Roy Alston
Sr. Director, Regulatory CMC, Aerogen Pharma
- Role
- Sr Director, Regulatory Cmc at Aerogen Pharma
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Roy Alston
Highly-motivated employee with over 16+ years industrial experience in parenteral drug product development and product development quality• Successfully supported product development, marketing approval and launch of multiple products in multiple sclerosis and biosimilars• Experienced in leading and participating in positive, productive teams within matrix and cross-functional environments, as well as with external partners• Excellent communication and project management skills
Experience
Sr Director, Regulatory Cmc
Sep 2025 — Present · Morrisville, NC, US
Education
Texas A&M University
Doctor of Philosophy (Ph.D.), Biochemistry
1999 — 2003
University of Arkansas
Bachelor of Science in Education, Secondary Education and Teaching
1982 — 1986
Texas A&M University
Master's degree, Biochemistry
1996 — 1999
Skills
- Biotechnology
- Protein Purification
- Protein Chemistry
- Monoclonal Antibodies
- Purification
- Elisa
- Cell Culture
- Formulation
- Technology Transfer
- Hplc
- Gmp
- Life Sciences
- Pharmaceutical Industry
- Biopharmaceuticals
- Quality Assurance
- Deviations
- Change Control
- Stability Studies
- Process Validation
- Internal Investigations
- Capa
- Change Management
- Expiry Assignment
- Material Review Board
- Private Pilot
- Drug Product
- Device Integration and Formulation Development
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