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Dennis Roberts Location
Austin, TX, US
Dennis Roberts Work
2022 -now Director, Quality Assurance Chemistry, Manufacturing and Controls. @
2021 -2023 Senior Regulatory Consultant @
2019 -2022 Sr. Project Management Consultant @
2018 -2019 CMC Consultant @
2015 -2018 Executive Director, Product Development @
2015 -2015 Consultant @
2015 -2015 Consulant @
2009 -2013 Vice President @
2006 -2009 Sr. Director and Director Quality Operations @
2005 -2006 CMC Contractor @
2001 -2005 Director Quality Control @
1992 -2001 Dir R and D @ Akorn
Dennis Roberts Education
Washington State University
B.S Chemistry (Chemistry)
1977-1982
Richland High
(Chemistry)
1975-1977
Dennis Roberts Skills
Good Manufacturing Practice (GMP)
Analytical Chemistry
Regulatory Compliance
Drug product manufacturing
GMP
Validation
FDA
Change Control
Biopharmaceuticals
Stabilty Programs
Process Validation
Quality Control Testing
Analytical method validation
Regulatory writing (CMC)
FDA inspections
Sop
CAPA
R&D
HPLC
GLP
IND
Aseptic Processing
Quality Assurance
GCP
Clinical Trials
u.s. Food and Drug Administration Fda
Operations
Product Development
Development
Regulatory Writing Cmc
Legal
Regulations
Pharmaceutical Manufacturing
Leadership
Process Improvement
u.s. Food and Drug Administration
Regulatory Writing
Dennis Roberts Summary
Dennis Roberts, based in Austin, TX, US, is currently a Director, Quality Assurance Chemistry, Manufacturing and Controls. at Ophirex, Inc.. Dennis Roberts brings experience from previous roles at DSI - DS InPharmatics, DSI - Design Space InPharmatics LLC, Xeris Pharmaceuticals, Inc. and Xeris Pharmaceuticals. Dennis Roberts holds a 1977 - 1982 B.S Chemistry in Chemistry @ Washington State University. With a robust skill set that includes Good Manufacturing Practice (GMP), Analytical Chemistry, Regulatory Compliance, Drug product manufacturing, GMP and more. Dennis Roberts has 3 emails and 2 mobile phone numbers on RocketReach.
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