2011 -2014 Director of Regulatory Affairs and Quality Assurance @
2011 -2011 Sr. Manager, Regulatory Affairs @
2009 -2011 Head of Clinical Immunology @
2008 -2011 Sr. Manager of Regulatory Affairs @
2002 -2008 Manager of Quality Assurance and Regulatory Affairs @ Iomai
2001 -2002 Sr. Scientist @ DynPort Vaccine Company LLC, A CSC Company
2000 -2001 Manager, Molecular Biology @ ATCC
1994 -1998 R and D Specialist @
Bo Andersen Education
Danmarks Tekniske Universitet
PhD (Molecular Biology)
1983-1991
Bo Andersen Skills
Validation
FDA
Immunology
Molecular Biology
Biotechnology
Quality Assurance
R&d
Clinical Development
Clinical Trials
Vaccines
Customer Service
Regulatory Affairs
Lifesciences
GLP
Management
Process Improvement
Biopharmaceuticals
Science
Sop
Writing
Statisticians
Consulting
Market
Corrective Actions
Overseeing
Versed
Phase Ii
Clinical Research
Work Orders
Hansen
Oversight
Investigative Research
Influenza
Statistical Analysis Plans
SEP IRA
Pontiac
Danish
Sequencing
Batch Processing
Treatment
Legionella
Regulatory Compliance
Microbiology
Replication
Acid
CMC
Data Transformation
PC
Assurance
Integration
Plates
Impd
Stone
Gene Expression
Norway
Water Systems
Chr
Publications
Scientific Background
Early Stage
Workflow
Laboratory Technicians
Drug Product
Qualification
GMP
Guidance
Antibodies
Clinical Protocols
System
Cell
PCR
English
Denmark
Hygiene
Reports
Flat Patterning
Strategy
Disinfection
Testing
ACAD
Regulatory Submissions
CTD
Transcriptional Regulation
Rt Pcr
Protein Expression
Product Development
Cloning
Quality Control
Research
System Monitoring
Investigation
Environmental Monitoring
Analysis
Pro*c
Process Simulation
Mechanisms
Hospitals
Laboratory
Sterilization
Site Directed Mutagenesis
R
Cp
Accreditation
C
Selecting
Immunogenicity
Emergent
FIX Protocol
Food Industry
Chemical Engineering
Scandinavian
Data Analysis
Assay Development
Home
Phase 2
Detail
DNA
Vietnam
Cell Culture
European Union
Active
Scientific
Safety
Characterization
Blind
Operations
Author
Regulatory Requirements
Clinical Data
Flyer
Indicators
Project Planning
Pages
Microinjection
Bar
Biochemistry
Ssi
CTA
Responsibility
Usa
Regulations
Executive Management
ELISA
Vectors
Serology
Heat
Data Management
Expression
SCI Clearance
Guidelines
Diagnostics
Raw Materials
Validating
Dairy
Concerts
Business Objects
Coli
Proposal Writing
Manufacturing
Stability
Biologics
Serum
Training Needs Analysis
Sewage
Controlling
Supply Chain
Biologists
White Papers
Databases
Bo Andersen Summary
Bo Andersen, based in Gaithersburg, MD, US, is currently a Director, Regulatory Affairs CMC at AstraZeneca. Bo Andersen brings experience from previous roles at MedImmune, Vaxin Inc., Emergent BioSolutions and Intercell USA. Bo Andersen holds a 1983 - 1991 PhD in Molecular Biology @ Danmarks Tekniske Universitet. With a robust skill set that includes Validation, FDA, Immunology, Molecular Biology, Biotechnology and more. Bo Andersen has 2 emails and 3 mobile phone numbers on RocketReach.
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