Neal Biomedical Engineer

11/29/2014
Hamilton, NJ

Position Desired

Biomedical Engineering
Anywhere in the U.S.
Yes

Resume

EDUCATION
Rutgers University, School of Engineering, Piscataway,NJ May 2011
Bachelor of Science in Biomedical Engineering
Cumulative GPA: 3.47/4.0, Major GPA: 3.78/4.0

PUBLICATIONS
Aran, K, Fok, A, Sasso, L.A, Kamdar, N, Yulong Guan, Q, S, Ündar, A, & Zahn, J.D. (2011). Microfiltration platform for continuous blood plasma protein extraction from whole blood during cardiac surgery. Lab on a Chip, 11(17), 2858-2868. DOI: 10.1039/C1LC20080A

Aran, K, Sasso, L.A, Kamdar, N, & Zahn, J.D. (2010). Irreversible, direct bonding of nanoporous polymer membranes to PDMS or glass microdevices. Lab on a Chip, 10(5), 548-552. DOI: 10.1039/B924816A

EXPERIENCE
Johnson & Johnson Group of Consumer Companies, Skillman, NJ
Scientist II- Technical Assurance May 2011- Present
-Manage multiple high impact business continuity projects for raw material qualifications to prevent disruption in commercial production of marketed consumer products.
-Completed several high priority business continuity crisis projects and met the deadlines to avoid substantial customer service and sales impact for high volume products (up to and over $24MM sales annually).
-Initiate and complete Change Controls to update raw material/ product process specifications and batch records for formulated Cosmetic, OTC Drug, and Class II Medical Device products.
-Lead investigations for non-conformances with Quality Assurance to determine root cause and implement Corrective and Preventive Actions (CAPA).
-Direct regional and international conference calls with business partners and raw material suppliers to communicate project plans, deliverables, and timelines. Publish meeting minutes.
-Write technical reports, justifications, risk assessments, and protocols to support Non-Conformance's, raw material supplier qualifications, and compliance driven changes.
-Supported the development and implementation of IQ/OQ/PQ validations for manufacturing equipment in a commercial manufacturing plant to support a CAPA.
-Develop laboratory and pilot scale batches of finished products to perform stability studies. Travel to external and internal manufacturing sites to supervise scale up production of marketed finished products.
-Collaborate with Quality Assurance, Regulatory Affairs, Product Development, Microbiology, Toxicology, Analytical, and Clinical Safety/ Claims groups.
-Gather and present quarterly metrics for business continuity projects in the Raw Material Center.
-Adherence to SOPs, QSPs, cGDP, cGLP, cGMP, and EH&S in an FDA regulated environment to ensure that safety and quality compliance is maintained in all aspects of the business.

Rutgers University BioMEMS Laboratory, Piscataway, NJ
Undergraduate Researcher May 2009 - May 2011
-Assisted in the development of a microfluidic blood plasma extraction device to be used for continuous monitoring of inflammatory biomarkers in patients undergoing cardiac surgery.
-Supported Graduate research by helping to analyze the device performance in a clinical lab setting using a simulated cardiopulmonary bypass (CPB) system and in-vivo testing during a piglet model of extracorporeal life support (ECLS) at the Penn State Hershey Medical Center.
-Developed a novel bonding method to obtain a leakage free bond between porous polymer membranes and microfluidic devices by chemically modifying the membrane surface.
-Designed and fabricated polymer microfluidic devices via AutoCAD, photolithography, soft lithography, SU...

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