VP, Manufacturing Fill/Finish
United Therapeutics Corp
1040 Spring Street
Silver Spring, MD 20910
I believe with my background in aseptic processing I can make a positive contribution to the group and assist with growing the influence of the organization. .
19 years of experience in the pharmaceutical industry with Genentech, Cardinal Health (fka ALP), RxElite and United Therapeutics with 16 of those years having direct involvement with BFS manufacturing.
- Extensive background in product development, validation, and regulatory affairs.
- Direct experience with multiple governmental regulatory bodies including, but not limited to, FDA, MHRA, EMEA, HPB (Canada), TGA (Australia) and AFSSAPS (France).
- Author or Co-Author of 8 published technical articles, 4 of which were peer reviewed, that relate to BFS technology and its use in aseptic packaging of drug products.
- Named inventor on 3 international drug delivery design/use patents, two of which are still pending.
- Frequent technical speaker on BFS technology with PDA, ISPE and other professional organizations.
- Current member of the ISPE Sterile Products Community of Practice Board.
- Former technical officer for the BFS IOA.
- Familiar with both Weiler Engineering and Rommelag BFS equipment.
In addition I am in close proximity to both FDA and PDA which could be leveraged to the benefit of the BFS IOA