Kelly Zinn
CAR-T & Viral Vector Product Quality Leader | Cell & Gene Therapy Expert | Commercial Strategy | CMC, Quality & Regulatory
- Role
- Director - Product Quality at Cargo Therapeutics
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Kelly Zinn
I\'m passionate about advancing cell and gene therapy through robust quality strategies that balance innovation with compliance. My scientific background (PhD in Molecular Biology) combined with industry experience enables me to bridge technical complexities with practical CMC quality solutions. In my spare time I ski and mountain bike.#CellTherapy #GeneTherapy #CART #ViralVectors #ProductQuality #QualityAssurance #QualityControl #AnalyticalDevelopment #QualityOperations #CMC #Commercialization #Regulatory #BLA #IND #FDA #Biopharmaceuticals #Biotechnology #CellAndGeneTherapy #AdvancedTherapies
Experience
Director - Product Quality
Apr 2024 — Present
Led quality strategy resulting in successful CAR-T IND approval - Established comprehensive JoS, specifications, and stability strategy for both CAR-T and viral vector products- Provided technical quality oversight for method qualification, method validation, process characterization, comparability assessments, tech transfer activities, and BLA and commercial readiness
Education
University of Minnesota-Twin Cities
Ph.D.
University of Minnesota-Twin Cities
B.A.
Skills
- Biochemistry
- Pcr
- Genetics
- Biotechnology
- Bioinformatics
- Molecular Biology
- Scientific Writing
- Statistics
- Dna
- Qpcr
- Confocal Microscopy
- Molecular Cloning
- Genomics
- Microscopy
- Public Speaking
- Leadership
- Project Management
- Procurement
- Supply Chain
- Aerospace
- Manufacturing
- Logistics
- Change Management
- R&D
- Lean Manufacturing
- Six Sigma
- Mrp
- Process Improvement
- Project Planning
- Materials Management
- Pro Engineer
- Product Development
- Strategic Planning
- Continuous Improvement
- Standard Work
- Materials
- Strategic Sourcing
- Global Sourcing
- Systems Engineering
- Ms Project
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