Kate Lew
Process development with a regulatory background. Problem solver. Process maker. Program leader.
- Role
- Site Operations Director at Sanofi
- Location
- Bend, OR, US
- LinkedIn followers
- 500 followers
About Kate Lew
Former process development engineer with an extensive regulatory background. Currently developing person in plant model and risk management for large molecule external manufacturing. Previously, I was the CMC lead on an innovative project to increase automation in regulatory submissions through use of structured content and GenAI. I have also worked as an RA CMC lead on a Stelara biosimilar and have led various teams in successful marketing applications, clinical trial applications, post-approval submissions, health authority requests, and health authority interactions (Kanjinti, Mvasi, Amjevita, and Enbrel). I consistently demonstrated strong and calm leadership of filing and tech transfer teams.I also have a strong background in process development - from product characterization to tech transfers to commercial support. I became the department lead in assessing visual inspection capabilities and training. In tech transfer, I served as the lead for the sending site and worked cross-functionally for a successful transfer and approval. For the past 10 years I have worked remotely, proving myself as a self-leader with excellent time management skills.Areas of experience: regulatory file authoring (MA, IND, CTA, post-approval supplements and variations, JNDA), health authority interactions (information requests, agency meetings), project management, process and product characterization, technology transfer (lyophilized and liquid products), and commercial support with internal and contract sites
Experience
Site Operations Director
Feb 2025 — Present
Education
UCLA
MS, Biomedical Engineering
2004 — 2006
UC Santa Barbara
Materials Science and Engineering
2003 — 2004
University of California, Berkeley
BS, Chemical Engineering and Materials Science
1998 — 2003
Skills
- Biotechnology
- 21 Cfr Part 11
- Technology Transfer
- Gmp
- Aseptic Processing
- Validation
- Capa
- Biopharmaceuticals
- Protein Chemistry
- Fda
- V&V
- Change Control
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