Quality Control Method Development Scientist

CHRISTINA CLARK

Ledyard, CT *****

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

Cell 860-***-****

PROFILE

Quality Control Analyst and Method Development Scientist with 14 years of lab bench experience in the biotechnology industry. Possesses comprehensive knowledge in method development and process improvement with a penchant for detail. Proactive in problem solving which results in superior products from PCR, DNA sequencing, library preparation and other molecular techniques. Maintains sound scientific lab practices in accordance with ISO 9001 standards. Supports GMP principles, 5S and other Lean Six Sigma practices. Applies a scientific approach contributing to a positive and progressive lab environment.

TECHNICAL SKILLS / INSTRUMENT PROFICIENCIES

Pyrosequencing

PCR

Library Preparation

Flow Cytometry

pH

UV/Vis

Gel Electrophoresis

Restriction Digest

Cloning

Fluorescent Tag

Microsoft Word, Excel, Power Point

LIMS

SAP

454 Sequencing Systems

Beckman Coulter Counter 3

Agilent Bio-Analyzer

BioTek Synergy MX Luminometer

Accuri Flow Cytometer

HIAC 9705

PROFESSIONAL EXPERIENCE & KEY ACCOMPLISHMENTS

HoffmannLa Roche/454 Life Science, Branford, CT 2003 - 2015

Roche, a Swiss based pharmaceutical company that focuses on developing innovative medicines and diagnostic tests.

Held several Quality and Methods Development positions in manufacturing operations always focused on strengthening the Roche standards of excellence ensuring consistent quality products and results.

Senior Quality Control Analyst (2014-2015)

Designed and implemented experimental studies on sequencing polymerase attributes. Authored report and academic paper and presented findings to colleagues.

Supported Manufacturing, Customer Support and Quality Assurance departments on the resolution of complaints, discrepancies and Out of Specifications (OOS) investigations.

Participated in Material Review Board investigations and root cause analysis of non-conforming products in conjunction with the Corrective and Preventive Actions (CAPA) system.

Supported standard QC testing of raw materials, process intermediates and finished products.

Maintained and calibrated QC equipment in accordance to ISO 9001 regulations.

Senior Method Development Associate (2013-2014)

Attained required resources, performed sequencing runs and compiled data for DOE (Design of Experiments) for product launch of a new sequencing platform.

Supported stability studies for new buffer formulations to be used on 454’s sequencing platform.

Qualified/verified key oil components in order to improve small volume emulsion PCR platform.

Completed qualification of enzyme beads in process improvement project for reagent manufacturing.

Method Development Analyst III (2011-2013)

Assisted in developing analytical method to replace functional testing of PCR enriching kit.

Developed method for counting sub-micron beads on the flow cytometer using fluorescent tag.

Developed and wrote SOP for new sub-micron bead counting method and assisted with verification report.

Validated new PCR bead that increased consistency of end product.

Created Accuri C6 flow cytometer maintenance protocol and troubleshoot resulting runs.

Quality Control Analyst III (2010-2011)

Instrumental in developing biotin binding assay. Performed enrichment bead biotin binding titration studies and suggested proper range of streptavidin concentration on enrichment beads.

Developed an assay to measure submicron beads percent solids via filtration process.

Suggested an alternate approach to filtering sequencing reagents which once implemented saved 45 minutes of set up time per run.

Quality Control Analyst II (2008-2010)

Conducted PPi tolerance study to determine maximum allowable PPi concentration in reagents.

Explored and evaluated various instruments for purchase that measured characteristics of sub-micron beads. Performed sub-micron bead count study on Beckman Coulter Counter 3.

Assisted in transferring quality control PCR and library preparation protocols to new platforms.

Conducted routine and non-routine analysis of reagents. Maintained and calibrated QC instruments.

Research Associate II (2003-2008)

Worked in all aspects of 454 pyrosequencing: Library preparation, emulsion PCR, sequencing runs, analyzing data, performing QC at every step within the protocols. Organized and maintained new lab.

Supported research and development by performing experiments designed for process improvement.

Curagen Corporation, Branford, CT 2000 - 2002

Curagen, a genomic-based pharmaceutical company acquired by Celldex Therapeutics, Inc.

Achieved superior results from molecular assays expeditiously and right first time.

Research Associate II (2001-2002)

Isolated plasmids with inserts via Qiagen mini, maxi, and giga preparation.

Assisted and trained colleagues in generating expression databases through restriction digest, PCR, pooling, fractionation, elution, ligation, transformation and plating.

Research Associate I (2000-2001)

Prepared samples of DNA via filtration process for sequencing on Megabase instruments.

EDUCATION

M.S. Cell and Molecular Biology, University of New Haven, West Haven, CT May 2015

Mini MBA Bio Pharmaceutical, Rutgers University, New Brunswick, NJ 2014

B.S. Microbiology, University of Massachusetts, Amherst, MA 2000

CERTIFICATES

Practical HPLC & UHPLC Basics, Equipment and Troubleshooting

Lean Six Sigma Yellow Belt

DQM Design of Experiment Training

AMA’s Business Writing Workshop

Introduction to FTIR

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