pharmaceutical industry. Proven ability to promote productive collaboration within and outside of corporation. Responsible for high volume production and packaging of components for internationally marketed, FDA approved, diagnostic kits. Avid and capable manager of schedules and projects.

PROFESSIONAL ACCOMPLISHMENTS

Production Supervisor III overseeing two departments for the compounding and filling of reagents to be used in FDA licensed blood virus diagnostic kits

Participation in the Materials Review Board investigating and resolving Non-Conformance Reports and Deviation Reports

Determination of requirement for NCR/DR by consultation with staff about a required or mistaken situation involved in GMP manufacturing

Training in and experience with the transition of laboratories to the Kaizen method of organization

Wide ranging experience with research laboratory techniques involving: Cell Biology, Tissue Culture, Assay Development, Protein Chemistry, Immunology and Molecular Biology

PROFESSIONAL EXPERIENCE

BIO-RAD LABORATORIES, Redmond, Washington

2007-Present

Production Supervisor III

Laboratory management of a GLP laboratory generating production

scale amounts of purified and/or conjugated antibodies and bulk compounding

for diagnostic kit components. Method and material support for

Research & Development.

Concurrent management of a GMP facility performing filling and labeling of kit

components for blood virus diagnostics

Participation in the generation and resolution of Non-Compliance and Deviation

reports

Support of inspections by FDA, TUV and audits by external customers

Monitoring of tasks and determination of sufficient quality and quantity of work

Bi-annual review of staff for yearly evaluation and tracking of development goals

Hiring, promotion, discipline and termination of employees

ICOS CORPORATION, Bothell, Washington 1998-2007

Technical Scientist

Cell Biology, Molecular Biology, Phage Display Antibody Generation, Hybridoma

Generation, Immunochemistry, Immunofluorescent Staining, Methods Development and Assay Development for the investigation of experimental therapeutics for the treatment of Obesity, Urological Disorders and Cancer.

Performed PDE enzyme expression profiles using western blot for a wide variety of

tissues in humans, monkeys, rats, dogs, guinea pigs and an assortment of cell

lines.

Generated and expressed active phosphodiesterase enzymes using yeast.

Extensive cell culture experience.

oPrimary culture, differentiation and utilization of human and monkey cells

oSecondary culture, growth and use of a broad selection of immortal cell lines

Routinely performed western blot, northern blot, immunoprecipitation, coomassie and

silver stain.

Established and maintained contacts for the acquisition of difficult to acquire tissue for

primary culture. Designed and executed experiments with this tissue.

Chaired the ICOS Safety Committee. Chaired meetings, developed agenda, circulated

meeting notes for committee feedback, archived minutes after the committee

vote of approval. Facilitated communication between ICOS Safety Committee

and the ICOS Legal Department

Regularly presented experimental progress for departmental meetings.

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BRISTOL-MYERS SQUIBB, Seattle, Washington 1989-1997

Research Scientist

Cell Biology/Immunology

Molecular Biology

Protein Chemistry

UNIVERSITY OF WASHINGTON, Seattle, Washington 1987-1989

Research Technologist

Antibody generation, cloning, purification, FITC, PE and biotin conjugation

Small animal surgery

FACS assays and FACS machine maintenance

GREAT NOTION FOREST MANAGEMENT, Eugene, Oregon

1981-1987

Corporate Treasurer and forest worker

Managed Corporate Books, issued paychecks, paid bills and interacted with CPA

Managed contracts and acted as interface between company and contracting

organization

Planted and thinned trees as a member of a high production team

EDUCATION and TRAINING

Oregon State University, Corvallis Oregon,

Bachelor of Science, Microbiology

Certificate Program in Project Management

University of Washington, Seattle Washington

Certificate of Achievement, Project Management

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