Damon K. Hunter
Accomplished Biopharmaceutical Operations Director with more than 25 years of experience with a strong focus on Quality and Compliance.
- Role
- Associate Director, Manufacturing at Biogen
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Damon K. Hunter
Experienced Biopharmaceutical Operations Director with over 25 years of experience in the biotech/pharmaceutical industry. Throughout my career, I have honed my proficiency in Quality and Compliance, ensuring that operations are executed with the highest standards. As an operations leader, I possess outstanding leadership skills and have successfully built, trained, and mentored strong teams that consistently deliver positive results.In my previous role as Director of Manufacturing Operations at Cellectis, I led the manufacturing team responsible for clinical drug substance and drug product manufacturing of cell and gene therapy products. Prior to that, as Director of Licensed Products at Duke University School of Medicine, I oversaw GMP manufacturing and facility maintenance.With a strong background in batch processing, aseptic technique, deviations management, and sterility assurance, I am well-equipped to drive operational excellence. My experience in root cause analysis and cGMP manufacturing has allowed me to develop effective operational strategies and optimize manufacturing processes.I hold a Master of Science (M.S.) degree in Chemical Engineering from the University of Arkansas. My commitment to quality and compliance has been recognized throughout my career, making me an ideal person for an operations leadership role.
Experience
Associate Director, Manufacturing
Feb 2024 — Present · Raleigh-Durham-Chapel Hill, NC, US
Head of Small Scale and Flexible Volume Manufacturing (Upstream) organization that produces therapeutic medicines that treat neurological and rare diseases.
Education
University of Arkansas
Bachelor of Science (B.S.), Chemical Engineering
University of Arkansas
Master of Science (M.S.), Chemical Engineering
Skills
- U.s. Food and Drug Administration (Fda)
- Manufacturing
- Six Sigma
- Aseptic Processing
- Quality Assurance
- Purification
- Cell Culture
- Hplc
- 21 Cfr Part 11
- Capa
- Quality Control
- Gmp
- Trackwise
- Chromatography
- Lean Manufacturing
- Biotechnology
- U.s. Title 21 Cfr Part 11 Regulation
- Sop
- Fda
- Continuous Improvement
- Quality System
- V&V
- Process Simulation
- Standard Operating Procedure (Sop)
- Sds-Page
- Corrective and Preventive Action (Capa)
- Vaccines
- Chemical Engineering
- Lims
- Validation
- Change Control
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