Quality Control Medical Device

James W. Christian

*G Bayberry Road

Acton, MA 01720

*********@*****.***

508-***-****

Education

****-**** *.*. ********** Science / Biotechnology Option Magna Cum Laude

University of Massachusetts Lowell

Professional Experience

2002-2005 Research Development

Shire TKT Cambridge, MA

Formulation Development of Elaprase (idursulfase) TM, Stability Stress Testing and Analysis of Recombinant Proteins.

Duties Included Assisting in Stability Study Design, Coordination, Testing, Documentation, Data Analysis, Presentation

and Report Writing. Including: HPLC (SEC, IEX, RP), Peptide Mapping, SDS PAGE, IEF, Western Blots, Dynamic Light

Scattering, Spectroscopy and Activity Assays.

Obtained research recognition on US Patent Number 8,545,837 B2 Titled Methods and Compositions for CNS Delivery of Iduronate-

2-Sulfatase. A method of treating Hunter Syndrome comprising a step of administering intrathecally to a human subject in need of

treatment a formulation comprising an iduronate-2-sulfatase (I2S) protein at a concentration at or greater than 5 mg/mL at a dose of

at least 10 mg. June 25, 2011. (US Patent office)

2001-2002 Quality Control Analyst II

Stryker Biotech Hopkinton, MA

Quality Control Testing of OP-1 ImplantTM, in cGMP Environment. Testing, Documentation, Data Analysis and Review,

Equipment Validation. Including: ELISA, Spectrophotometry, Environmental Monitoring, Appearance Testing.

OP-1 Putty – H020008 is approved as a Medical Device under Humanitarian Device Exemption (HDE) Program approved on April

7, 2014. Used to make posterolateral spinal fusions. It is manufactured from genetically engineered human protein, bovine collagen

matrix and sterile saline solution. (FDA Website Medical Devices)

1998-2001 Research Associate

Formatech Andover, MA

Formulation Development, Stability Testing and Analysis of Proteins, Peptides and Small Molecules. Including:

Researching IV and Oral Formulations, Stability Indicating Assays, Product Lyophillization, HPLC (SEC, RP), SDS

PAGE, IEF, Spectrophotometry, Fluorescence Spectroscopy, Activity Assays. Laboratory Safety Officer.

1995-1996 Geology Department Equipment Technician

Earth Tech Concord, MA

Maintained, Rented and Tracked Environmental Monitoring Vehicles and Equipment. Light Field Work Included: Soil

Sampling, Instrument and Sample Delivery.

Recent Non-Science Related Work Experience

2012-2014 Mechanic Auto Repairs

Sawyer Automotive Acton, MA

2011-2012 SkiLift Attendent

Wachusett Mountain Princeton, MA

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