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Stability Scientist
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Full-time
- The Principal Scientist Stability is responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile.
- 8+ years of experience in Stability Program Management for small molecules (oral and sterile product)
- Strong understanding of stability ICH guidelines and cGMP regulation
- Very good understanding on Regulatory CMC, US/EU/ROW submission requirements for stability
- Hand on experience on handling QC Deviation OOS / OOT, authorship, interpret results
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