Manager, Regulatory Affairs (CMC) @ (October 2013 - May 2017)
Associate II - Specialist, Regulatory Affairs CMC @ (September 2009 - October 2013)
Validation Engineer II @ (December 2005 - October 2009)
Manufacturing Associate II @ (December 2003 - December 2005)
Danielle Turner Education
Northwestern University - Kellogg School of Management
RAPS Executive Development Program Certificate (Executive Leadership)
2025-2025
UC Santa Barbara
Bachelor of Science (B.S.) (Chemical Engineering)
1999-2003
Danielle Turner Skills
Aseptic Processing
Biologics
Biotechnology
CAPA
CMC
Change Control
Change Management
Common Technical Document (CTD)
Communication
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
Customer Service
EMA
Equipment Validation
FDA
FDA Regulatory Submisions
GMP
Global Regulatory Compliance
Global Regulatory Strategy
Leadership
Microsoft Excel
Microsoft Office
Oral Communication
Partner Relationship Management
Pharmaceutical Industry
Process Validation
Product Life Cycle
Project Management
Regulatory Affairs
Regulatory Submissions
Root Cause Analysis
Standard Operating Procedure (SOP)
Strategic Development
Strategic Planning
Strategy
Team Leadership
Teamwork
U.S. Food and Drug Administration (FDA)
Validation
Yellow Belt
cmc regulatory strategy
eCTD
Corrective And Preventive Action Capa
Cross Functional Team Leadership
U.S. Food And Drug Administration Fda
Standard Operating Procedure Sop
Corrective and Preventive Action
Standard Operating Procedure
u.s. Food and Drug Administration
Danielle Turner Summary
Danielle Turner, based in San Diego, CA, US, is currently a Senior Director, Regulatory Affairs CMC at Halozyme, Inc.. Danielle Turner brings experience from previous roles at Halozyme, Inc., Shire and Baxter International Inc.. Danielle Turner holds a 2025 - 2025 RAPS Executive Development Program Certificate in Executive Leadership @ Northwestern University - Kellogg School of Management. With a robust skill set that includes Aseptic Processing, Biologics, Biotechnology, CAPA, CMC and more. Danielle Turner has 1 emails and 2 mobile phone numbers on RocketReach.
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