Project Manager Engineer

KRISTY PYSCZYNSKI

** ***** **** ******

Elkton, MD 21921 ***********@*******.*** 302-***-**** (C)

SUMMARY

A Chemical Engineer and Biochemist with a strong background in research, design and new product

development, in a manufacturing and research environment. Team facilitator, with demonstrated

flexibility to manage multiple business needs. Ability to interact with all associates across business units

and functions. A proven ability to self-lead as well as to lead others. Patent, “Slip Resistant Multi-layered

Articles”.

Design of Experiments (DOE) Analysis of Variance (ANOVA)

Process & Performance Optimization

Statistical Process

Control (SPC)

Project Management

Cell and Molecular

Biology

Techniques

Solid Technical Background

Green Belt Six

Sigma

PROFESSIONAL EXPERIENCE

Synthes, West Chester, 2007- 2010

Synthes is a leading global medical device company. Through its five business units (Trauma, Spine, Cranio-

Maxillofacial, Biomaterials and Power Tools), Synthes develops, produces and markets instruments, implants and

biomaterials for the surgical fixation, correction and regeneration of the human skeleton and its soft tissues. The

company generates annual sales surpassing$3.2 billion and employs 10,000 people worldwide.

Process Development Engineer, Project Manager

Responsible for the $1,500,000 construction of a new facility from the acquisition of a lease to a finished

facility creating Class 10,000 and Class 100,000 cleanrooms and development lab space. Assembled a

process for manufacturing a biological implant which included defining the specifications of equipment,

sourcing equipment, purchasing equipment, coordinating lead times and delivery. Validated equipment

(IQ, OQ, PQ). Designed and executed experiments to improve the $3,000,000 transferred process

purchased from an outside company to build a validated process through to commercialization with a

volume of 4000 pieces/month. Hired and trained operators for current process and hired scientist for next

generation product line. Wrote SOP’s and Raw material specifications.

Technical skills: Validation, designing experiments, statistical analysis using Statgraphics and minitab,

project management, process specification, SOP preparation, material and equipment specification, green

belt six sigma training

Terumo Medical Corporation, Elkton, MD 2005- 2007

Terumo has distinguished itself as a high quality manufacturer of medical products from superior quality needles and

syringes to innovative blood oxygenators.. The company generates annual sales surpassing $1.5 billion and employs

7,500 people worldwide.

Project Engineer

Validated the removal of a process step in printing syringe barrels improving output and work

environment. Improved shelfpack design for customer to include tamperproof and product identification.

Developed and validated a robust process window and specifications for sealing current allergy tray

product. Moved chemical solution preparation to allow for cost savings and chemical control. Validated

a resin change that impacted every product in the interventional product lines. Validated a new 30G 1cc

Insulin Syringe product that completed the Insulin Syringe Product line up through 30G. The IS syringe

lines make 250 parts/min. 100,000 parts/shift with 3 shifts/day. Developed new procedures and modified

existing process procedures.

Technical skills: Designing experiments, statistical analysis using Statistica, project management,

process specification, Design History Files for FDA requirements and SOP preparation

KRISTY PYSCZYNSKI

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***********@*******.*** 302-***-**** (C)

W.L. GORE AND ASSOCIATES, Elkton, MD 2001-2005

Comprised of approximately 6,000 associates in 45 locations around the world. Annual revenues top $1.8 billion .

Fluoropolymer products provide innovative solutions throughout industry, in next-generation electronics, for medical

products, and with high-performance fabrics.

Product Development Engineer

Collaborated with manufacturing, sales, and technical legs to drive new product developments through

commercialization. Drove testing on raw materials to provide translation between the process issues and the

polymer properties of interest. Used statistical analysis tools and design of experiments to establish robust

process windows. Created robust process window for a product that captured the Canadian Military business

and profited $1MM from the product. Improved process windows for our largest textile product, saving a yield

loss of over $1MM/year.

Technical skills: Designing experiments, statistical analysis using SAS and JMP, project management,

knowledge in the following laboratory equipment: Brookfield viscometer, Capillary rheometer, Scanning

Vibrating Needle Curemeter.

RENSSELAER POLYTECHNIC INSTITUTE, Troy, NY 1999-2001

Provides graduate, undergraduate, and postgraduate education and research programs, primarily in the sciences.

Rensselaer has its main campus in Troy, New York, but also has two other campuses in the cities of Hartford and

Groton in Connecticut.

Research Technician in Enzymology

Researched, designed, and performed a variety of experiments including the acryloylation of PVDF

membrane and cross-linking with HEMA to form hydrogel layer used for antifouling.

Modification of starch with a variety of enzymes to form hydrogels. Enzymatically synthesized sucrose

1’ acrylate. Prepared biocatalytic silicates by modifying, chymotrypsin and cross-linking with a silane

monomer to form the subsequent polymer. Gene evolution using mutagenic PCR.

Technical skills: Flash, thin-layer, gas, and size-exclusion chromatography, testing membrane flux,

testing for antifouling properties of the biocatalytic silicate using spectofluormeter, and testing for

enzyme activity as well as concentration using spectrophotometer.

ALBANY MEDICAL COLLEGE, Albany, NY 1998-1999

One of the nation’s first private medical schools. Other members of the organization include the Albany Medical

Center Faculty Group Practice, staffed by about 350 full-time clinical faculty members of the medical college.

Laboratory Manager/ Research Technician in Endocrinology

Managed laboratory operations such as ordering supplies, inventory, preparing media, autoclaving

glassware, maintaining cell lines, and performing monthly isotope swipes. Researched, designed, and

performed experiments using orbital fibroblasts from patients with and without Grave’s Disease.

Technical skills: Passing orbital fibroblasts and endothelial cells, treatment and harvesting of cells for

protein and RNA content, GAG assays using tritium, RNA extraction from human tissue, SDS-PAGE,

western and northern blots, and follicular cell extraction from thyroid tissue.

KRISTY PYSCZYNSKI

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NEW YORK STATE HEALTH DEPARTMENT, Albany, NY 1997-1998

Research Technician in Virology

Conducted basic laboratory duties such as ordering supplies, preparing media, and making plasmid

preparations. Researched, designed, and performed experiments with the oriLyt replicating region of

HCMV.

Technical skills: Cloning, sequencing DNA, passing Hff cells, infecting and harvesting SF9 cells,

mapping nuclease P1 sites, restriction mapping, and gel electrophoresis. 5’ end labeling oligos, primer

extensions preparing large volumes of plasmid DNA for experiments, footprinting, and RT-PCR

EDUCATION

Rensselaer Polytechnic Institute, Troy, NY

- Master’s of Engineering, May 2001

- Major: Chemical Engineering

University at Albany, State University of New York

- Bachelor of Science, May 1997

- Major: Biochemistry and Molecular Biology

- Minor: Spanish

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