Senior Consultant, Biologics Consulting Group, Inc., Raleigh, NC.

Senior Manager, Process Engineering, Biolex Therapeutics, Inc., Pittsboro, NC

• Managed internal efforts, as well as, outside consultants to ensure timelines during process development, conceptual design and process scale-up engineering studies are met.
  
• Responsible for managing US$1.1 million process engineering budget.
  
• Established laboratory for the evaluation of novel manufacturing platforms.
  
• Developed equipment prototypes suitable for cGMP production from conceptual design to testing.
  
• Played both, a hands-on and leadership role during these projects.
  
• Successfully led team during conceptual design, detail design, construction and testing of novel system in record times.
  
• Developed operational/growth cycles, as well as, sequence of operations for sanitization/cleaning using cutting edge technology (chlorine dioxide).
  
• Developed process operational conditions for novel manufacturing platforms suitable for large scale manufacturing processes.
  
• Led fast track process optimization efforts, screened major factors for impact in yield, final titers and process cycle time.
  
• Provided leadership during conceptual planning for a pilot facility start-up, process scale-up and validation.
  
• Responsible for process simulation projects that integrated process development, scale-up and facility design. Led team that identified key process steps for reductions in cycle time and cost of goods, as well as, minimization of capital costs.

Drug Substance Validation Manager, Integrated Commissioning Validation Group, Jacobs Engineering, Wyeth Pharmaceuticals, Grange Castle, Clondalkin Ireland.

• Recruited and organized personnel to staff validation department (50 reports) during start-up phase.
  
• Developed validation protocol templates, testing approach and technical content for process equipment in a 12,500-L scale Cell Culture commercial manufacturing plant.
  
• Supported start-up commissioning efforts.
  
• Led validation activities such as troubleshooting, protocol generation, deviation resolution, post-execution protocol review, change control, final report generation to ensure timelines were met.
  

Associate Director, Technical Services, Diosynth RTP (Formerly Covance Biotechnology Services, Inc.), Research Triangle Park, NC .

• Responsible for training, coaching and development plans for direct reports (10 reports, combination of engineers, scientists and operators, various educational levels).
  
• Oversaw direct reports during tech transfer, production campaign start-up and lot release efforts.
  
• Supported lot release efforts, performed post-execution batch record technical reviews.
  
• Investigated process deviations, coordinated assessment of product impact, review/write-up of technical memos as required.
  
• Supported Pre-Approval Inspection (PAI) company wide readiness initiatives.
  
• Participated in intra-departmental discussions to establish best practices for product life cycle (from development, to clinical phase and through approval).
  

• Coordinated cell culture project in order to successfully meet aggressive deadlines under a cGMP environment.
  
• Led team responsible for commissioning, equipment qualification and technology transfer for upstream operations in record time (six months).
  
• Involved in validation protocol write-up and review, schedule development, process and equipment troubleshooting.
  
• Responsible for communicating project results, providing updates and making recommendations to senior management and clients.
  
• Recruited and organized personnel to adequately staff cell culture manufacturing department (21 operators, supervisors).
  
• Responsible for cGMP production campaigns at the 2000-L scale, batch records and standard operating procedures review.

Manager, Fermentation Development Scientist, Diosynth RTP, Research Triangle Park, NC .

• Recognition award for contributions to the company's success:"Covance Way" Award (top 1% performers).
  
• Coordinated fermentation efforts in order to successfully meet aggressive project deadlines.
  
• Responsible for cGMP production campaigns. Supervised personnel (5 reports), set-up schedules, ordered cGMP production materials, wrote batch records, raw material specifications and standard operating procedures.
  
• Collaborated with QC, QA, EM, Document Control and Manufacturing departments to ensure an efficient product turnaround.
  
• Responsible for process development studies. Designed and conducted experiments to improve final product titers and increase process robustness.
  
• Scaled-up process changes from 15-L to 140-L.
  
• Responsible for communicating results to project team members and clients.

Senior Research Associate, Diosynth RTP, Research Triangle Park, NC .

• Conducted studies for the optimization of bacterial fermentation processes (15-L scale). Experiments resulted in increased product concentration.
  
• Conducted process optimization studies (15-L) and cGMP yeast fermentations (140-L scale).
  
• Conducted medium optimization studies to increase product titers in mammalian fed-batch cultures (spinner flasks and 15-L bioreactors).
  
• Adapted mammalian cells to suspended cultures under serum free conditions.
  
• Actively involved in technology transfers from process development to manufacturing.

Research Assistant, Northwestern University, Evanston, Illinois

• Studied acetone production /acetic acid removal in aerobic fermentations as a mechanism for in-situ removal of toxic metabolic side-products (fermentors, spinner flasks, GC analysis, SDS-PAGE, anaerobic chambers).
  
• Introduced heterologous metabolic pathways into E. coli. Performed DNA manipulations to construct DNA vectors (electroporation, restrictions enzyme analysis, DNA blots, agarose gels etc.).
  

Analytical Chemist, Eli Lilly and Company, Shadeland, IN.

• Developed and evaluated (linearity, precision, stability, resolution, robustness, specificity, accuracy) analytical methods utilized in process optimization and scale-up of new pharmaceutical products (synthetic molecules).
  
• Transferred analytical methods to QC laboratories.
  
• Provided analytical support to production and pilot plant operations.
  
• Developed expertise in troubleshooting HPLC and GC equipment, FT-IR spectrophotometer.

• International Society of Professional Engineers (ISPE)
• Healthcare Businesswoman Association (HBA)
  

TRAINING (SELECTED COURSES)

• 2006 - Separation and Purification Strategies for Biotechnology Products.
  Pennsylvania State University.
  
• 2005 - Six Sigma: Total Quality Applications. Wake Technical Community College.
  
• 2003 - Manufacturing Control Software, DeltaV Systems. Commissioning Overview. Emerson Process Management.
  
• 2002 - JMP Software: Statistical Data Exploration. SAS Institute.
  

HONORS

• "Covance Way Award" (top 1% performers) (1999)
  
• Illinois State Biotechnology Program Grant (1993)
  
• National Science Foundation Scholarship (1993)
  
• Walter P Murphy Foundation Fellowship (1992)
  
• Dean's List (1988 - 1985)
  

PATENTS:

• Method for producing and purifying Angiostatin. 6,723,536. Issued April 20, 2004

PUBLICATIONS:

• Fermentation Process Development and Scale up for Recombinant Production in Pichia pastoris. ACS 219th National Meeting, Mar. 26-30, 2000.
  
• Expression of Clostridium acetobutylicum ATCC824 genes in Escherichia coli for acetone production and acetate detoxification. 1998, Appl. Environ. Microbiol. 64(3) 1079-1085.
  

Page Updated: June 16, 2008