EDUCATION:
| B.S. |
The
College of William and Mary, Williamsburg, VA, Biology
(1989) |
EXPERIENCE:
CURRENT
POSITION: |
|
Vice
President Finance, Secretary,
Treasurer, Biologics Consulting Group, Inc. |
| Jan.
2003 to present |
|
Serve
as accounts receivable/payable
Organize
monthly invoicing to clients
Organize
technology coordination throughout company
Oversee
web site maintenance
|
| |
|
|
| Jan.
1994 - Dec. 2002 |
|
Director
of Quality Assurance, Biologics Consulting Group, L.L.C.
- Reviewed
and developed Documentation Systems for biological
manufacturing facilities (SOPs, BPRs, cleaning records,
etc).
- Reviewed
Quality Control documentation (environmental monitoring,
assay validation, training records, change control,
etc.)
- Manager
of Information Services
- Webmaster
- Office
Manager
|
| |
|
|
| Sept.
1993- Dec. 1993 |
|
Biologist,
GS-12, Laboratory Immunobiochemistry, Division of
Allergenic Products and Parasitology, Office of Vaccine
Research and Review, CBER/FDA |
| |
|
- Certified
CBER Inspector.
- Review
protocols, release of products, confirmatory testing,
and review of product license applications and IND
submissions.
- Write
and edit SOP's for use in the laboratory.
- Research
and development of assays for possible regulatory
implementation.
- Membership
on PLA review committees.
- Assist
in training of new personnel.
- Skills:
- Working
knowledge of DOS, UNIX and Macintosh computer
systems.
- Perform
various laboratory techniques (ELISA, radioimmunodiffusion,
isoelectric focusing, immunoblotting, ninhydrin
protein assays and radioallergosorbent tests [RAST])
for the testing of products in support of license
applications.
|
| |
|
|
| Mar.
1992 - Sept. 1993 |
|
Biologist,
GS-11, Laboratory of Allergy and Immunochemistry,
Division of Bacterial Products, Office of Biologics Research,
CBER/FDA |
| |
|
- Participated
in a variety of research projects to isolate and characterize
biochemically and pharmacologically active components
of Allergenic Products by physical, chemical, and
immunological methods.
- Provided
technical guidance and training of subordinate personnel
and others assigned to the Center for instruction.
- Scheduled
experiments in consultation with supervisor, recorded
results of laboratory tests, performed necessary calculations
and wrote preliminary drafts of reports. Furnished
detailed data for manuscripts.
- Presented
at scientific seminars.
- Certified
CBER Inspector.
- Served
on committees to determine the eligibility of applicants
for establishment and product licenses.
- Reviewed,
evaluated and made recommendations for approval or
rejection of product and establishment license applications
and amendments.
|
| |
|
|
| July
1990 - Mar. 1992 |
|
Biologist,
GS-9, Laboratory of Allergenic Products, Division
of Bacterial Products, Office of Biologics Research, CBER/FDA |
| |
|
- Writing/editing
of test procedures for laboratory use.
- Performance
of specific bioassays, enzyme assays and immunochemical
assays on a routine basis as part of research or control
related experimentation.
- Performance
of protein separations and characterizations using
biochemical and physiochemical techniques.
- Performance
of electrophoresis methods such as Iso-Electric Focusing
and SDS-PAGE.
- Performance
of preparative IEF and analysis of fractions by HPLC.
|
| |
|
|
| June
1989 - July 1990 |
|
Biologist,
GS-7, Laboratory of Allergenic Products, Division
of Bacterial Products, Office of Biologics Research, CBER/FDA |
| |
|
- Writing/editing
of test procedures for laboratory use.
- Electrophoretic
methods (Polyacrylamide and agarose gel electrophoresis
and Isoelectric Focusing).
- Formulation
and preparation of laboratory reagents and buffers.
- Chemical
assays such as ninhydrin assay to measure protein
content of allergenic extracts and spectrophotometric
determination of protein.
- Immunological
assays such as immunoblotting, radio-immune assays
and autoradiography.
- Single
antigen assays for Antigen E and Cat Allergen I using
immunodiffusion techniques.
