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Senior Scientist and Validation Expert
2 weeks ago
Job Description:
We are seeking a highly skilled Scientist & Validation SME, QC Chemistry (18 months maternity cover) to join our team at AGC Biologics. The successful candidate will be responsible for validating analytical methods according to ICH guidelines for PhI/II and/or PhIII, driving PhI/II and PhIII/Commercial method validation activities, reviewing release and stability analytical set-ups, supporting lab technicians, authoring SOPs, and running Lab Investigations, Deviations/CAPAs, and CR cases.
The ideal candidate should possess a strong understanding of analytical chemistry, chromatography, and regulatory requirements. Fluency in written and spoken English is essential, as English is our company language.
Key Responsibilities:
- Validating analytical methods according to ICH guidelines for PhI/II and/or PhIII.
- Driving PhI/II and PhIII/Commercial method validation activities.
- Reviewing release and stability analytical set-ups.
- Supporting lab technicians with troubleshooting experience.
- Authoring SOPs and running Lab Investigations, Deviations/CAPAs, and CR cases.
About Our Culture:
At AGC Biologics, we value knowledge, trust, quality, ingenuity, accountability, and teamwork. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
