Azadeh Timnak
Sr. Manager, Regulatory Affairs, CMC
- Role
- Sr Manager, Regulatory Affairs, Cmc at Vertex Pharmaceuticals
- Location
- Danville, CA, US
- LinkedIn followers
- 500 followers
About Azadeh Timnak
Regulatory CMC professional with broad accumulated knowledge and expertise in the biopharmeceutical industry and academia in cell and gene therapy.Extensive research and education background in bioengineering and biology including professional experience in QC analytical development in pediatric orphan disease.Expert in CMC documentation management (Sharepoint, Veeva Vault, and Title 21).Consistent in delivery of high quality regulatory CMC submissions including initial IND/ IMPD, BLA, agency responses, post- approval, ROW while meeting aggressive timelines.
Experience
Sr Manager, Regulatory Affairs, Cmc
Apr 2024 — Present
Education
Temple University
Doctor of Philosophy (PhD), Bioengineering
2013 — 2017
Shiraz University
Bachelor of Science, Materials Science and Engineering
2003 — 2007
Amirkabir University of Technology - Tehran Polytechnic
Master of Science, Biomedical Engineering- Biomaterials
2007 — 2010
Skills
- Tissue Culture
- Lyophilization
- Flow Cytometry
- Real-Time Polymerase Chain Reaction (Qpcr)
- Science
- Alamarblue
- Nanotechnology
- Cryosectioning
- Autoclave
- Multi-Color Flow Cytometry
- Biopolymers
- Life Sciences
- Powder X-Ray Diffraction
- Confocal Microscopy
- Electrospinning
- Bioengineering
- Mechanical Testing
- Cell Culture
- Cell Biology
- Picrosirius Red Staining
- Afm
- Mtt
- Western Blotting
- Research
- Reverse Transcription Polymerase Chain Reaction (Rt-Pcr)
- Biomedical Engineering
- Microsoft Powerpoint
- Biomaterials
- Scanning Electron Microscopy
- Optical Microscopy
- Tissue Engineering
- Immunocytochemistry
- Start-Up Ventures
- Microscopy
- Microsoft Word
- Minitab
- Microsoft Outlook
- Intellectual Property
- In Vivo
- Grant Writing
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