EXPERIENCE:

Advanced Barrier Concepts Europe – Gieres, France
(2004 – Present)

Manager of European Operations: Expand the services of Advanced Barrier Concepts into the European market for the design and qualification of isolator based projects in the areas of containment, sterility testing and advanced aseptic manufacturing of sterile products. The following is a listing of selected current and past projects:

1. Clinique La Prairie: Montreux, Switzerland – Conceptual Design and Qualification of an Isolated Aseptic Filling Line (2005 – Current)
2. Wyeth: Hsinchu, Taiwan. Qualification of an Isolated Sterility Testing Suite (2006)
3. Centocor: the Netherlands - Qualification of an Isolated Sterility Testing Suite (2005)
4. Sanofi Pasteur: Swiftwater, PA – Revalidation Isolated Production Aseptic Filling Line (2005)
5. Mayne Pharma: Mulgrave, Australia - Qualification Isolated Sterility Testing Suite (2004)
6. Janssen-Cilag: Puebal, Mexico – Qualification and Revalidation of an Isolated Sterility Testing Suite (2004 and 2005)

Advanced Barrier Concepts – Cary, North Carolina, North Carolina
(2000 - 2003)

Project Scientist: Provided direct technical assistance to the pharmaceutical and biotechnology industries regarding the decontamination process, environmental monitoring requirements, and validation requirements for sterile isolator applications. Project activities included sterility testing, clinical manufacturing, sterile bulk packaging and high-speed production filling operations. Responsibilities included validation planning, protocol generation / execution, preparation of final reports, and regulatory facility inspection support.

Merck Sharp and Dohme Chibret – Clermont-Ferrand, France  
(1997 – 2000)

Validation Engineer: Validation of a STERIS VHP1000 decontamination process for production isolators and soft wall lab isolators for a large-scale integrated vial filling and lyophilization line, which utilized automatic loading/unloading for the freeze dryers and isolated capping and inspection systems.

University of Oklahoma - Norman, Oklahoma 
(1996)

Student Researcher: Laboratory of Neurochemistry. Worked with the Alzheimer’s disease detecting the product of the enzymatic reaction of the L-aminoacid Decarboxylase on an aberrant metabolite of the serotonin using HPLC methods. In vitro and In vivo experimental work.

EDUCATION:

Institut Universitaire Professionalisé (IUP), School of Pharmacy, Montpellier, France. Diplôme de Recherche Technologique (DRT) in Health Engineering, specialization in analytical chemistry. The DRT is equivalent to a Master of Science. 1999

Institut Universitaire Professionalisé (IUP), School of Pharmacy, Montpellier, France. Maîtrise in Health Engineering, major in analytical chemistry and bioanalytical reactions. The Maîtrise is equivalent to a Bachelor of Science. 1996

PROFESSIONAL AFFILIATIONS:

International Society for Pharmaceutical Engineering (ISPE)
Parenteral Drug Association (PDA)