Carl Wilson:
President, CEO
International
BioPharmaceutical
Consulting, Inc.
|
PROFESSIONAL QUALIFICATIONS
Fifteen years industrial
training in the areas of Quality Assurance and Quality Control program
development for manufacturers of medical devices, diagnostics, small molecule
oral dosage forms and sterile injectable preparations of monoclonal antibodies,
peptides and carbohydrates. Experience includes analytical chemistry,
microbiology, validation and auditing, as well as development of policies
and systems for ISO, QSR and cGMP compliance.
EDUCATION
BA Biology, MA Microbiology,
California State University, Fullerton.
CONSULTING EXPERIENCE
- Development
of raw material qualification programs.
- Analytical
laboratory design and facility start–up.
- Validation
of HPLC methods for assessing the identity, potency and purity of commercial
and clinical products.
- Validation
of enzymatic, spectrophotometric, osmometry and titrimetric assays.
- Validation
of laboratory equipment and associated software including microplate
readers, spectrophotometers (UV/VIS, IR), titrators, osmometers.
- Validation
of cleanrooms, coldrooms, stability cabinets, incubators, laminar flow
hoods, water systems, compressed gas systems.
- Development
of analytical and sampling methods for cleaning validation.
- Development
of product specifications, SOP's, validation and stability protocols
and associated reports in support of QA/QC functions for compliance
to GMP and QSR regulations.
- Assist
clients for PAI inspections and in achieving ISO certification.
- Audit
contract analytical laboratories, raw material suppliers and manufacturers
to GLP and GMP Standards.
- International
experience (U.S., Europe, Asia) auditing manufacturing, analytical and
distribution facilities.
- Management
of manufacturing functions for clinical and commercial peptide production,
formulation and fill/finish at facilities in the U.S. and abroad.
CORPORATE EXPERIENCE
Validation Systems, Inc.:
Laboratory Services Manager/Validation Specialist
- Managed
all aspects of fully validated cGMP compliant analytical laboratory
providing Microbiological services to the pharmaceutical, biotechnology
and medical device industries. Responsibilities included management
of personnel, facilities, safety, purchasing, sales/marketing, billing,
document control and enforcement of GMP’s.
- Validation/qualification
projects included cleanrooms, laminar flow hoods, water systems, compressed
gas systems, laboratory equipment, cleaning of lyophilizers, pacemakers
and filling equipment.
Cytel Corporation: Supervisor,
Quality Control
- Wrote
and reviewed product specifications, SOP's, validation and stability
protocols and reports in support of QC/QA functions.
- Developed,
instituted and supervised raw materials testing program.
- Supervised
in-process, final product and stability testing.
- Contracted
and audited analytical labs and raw material suppliers.
- Trained
personnel in procedures, technical analyses and cGMP's.
- Contributed
to product control section of CMCs of INDs and development of corporate
QA/QC policy.
Invitrogen Corporation: Quality
Control Manager
- Developed
and implemented programs for:
- Quality
and stability testing and documentation of products.
- Qualification
of vital raw materials.
- Troubleshooting
out-of-specification products.
Stratagene
/ Medical Biology Institute: Research Associate
- Studied
the role of IL-6 in human arthritis and developed techniques for cloning
large oncogenes.
- Studied
IgE and its regulation in arthritis and allergic reactions.
California State University, Fullerton:
Research Assistant
- Investigated
the molecular basis for toxin production in yeast.
- Instructor
for Microbiology and Mycology laboratories.
ANALYTICAL / REAEARCH TECHNOLOGIES
- Analytical
- HPLC, TLC, TOC, Karl Fischer titration, electrophoresis, densitometry,
refractometry, melting point, osmometry, enzymatic assays.
- Molecular
Biology/Immunology - DNA library construction and screening, mapping,
sequencing, blotting, PCR, tissue culture, small animal handing, T-cell
fusion, immunoassays (ELISA, RIA, Pandex).
- Microbiology
- bacterial/fungal identification, environmental monitoring, water testing,
LAL, bioburden and sterility.
- Coordinated
and reviewed contract testing for GC, MS, IR, AA, NMR testing, amino
acid analysis and peptide sequencing.
ADDITIONAL TRAINING / PROFESSIONAL MEMBERSHIPS / ACTIVITIES
- Development
of Specifications for Biotechnology Pharmaceutical Products.
- HPLC
Validation and Compliance for the Pharmaceutical Laboratory.
- LAL
Methodologies, Testing Protocols and Regulatory Guidelines.
- Millennium
Software Training. Waters Corporation.
- Aquastar
Karl Fischer Workshop. EM Science.
- GMP/ISO9000/Total
Quality Management.
- Conducting
Effective Quality Audits.
- FDA
Workshop for Out of Specification Guidance for Laboratory Testing
- Member
of the American Society for Microbiology (ASM), Parenteral Drug Association
(PDA), American Society for Quality (ASQ) and International Society
for Pharmaceutical Engineering (ISPE).
- GMPs
for Laboratories, Northern California Partnership Among Industry &
Regulators.
- Instructor
for the Center for Continuous Education. "Adventitious Contaminants
in the Manufacture of Healthcare Products".
|
