KATHERINE COLAGROSSO

***** ***** **. ****: 720-***-****

Westminster, CO 80021 Email: advw7m@r.postjobfree.com

PROFESSIONAL EXPERIENCE

TerumoBCT Lakewood, Colorado August 2007-February 2023

Senior Scientific Lead Product Development

Closely involved in all aspects of two large-scale medical device systems for feasibility and medical release developed in research and development.

The senior scientist to work the longest duration on the medical Reveos Whole Blood Automated Device from feasibility, release and implementation specifically on the.

oLead the analysis and reviewed reports on the 510k submission for the device.

oLead the feasibility and release of the device in the EU.

oHosted and the main lead for two weekly meetings for the entire systems team with a summary of data analysis results and updated notes with the meeting minutes.

oWorked directly with supervisors, engineers and scientists to determine direction of testing for each week to continually optimize the system performance and reliability.

oLed and implemented a lab in India to conduct TerumoBCT testing.

Involved in the approval on three abstracts approved by AABB in 2022.

Involved in verifications for multiple Reveos projects

oWrote verification protocols, executed the protocol, entered the data, analyzed data and wrote the reports for approval.

Visited and led the implementation of the medical device in over eight countries and multiple US States.

oDemonstrating the device and value to the staff, doctors and CEOs.

oTraining the production staff to the device.

oTroubleshooting the device at the site with training and data analysis.

Created data sheets and spreadsheets to record data that are used by the staff on a regular basis.

Developed a data system to automate data analysis. This includes, but not limited to Mini-Tab 21, Excel, pivot tables, data models and Prism.

Involved in every laboratory practice including but not limited to performing experiments, obtaining samples from many different blood products, entering data and analyzing results on a daily basis.

oGained knowledge in different aspects of my field to help with the project such as engineering mechanics, flow cytometry, plasma free hemoglobin analysis, cell counting, morphology, disposable integrity, regulatory and marketing.

oTrained co-scientists on the device upon hire.

Gained knowledge on important factors involved in successful performance of similar medical devices and applied it to the creation of our own device.

Attended AABB conference in Montreal to demonstrate a newly released CaridianBCT product.

Received excellent reviews on performance for review.

LANCASTER LABS AT AMGEN Boulder, Colorado August 2006-Department lay off August 2007

Analytical Chemist

Performed analysis in a GMP environment of pharmaceutical waters, CIP (clean-in-place), COP (clean-out-of-place) and in-process protein samples from manufacturing facilities.

oAnalytical techniques include pH, conductivity, determination of total or non-purgeable organic carbon, kinetic and gel clot Limulus Amebocyte Lysate test for endotoxin detection, UV absorbance, protein concentration determined by UV absorbance and nitrate testing.

oFollowed USP testing, Standard Operating Procedures and Analytical methods with a high degree of accuracy and precision.

oTesting STAT samples, approved results within 2-4 hours of receipt.

Gained approver status of analytical techniques performed by other analysts in notebooks and LIMS database.

Received two hero-maker awards and recognition for client focus, teamwork and collaboration, work standards, initiative and service excellence.

COLLEGE PHARMACY Colorado Springs, Colorado April 2005 – August 2006

Compounding Pharmacy Technician

Implemented and managed the distribution and production of the Dermacell skin care product line.

oLed process development and devised proprietary compounding methods to improve consistency and effectiveness of both topical gels and powder while working closely with pharmacists and company founder.

oDirectly contributed to increased sales of Dermacell by creating an extract file sufficient to satisfy up to 70 orders daily.

Compounded individualized prescriptions not available commercially using formulas and raw chemicals; these prescriptions can be specific to a patient’s needs in terms of strength, flavor or nutritional content (e.g., preservative-free, sugarless).

oSpecialty area is creams, solutions and suspensions; other formulations include nasal sprays, sublingual tablets, suppositories and troches. Prescriptions for a wide variety of ailments are compounded daily including, but not limited to GI medications, skin care, thyroid medications, heart medications, hormone replacement therapy and autism medication.

Developed a wide range of knowledge on the properties of numerous chemical compounds as well as commercially available medications; became familiar with therapeutic uses, off-label uses, side-effects and contraindications of these medications.

Received an award of excellence based on ability to adapt, learn quickly, maintaining a positive attitude and improving processes at College Pharmacy.

Received an outstanding review after six months of employment.

EDUCATION

UNIVERSITY OF COLORADO AT COLORADO SPRINGS Colorado Springs, Colorado

Emphasis in Nursing

UNIVERSITY OF COLORADO AT BOULDER Boulder, Colorado

Bachelor of Science in Environmental, Population and Organism Biology

RED ROCKS COMMUNITY COLLEGE

EMT-B License and Nursing Pre-requisites

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