Medical Device Years Experience

Kate Karaaslan

**** ***** **. #**** • Toronto, ON, Canada M2N 7G8

647-***-**** • *************@*****.***

SUMMARY

A Research & Development Chemist specializing in formulations. A hands-on product developer, who enjoys benchtop development and experimentation with different ingredients, techniques and product forms

PROFILE

• 2+ years experience as an R&D Chemist for a medical device company.

• Bachelor of Science in Chemistry

• Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods

• Create chemical solutions for products, following standardized formula methods and experimental formulas

• Develop, improve, and customize formulas, processes and analytical methods

• Direct, coordinate, and advise personnel in test procedures for analyzing components and physical properties of materials

• Write technical reports, prepare graphs/charts to document experimental results

• Proficient with MS Project, Microsoft Word, Excel and PowerPoint, Chemstation, QuickBooks, Adobe Acrobat

• Highly motivated self-starter, strong ability to work in teams and collaborate, flexible, excellent problem solving skills and exceptional verbal and written communications skill, work efficiently under pressure

WORK EXPERIENCE

R&D Chemist

Gordion Diagnostic, Ankara, Turkey (2007-2009)

• Formulated and developed in-vitro diagnostic kits which consists of buffers and reagents

• Provided created formulations data to support RA team to ensure successful product submission.

• Develop robust product development work plans

• Prepared and reviewed analytical results to ensure compliance with GMPs.

• Experienced with HPLC, ELISA, UV/Vis spectrophotometer

• Prepared, reviewed SOP, validation and stability documents.

• Reviewed/participated in stability protocol.

• Trained new employees on laboratory procedures, GMPs.

• Established, developed and validated analytical testing methods, calibrating and troubleshooting, tested equipment, interpreted chromatograms and reported scientific results to support regulatory submissions

• Ability to troubleshoot equipment such as HPLC

EDUCATION/CERTIFICATION

Bachelors of Science: Chemistry, Celal Bayar University, Manisa, Turkey (2007)

Post Graduate Diploma of Pharmaceutical Regulatory Affairs Program, Academy of Applied Pharmaceutical Sciences (AAPS), Toronto, ON (2010)

PROFESSIONAL DEVELOPMENT

• Auditing Certification, APPS (2010)

• HACCP and GMP Program in Food Industry Certification, AAPS (2010)

• Advanced High Pressure Liquid Chromatography Certification, AAPS(2010)

• High Pressure Liquid Chromatography Certification, Gordion Diagnostic, Ankara, Turkey (2008)

REFERENCES AVAILABLE UPON REQUEST

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