PROCESS ENGINEER
FOCUS: DEVELOPMENT & IMPROVEMENT OF PROCESSES | AREA: BIOTECHNOLOGY /
PHARMACEUTICAL INDUSTRY

QUALIFICATION PROFILE

Highly skilled chemical engineer with 4.5-years process and cleaning validation
experience. Over a year's experience in the design, scale-up, and operation of
manual and automated filtration equipment. Successfully led multiple projects on
multiple unit operations. Proven ability in leading and supporting
cross-functional teams in project execution and process troubleshooting. Strong
background in fermentation and purification equipment, and a SME in
chromatography operation. Highly familiar with historical and current process
analysis for identifying process parameters and providing requirements for
updating current process equipment. Strong knowledge of cGMP principles.
Developed hands-on skills with bench-scale protein analysis and cell culture
background during research studies. Extremely effective in stressful situations.

EDUCATION

Master of Science in Chemical Engineering, North Carolina State University
-Raleigh, NC: Aug 2003
Bachelor of Science in Chemical Engineering, Virginia Polytechnic Institute &
State University -Blacksburg, VA: May 2001 (magna cum laude)

AREAS OF EXPERTISE

 * Fermentation & Purification Equipment Knowledge
 * Leadership, Time Management & Prioritizing
 * SME of Chromatography Operation
 * Hardworking & Detail-oriented
 * Process Support & Troubleshooting
 * Oral & Written Communication
 * Equipment Qualification Review & cGMP Knowledge
 * Strong Analytical Abilities
 * Process Data Analysis
 * Micro / Ultrafiltration Process & Equipment Design
 * Multi-tasking team player within a fast-paced setting

PROFESSIONAL EXPERIENCE

SMARTFLOW TECHNOLOGIES (FORMERLY NCSRT, INC.) - APEX, NC: SEPT. 2008 - PRESENT

 * Initial customer contact in designing appropriate process and equipment for
customer-specific applications, including cell culture harvest or protein
separation / concentration.
 * Complete and review applicable P&ID drawings for customer requested systems.
 * Work with project engineering to define system requirements for customer
applications, including URS, FDS, and DDS review.
 * Developed and performed bench scale UF and MF testing of varying customer
supplied starting materials. Prepared technical reports based on in-process data
analysis from filtration runs.
 * Coordinated long term testing plan for NF testing of yeast hydrolysate,
including documentation and customer support.
 * Coordinate with customers for on-site demonstrations, including test
development, equipment design, and coordination with system and filter shop.
 * Customer liaison for FAT testing of automated filtration skids. Prepare and
perform FAT testing.
 * Act as technical support on module installation, performance, and
qualification for key customers in biotechnology / pharmaceutical industry.
 * Created instruction manual for newly designed filter module.

