Dennis Roberts Email & Phone Number
Director, Quality Assurance Chemistry, Manufacturing and Controls. @ Ophirex, Inc.
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Dennis Roberts Location
- Austin, TX, US
Dennis Roberts Work
- Director, Quality Assurance Chemistry, Manufacturing and Controls. @ (October 2022 - Present)
- Senior Regulatory Consultant @ (May 2021 - February 2023)
- Sr. Project Management Consultant @ (August 2019 - May 2022)
- CMC Consultant @ (July 2018 - August 2019)
- Executive Director, Product Development @ (July 2015 - June 2018)
- Consultant @ (January 2015 - January 2015)
- Consulant @ (January 2015 - January 2015)
- Vice President @ (November 2009 - March 2013)
- Sr. Director and Director Quality Operations @ (June 2006 - November 2009)
- CMC Contractor @ (June 2005 - June 2006)
- Director Quality Control @ (July 2001 - June 2005)
- Dir R and D @ Akorn (April 1992 - June 2001)
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
- Aseptic Processing
- Clinical Trials
- Drug product manufacturing
- GCP
- IND
- Quality Assurance
- U.S. Food and Drug Administration (FDA)
- 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 and Xeris Pharmaceuticals, Inc.. 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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