Brian Dillion
President, Phylax Pharma Consultants
- Role
- Senior Associate at Jeff Yuen & Associates, Inc
- Location
- Wilmington, NC, US
- LinkedIn followers
- 500 followers
About Brian Dillion
Experienced Vice President of Quality / Regulatory / Compliance and transformational leader with a demonstrated history working in the pharmaceutical CMC industry. Skilled in the oversight of Quality and Regulatory Compliance in support of sterile product manufacturing, solid oral dosage manufacturing, API manufacturing,managing DEA and controlled substance compliance, QC laboratory operations, and Regulatory Affairs. Experienced in successfully managing budgets in aggressive private equity environments. Directly involved in the successful management of over 35 regulatory inspections, including FDA, MHRA, EMA, Health Canada, and many more.
Experience
Senior Associate
Jan 2024 — Present
Education
University of North Carolina Wilmington
MBA
2003 — 2006
Roanoke College
Chemistry
1982 — 1984
Hampden-Sydney College
Chemistry
1981 — 1982
Carson-Newman University
BS, Chemistry
1984 — 1986
Skills
- Change Control
- Gxp
- Quality Auditing
- Aseptic Processing
- Chemistry
- Pharmaceutics
- Drug Discovery
- Clinical Trials
- Lc-Ms
- Dissolution
- CRO
- Trackwise
- Drug Development
- Gcp
- Biopharmaceuticals
- Regulatory Requirements
- Ind
- Glp
- 21 Cfr Part 11
- Validation
- Formulation
- Contract Manufacturing
- Uv/Vis Spectroscopy
- Chromatography
- Quality Assurance
- Analytical Chemistry
- Computer System Validation
- Uv/Vis
- Cleaning Validation
- Quality System
- V&V
- Gas Chromatography
- Regulatory Submissions
- Clinical Development
- Pharmacovigilance
- Regulatory Affairs
- Gmp
- Standard Operating Procedure (Sop)
- Drug Delivery
- Sop Development
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