Claudia Buser
- Role
- Cmc Project Leader at Sanofi
- Location
- Framingham, MA, US
- LinkedIn followers
- 500 followers
About Claudia Buser
PhD manager and scientist with 25 years industrial experience in process development…
Experience
Cmc Project Leader
Sep 2016 — Present
Leader in CMC technical development and manufacturing across multiple modalities in oncology and rare diseases. Lead CMC teams in collaboration with Program teams and providing comprehensive CMC analysis to senior management. Responsibilities include: • Provide scientific and strategic leadership on development and manufacturing activities to support drug development programs from early stage through late-stage, PPQ, filing and approvals • Provide planning and execution of activities for clinical supplies, oversight of technology transfer and production at CMO for drug substance and drug product manufacturing and testing
Skills
- Drug Development
- Cell Culture
- Process Simulation
- Science
- Pharmaceutical Industry
- Biopharmaceuticals
- Assay Development
- 21 Cfr Part 11
- Fda
- Biotechnology
- Gmp
- Technology Transfer
- Manufacturing
- Protein Chemistry
- Validation
- Capa
- Lifesciences
- Change Control
- Antibodies
- Sop
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