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Engineer Manufacturing

Location:
Cary, NC
Posted:
October 06, 2013

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Resume:

Sarah Bianco

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

Apex, NC ***02

617-***-****• ab9ynb@r.postjobfree.com

Biochemist with significant clinical trial and flow cytometry experience.

PROFESSIONAL EXPERIENCE:

Cell Manufacturing Engineer

Aldagen

May 2012 – September 2013

• Responsible for manufacturing human cellular product to be transplanted in human stroke patients.

• Responsible for maintaining, operating, and troubleshooting a customized BD Aria cell sorter in a clean room.

• Responsible for producing customized tubing sets to use for clinical trial processes.

• Responsible for developing, implementing, and editing clinical documentation used in the manufacturing

process.

• Responsible for following cGMP guidelines and aseptic technique during a human process in a clean room

environment.

• Responsible for developing new ideas to help streamline and ensure a quality human product was being

released.

• Responsible for developing, testing, and implementing changes in a release criteria assay.

• Responsible for gathering and interpreting data and results.

• Responsible for significant testing of materials and methods to better the manufacturing process.

• Significant experience with clinical documentation and batch records.

Flow Cytometry Research Specialist

University of North Carolina at Chapel Hill

August 2011 – May 2012 Chapel Hill, North Carolina

• Responsible for operating a five laser Sony iCyt Reflection.

• Responsible for performing human sorts in a BSL2+ environment working with HIV, HEP-C, LCMV, etc.

• Responsible for start-up, shut-down, QC and maintenance on the Reflection.

• Responsible for maintenance and QC of three Beckman Coulter Cyan Analyzers.

• Responsible for meeting with customers and assisting in experimental design.

• Responsible for assisting customers in running flow cytometry samples as well as analyzing past flow cytometry

data.

• Responsible for running QC and assisting users with experimental runs and conducting user trainings on BD

LSRII.

Flow Cytometry Resource Technician

Beth Israel Deaconess Medical Center/ Harvard Stem Cell Institute

March 2010 – August 2011 Greater Boston Area

• Experienced user on Aria, Astrios, MoFlo XDP, Gallios, LSRII, Celigo, and FACScan.

• Experienced user on analysis software such as Kaluza and FlowJo.

• Responsible for conducting user trainings for analyzers and sorters.

• Responsible for performing facility assisted analysis on multiple analyzers.

• Responsible for consulting users on experimental design (fluorochrome choices, set-up, cell preparation, etc.).

EDUCATIONAL QUALIFICATIONS:

North Carolina State University

BACHELOR OF SCIENCE, BIOCHEMISTRY

2005 – 2009

COURSES COMPLETED:

• Biochemistry of Gene Expression, Proteins and Molecular Mechanisms, Macromolecular Structure,

Macromolecular Synthesis and Regulation.

Continued Education

Wake Tech BioNetwork, Capstone Center

2012

Elements of Aseptic Manufacturing

PROFESSIONAL AWARDS AND PRESENTATIONS:

Cyntellect Travel Award Program.

• Receipt of the Cyntellect award based on abstract and poster submission (In Situ Cytometry as a

Viable Technology in a Flow Core) for ISAC May 2011.

Presented poster at ISAC May 2011.

• In Situ Cytometry as a Viable Technology in a Flow Core.

Presented at ISAC May 2011 in Baltimore, Maryland.

• Presented on the QA and QC procedures of Flow Cytometry.

Presented at IFCC/ESCCA BC Flow Cytometry Course in Leipzig, Germany.

• Presented on sorting hematopoietic stem cells on a Beckman Coulter Astrios and doing further

analysis using Kaluza.

References available upon request



Contact this candidate