- Use
of Macintosh software for data analysis.
|
PROFESSIONAL
SOCIETIES:
- Regulatory
Affairs Professional Society (RAPS)
- Parenteral
Drug Association (PDA)
- Drug
Information Association (DIA)
CONTINUING
EDUCATION:
| 2002 |
|
VaBIO
Summit and Governor's Conference 2002, October 2002,
McLean, VA. |
| 2002 |
|
RAPS
Annual Conference 2002, October 2002, Washington,
DC. |
| 2002 |
|
Quickbooks
Workshop |
| 2001 |
|
VaBio
Biotechnology Summit and Governor's Conference 2001,
October 2001, Washington, DC. |
| 2001 |
|
RAPS
Annual Conference 2001, October 2001, Baltimore,
MD. |
| 2000 |
|
Essentials
of US Regulatory Affairs Webcast Series, Modules
1-4 (July 2000) |
| 1999 |
|
Essentials
of US Regulatory Affairs Webcast Series, Modules
1-4 (July 1999) |
| 1999 |
|
PhRMA/FDA
Error and Accident Reporting; PhRMA Workshop, Washington, DC |
| 1998 |
|
Workshop
on Electronic Submissions of Biologics; DIA course, Washington, DC |
| 1997 |
|
Capture
Your Share of the Vaccine Market; The
Institute for International Research (IIR),
Washington, DC |
| 1997 |
|
Pharmaceutical
Document Management: Moving Beyond Paper in a Global
Environment; DIA course, Philadelphia, PA |
| 1996 |
|
Regulation
of Biologics; Center for Continuous Education, Alexandria,
VA |
| 1996 |
|
Assay
Validation; PDA Educational Course Series, Baltimore,
MD |
| 1992,
93 |
|
Inspection
Workshop; FDA training, Bethesda, MD |
| 1991 |
|
Biologics
Update '91; FDLI course |
| 1990-92 |
|
Annual
Educational Conferences; FDLI |
| 1990 |
|
Biological
Law Seminar, Inspection Training; FDA training,
Bethesda, MD |
| 1990 |
|
Basic
Hazard Communication Training Course; FDA training,
Bethesda, MD |
| 1990 |
|
Advertising
& Promotion of Biologics; FDLI course |
| 1990 |
|
Basic
Principles of Immunology & Hypersensitivity;
Graduate Program at NIH Foundation for Advanced
Education in the Sciences (FAES), Bethesda, MD |
| 1989 |
|
Radiation
Safety; NIH Training, Bethesda, MD |
HONORS
AND AWARDS:
| May
28, 1993 |
|
FDA
Group Recognition Award - Member of the Allergenic
Products Licensing Group for Cat Allergens |
| 1992-1993 |
|
Student
and Teacher Internship Program - Certificate
of Appreciation in Recognition of the many hours
of teaching and support as a preceptor in the
Student and Teacher Internship Program sponsored
by The Howard Hughes Medical Institute, Montgomery
County Public Schools and the National Institutes
of Health |
| May
31, 1991 |
|
FDA
Group Recognition Award - Member of Allergenic
Products Licensing Group |
CERTIFICATIONS:
| Nov.
6, 1999 |
Regulatory
Affairs Certified (RAC) - expired 2002 |
| May
24, 1993 |
FDA
Certified Regulatory Inspector of Licensed Manufacturers
of Biologic Products. |
|
REGULATORY
PRESENTATIONS & PUBLICATIONS:
| 1. |
Anderson,
MC; Boyle, KT; Seymour, AB; Matthews, JL; Turkeltaub,
PC. 1991. In-vitro and in-vivo Evaluation of Cat Extracts.
FDA Sigma XI Poster Science Exhibition. |
| 2. |
Anderson,
MC; Boyle, KT; Seymour, AB; Turkeltaub, PC. 1991. Characterization
of Cat Extracts. FDA Sigma XI Poster Science Exhibition. |
| 3. |
Matthews,
JL; Turkeltaub, PC; Anderson, MC; Boyle, KT. 1991. The
Assignment of Biological Allergy Units to Standardized
Grass Extracts. J. Allergy Clin. Immuno. 87:1, p 186. |
| 4. |
Anderson,
MC; Boyle, KT; Seymour, AB; Turkeltaub, PC. 1991. Stability
of Cat Extracts. J. Allergy Clin. Immuno. 87:1, p
178. |
| 5. |
Boyle,
KT; Anderson, MC; Turkeltaub, PC. 1991. Characterization
of Cat Extracts: Beyond Fel d I. J. Allergy Clin.
Immuno. 87:1, p 178. |
| 6. |
Anderson,
MC; Boyle, KT; Kenimer, JG. 1992. Characterization
of Cat Extracts with IsoElectric Focusing (IEF). J.
Allergy Clin. Immuno. 89:1, p 152. |
| 7. |
Boyle,
KT; Anderson, MC; Kenimer, JG. 1992. Specific IgE to
Latex Extracts. J. Allergy Clin. Immuno. 89:1, p 224. |
Page
Updated:
June 16, 2008
|
