Ina Menzl
Companion Diagnostics | Precision Medicine | Senior Level Leader | IVD Development
- Role
- Global Diagnostic Development Lead at Amgen
- Location
- Tucson, AZ, US
- LinkedIn followers
- 500 followers
About Ina Menzl
I am a senior-level leader and scientist with expertise in cancer biology and companion diagnostic (CDx) development who is enthusiastic about precision medicine. I am goal oriented and self-motivated and able to adapt to changing timelines and goals- Extensive expertise in in-vitro diagnostic (IVD) assay development and experienced in immunohistochemistry (IHC) and in-situ hybridization (ISH) on automated platforms as well as in pathology- Deep understanding of design control and experienced in regulatory submissions, pre-submissions and approvals for medical devices and including interacting with FDA/regulatory bodies- Experience in performance study applications (PSA) in the IVDR environment- Experienced in mitigating risks for CDx assay submissions- Proficient in supporting clinical site initiations for clinical trials- Expertise in developing CDx strategies in collaboration with business development- Effective in leading R&D scientists and in interacting cross-functionally.
Experience
Global Diagnostic Development Lead
Mar 2024 — Present · Tucson, AZ, US
Education
University of Hohenheim
Dipl. Biol. (equivalent to M. SC.)
University of Hohenheim
Doctor of Philosophy (PhD)
Skills
- Confocal Microscopy
- Cell Biology
- Western Blot
- Protein Chemistry
- Biochemistry
- Molecular and Cellular Biology
- Antibodies
- Western Blotting
- Molecular and Breast Pathology
- Life Sciences
- Antibody Development
- Immunohistochemistry
- Biotechnology
- Cancer Research
- Cell Culture
- Immunofluorescence
- Molecular Biology
- Cell
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