Expertise in CMC Manufacturing & Strategy in mammalian and microbial systems. Experienced in the production of biopharmaceutical products including Cell Therapies, mAbs, AAV & Lentivirus, therapeutic proteins and vaccines. Expertise in technology transfer, process scale-up, characterisation and validation (PPQ) as well as PAI readiness.
Skills:
- Process development, manufacturing operations & CMC strategy.
- Has established R&D activities & infrastructure in a manufacturing facility.
- Manufacturing improvements at multiple manufacturing scales.
- Technical experience for 3 commercial products & clinical programs.
- Expertise in managing and working with global CDMOs.
- Involved in regulatory filings for originator biologics & biosimilars.
Development of small scale scalable bioreactor systems for mammalian cell culture.
- Involved in international tech transfers and scale-ups .
- Process Improvements/Optimization and process robustness.
Expertise in QbD and Six Sigma Master Black belt.
