
Consultant/Teacher - Microbiology, Environmental Monitoring, Sterility Assurance, Contamination Control, QC, cGMP.
Rochester, New York Area

Consultant/Teacher - Microbiology, Environmental Monitoring, Sterility Assurance, Contamination Control, QC, cGMP.
Rochester, New York Area
I have over 20 years of laboratory leadership experience in the microbiology arena of the pharmaceutical, medical device, cosmetics and personal products industries with extensive publications and presentations. Contamination control, laboratory management, training, GMP, testing methodologies and microbiology-related project management are areas of special interest. Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses.
I also operate an information source on the internet, The Microbiology Network (http://www.microbiol.org) which provides services to microbiology-related user’s groups and supports the PMFList, a microbiology Email list (http://www.microbiol.org/pmflist.htm) and the PSDG Email list (pharmaceutical stability topics) (http://www.microbiol.org/psdglist.htm).
View a more complete resume at http://www.microbiol.org/consulting.htm.
In-house Courses (save training budget) in GMP, Contamination Control and Laboratory Topics
Manufacturing Support:
- Aseptic processing
- Environmental/process monitoring
- Objectionable Organisms
- Process Control of Bioburden
Investigations
Microbiology Lab Operations:
- Laboratory Audits
- Data review and evaluation
- Laboratory Design
- Rapid microbiological methods (RMM)
Quality Operations
Project Management
Expert Witness
(Pharmaceuticals industry)
June 2009 — Present (6 months)
Responsible for a column on "Microbiology Topics" in each issue of these quarterly journals.
(Privately Held; 11-50 employees; Pharmaceuticals industry)
March 2004 — Present (5 years 9 months)
Aseptic Processing, Environmental Monitoring, Laboratory management, training, GMP, Quality Assurance, testing methodologies and microbiology-related project management are areas of special interest.
(Non-Profit; 1-10 employees; Pharmaceuticals industry)
January 2002 — Present (7 years 11 months)
The PMF was created to provide a forum for microbiologists in the pharmaceutical, medical device and personal products industries to exchange information on microbiological issues and to provide an opportunity to interact with regulatory agencies internationally.
The PMF produces and publishes the PMF Newsletter. This publication is based on information, articles, questions and answers contributed by the members and is available online. The PMF also sponsors a public mail list with The Microbiology Network. The PMFList is devoted to topics of interest to microbiologists working in the pharmaceutical, cosmetics, and medical device industries and is distributed via Email over the Internet.
(Pharmaceuticals industry)
1994 — Present (15 years )
This site is provided as a resource for the microbiologist in regulated industries. The Microbiology Network serves as a communication resource for the microbiology and biotechnology communities serving pharmaceutical, medical device and personal products industries.
(Pharmaceuticals industry)
1993 — Present (16 years )
I have had the honor of participating in work of the United States Pharmacopeia committee on Microbiology (through several name changes) since 1993. This volunteer activity has been among the most rewarding of my career.
(Public Company; 10,001 or more employees; ACL; Pharmaceuticals industry)
June 1994 — March 2004 (9 years 10 months)
(Public Company; 10,001 or more employees; BOL; Medical Devices industry)
September 1988 — June 1994 (5 years 10 months)
Ph.D. , Microbiology , 1983 — 1987
M.S. , Microbiology , 1981 — 1983
B.S. , Genetics , 1974 — 1978
microbiology, writing, RC airplanes, camping, fishing, science fiction, reading
PMF, USP, ISPE, PDA
2008 PDA Distinguished Author Award for "Pharmaceutical Quality Control Microbiology - A Guidebook to the Basics"