Jenny Lin Gao
- Role
- Project Manager, Cmc Ra Biopharm Dev Projects at GSK
- Location
- Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Jenny Lin Gao
An established pharmaceutical CMC project leader with 10+ years of quality and regulatory…
Experience
Project Manager, Cmc Ra Biopharm Dev Projects
Jun 2023 — Present
Provide integrated regulatory strategy supporting CMC development * Deliver high quality global Regulatory CMC submissions to enable clinical investigations and marketing applications * Lead responses to questions received from Health Authorities * Support major inspections, including PAI * Manage all post-approval activities and Life-cycle variations/events * Interact with Health Authorities (FDA, EMA,etc)* Understand, review and communicate changes in regulatory…
Skills
- Circular Dichroism
- Qc
- Dsc
- X-Ray Crystallography
- Biophysical Characterization
- Tem, Xrd, Kinetic Assay
- Validation
- Biologics
- Instrumentation
- Capa
- Analytical Chemistry
- Chromatography
- Mass Spectrometry
- Nmr
- Lc-Ms
- Uv/Vis
- Characterizations
- Ftir
- Characterization
- Gmp
- Ind/Bla Filling
- Intrinsic Fluorescence
- Differential Scanning Calorimetry
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