TALECRIS BIOTHERAPEUTICS - CLAYTON, NC: SEPT. 2005 - SEPT. 2008
VALIDATION SPECIALIST II: JAN. 2008 - SEPT. 2008
 * Led cross-functional team to evaluate improvements to current cleaning
validation methodology.
 * Lead engineer for process revalidation evaluating and identifying critical
process parameters and quality attributes. Led cross-functional project team to
complete characterization testing and validation execution, including schedule /
timeline development and coordination.
 * Lead validation engineer for the qualification and validation of new gel
filtration column train and liquid chromatography skid. Developed and maintained
schedule / timeline of validation activities, coordinated activities with
engineering, quality, regulatory, technology, and technical operations.
 * Prepared IQ/OQ, CV, PV, and ETP protocols for new gel filtration column train
and liquid chromatography skid, executed IQ protocols for column train and skid,
and assisted in execution of OQ protocols for column train.
 * Managed developmental testing and analysis for new gel filtration column
train and liquid chromatography skid.
VALIDATION SPECIALIST: OCT 2006-JAN 2008
 * Led cleaning validation of two processing tanks.
 * Kicked-off implementation of new buffer mixing vessel with identification of
parameters and processing / validation requirements.
 * Led process and cleaning validation of spare gel filtration chromatography
column. Planned new process validation quality attribute acceptance criteria
based on current and historical processing capability.
 * Wrote and implemented new Chromatography Validation SOP. Performed
departmental training for initiation of SOP.
 * Prepared investigation reports for executed protocols.
VALIDATION ENGINEER II: SEP 2005-OCT 2006
 * Lead validation engineer for process validation and mixing qualification
scale-up. Coordinated activities, developed mixing acceptance criteria, executed
mixing qualification, compiled data, and prepared final reports.
 * Developed and executed bench scale testing method to determine column buffer
behavior in spectrophotometer and worked with cross-functional team to identify
cause of cleaning validation deviation.
 * Cross-functional team lead on investigation involving chromatography percent
recovery deviation. Performed historical and current process review and data
collection.
 * Successfully managed the re-qualification activities on Bulk Pasteurizer as
well as the cleaning validation of four processing tanks in Purification area.
WYETH VACCINES -SANFORD, NC: MAR 2004-SEP 2005
VALIDATION ENGINEER II
 * Led cross-functional teams to find root causes and corrective actions for
process, cleaning, and equipment validation deviations in fermentation /
purification area.
 * Designed process requirements for the scale-up of ion exchange chromatography
column including FRS, URS, FAT, packing methodology, and validation criteria.
 * Evaluated qualified status of equipment based on maintenance, calibration,
process parameters, and instrumentation reviews.
 * Prepared regulatory submission document with data analysis for release
specification change.
 * Performed statistical analysis to define new release specifications and
in-process controls.
 * Compiled, organized, and performed statistical comparison of in-process data
to support product hold times.
 * Reviewed manufacturing production records to ensure accuracy of process
parameters in fermentation and purification.

OTHER EXPERIENCE

PRIVATE MATH / SCIENCE TUTOR AND SAT PREPARATION TEACHER MASTERMIND PREP
-RALEIGH, NC: 2003-2004
GRADUATE RESEARCH (CHEMICAL ENGINEERING DEPT) NORTH CAROLINA STATE UNIVERSITY
-RALEIGH, NC: 2002-2003
UNDERGRADUATE RESEARCH (CHEMICAL ENGINEERING DEPT) VIRGINIA TECH -BLACKSBURG,
VA: 1998-2001

Professional Development

Effective Presentation Skills, APLS Group: June 2008
Fundamentals of Project Management, Interactive Consulting Services, Inc.: May
2008
Fundamentals of Management for Non-Managers, CAI, Inc.: May 2007
Team Based Project Management, Lewis Institute, Inc. in North Carolina State
University: Apr 2005
Writing Effective Procedures and Technical Report Writing, IWCC Program: Sep
2004
Engineer-In-Training: Jun 2001

LABORATORY SKILLS

 * Process development for new systems: cell implantation in alginate hydrogels,
fluorescent labeling of cells for viability testing in alginate gel, immunoassay
for verification of protein production in alginate hydrogel, and a vertical
diffusion chamber system
 * SDS-PAGE, DNA gels, Western blots, ion exchange and size exclusion
chromatography, spectroscopy
 * Fluorescent confocal microscopy
 * Mammalian cell culture, sterility testing, BCA protein assay, ELISA assay

KEY ACHIEVEMENTS

GAANN Biotechnology Fellowship: 2001-2003
Honorable Mention, National Science Foundation Graduate Research Fellowship:
2002
First Place AIChE National Student Paper Competition, Chondrocyte-alginate
Hydrogel Research: 2001
Publication
"Design and Application of an Oscillatory Compression Device for Cell
Constructs," Biotechnology and Bioengineering. Cassino, T.R., Anderson, R., Love,
B.J., Huckle, W.R., Seamans, D.K. and Forsten-Williams, K. Volume 98, Issue 1,
September 1, 2007. Pages 211-220.