Experience

Cell Sciences, Inc.
• United States
• Biotechnology Research
• 1 - 100 Employee
• Technical Support Scientist

  • 2018 - Present


CPEX Pharmaceutical Company

• Biotechnology Research
• 1 - 100 Employee

• Consulting Scientist

  • 2015 - 2018

  Analytical review of Methods, Clinical and Preclinical data to support business development. Analytical review of Methods, Clinical and Preclinical data to support business development.



Millennium Research Laboratories, Inc.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director of QA/QC

  • 2012 - 2015

  Transfer and Validation of Analytical Methods from pharma clients to MRL testing laboratories. Review of SOP, stability and release documents for CRO. Transfer and Validation of Analytical Methods from pharma clients to MRL testing laboratories. Review of SOP, stability and release documents for CRO.

• Principal Scientist

  • 2008 - 2011

  Developed analytical methods for Preclinical & Product Development. Investigation of peptides & proteins as potential drugs & vaccines, for nasal and intradermal delivery, using a proprietary permeation enhancer CPE-215. Regulatory support for CMC sections on nasal insulin, Nasulin. Technical transfer to CROs, audit of preclinical testing facilities. Developed analytical methods for Preclinical & Product Development. Investigation of peptides & proteins as potential drugs & vaccines, for nasal and intradermal delivery, using a proprietary permeation enhancer CPE-215. Regulatory support for CMC sections on nasal insulin, Nasulin. Technical transfer to CROs, audit of preclinical testing facilities.



Sanofi Genzyme

• Associate Director for QC Diagnostic Products & Reagents

  • 1995 - 2000

  Responsible for 21 lab personnel in two groups: Diagnostic Kits & Enzyme Reagents. Validation, Stability and Technical Support for cytokine ELISA kits. Method transfer and support for Manufacturing. Represent QC for Marketing and Business Development. Responsible for 21 lab personnel in two groups: Diagnostic Kits & Enzyme Reagents. Validation, Stability and Technical Support for cytokine ELISA kits. Method transfer and support for Manufacturing. Represent QC for Marketing and Business Development.



Pfizer

• Events Services
• 1 - 100 Employee

• Group Head QC Bioassay

  • 1992 - 1995

  Responsible for 10 laboratory staff performing bioassay and ELISA for IL-2, IL-12, BMP-2, FVIII, FIX, GM-CSF, bulk and drug product. Potency and stability determination for clinical and R&D products. Assay validation, raw material testing, mycoplasma, endotoxin, viral assays, cell banks. Responsible for 10 laboratory staff performing bioassay and ELISA for IL-2, IL-12, BMP-2, FVIII, FIX, GM-CSF, bulk and drug product. Potency and stability determination for clinical and R&D products. Assay validation, raw material testing, mycoplasma, endotoxin, viral assays, cell banks.



Biogen

• South Africa
• Wellness and Fitness Services
• 1 - 100 Employee

• Manager QC Bioassay

  • 1983 - 1986

  Responsible for 8 laboratory staff performing bioassays and ELISA for IFN-a, IFN-g, IL-2, TNF, to support manufacturing, stability and clinical drug supply. Validation of ELISA for IL-2 to replace KIT bioassay for potency. Developed ELISA methods for R&D with subsequent technical transfer and validation for QC use. Responsible for 8 laboratory staff performing bioassays and ELISA for IFN-a, IFN-g, IL-2, TNF, to support manufacturing, stability and clinical drug supply. Validation of ELISA for IL-2 to replace KIT bioassay for potency. Developed ELISA methods for R&D with subsequent technical transfer and validation for QC use.


Atlantic Antibodies, Inc.
• Product Development Scientist

  • 1981 - 1983