1992 -1995 Principal Engineer, Sterility Assurance @
1988 -1992 Scientist Ii, Manufacturing Support @ Baxter Healthcare Corporation Diagnostics Division
1986 -1988 Associate Supervisor @
John Spoden Education
Northern Illinois University
Bachelor of Science (Biology)
1981-1985
John Spoden Skills
FDA
GMP
Regulatory Affairs
Validation
Regulatory Submissions
Pharmaceutical Industry
IND
Drug Development
Technology Transfer
Clinical Development
NDA
Aseptic Processing
Biotechnology
eCTD
Quality Assurance
Clinical Trials
Pharmaceutics
Biologics
CMC
SOP
Cross-functional Team...
Management
HPLC
CAPA
Life Sciences
Oncology
CMC Regulatory Affairs
Program Management
Regulatory Filings
Process Improvement
Generic Programming
Sterility Assurance
Lifesciences
Budgets
u.s. Food and Drug Administration Fda
Cross Functional Team Leadership
u.s. Food and Drug Administration
John Spoden Summary
John Spoden, based in Kirkland, WA, US, is currently a Vice President of Regulatory Affairs - CMC at Encoded Therapeutics, Inc.. John Spoden brings experience from previous roles at Lundbeck, Alder Biopharmaceuticals Inc. (Nasdaq: Aldr), Omeros Corporation and Dendreon. John Spoden holds a 1981 - 1985 Bachelor of Science in Biology @ Northern Illinois University. With a robust skill set that includes FDA, GMP, Regulatory Affairs, Validation, Regulatory Submissions and more. John Spoden has 3 emails and 4 mobile phone numbers on RocketReach.
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