AS&T (Analytical Science & Technology) Manager
On-site · Shanghai, Shanghai, China
Job Summary
Oversee Analytical Product Stewards and ensure strong analytical support across product lifecycle activities. Lead and implement global AS&T requirements/programs in the assigned ESO QA Network and act as project lead in cross functional ESO AS&T project teams. Manage analytical method transfers (AMTs) within ESO; support external supplier selection/qualification and analytical trouble shooting; assist regulatory submissions from an analytical perspective; contribute to stability programs at CMOs, interpret stability data for product shelf-life, and provide scientifically sound conclusions. Support QA activities including investigations (e.g., OOS), CAPA implementation, and the maintenance of the AS&T Quality System; collaborate with QAM and QMS to ensure state-of-the-art testing, monographs, and inspections readiness. Role requires advanced degree, 8+ years in pharma analytics/QA, expertise in analytical techniques, cGMP/ICH knowledge, and strong English communication.
Required Qualifications
- Advanced university degree (Master’s or equivalent) in Natural Sciences (Chemistry, Pharmacy, Biotechnology, Biology)
- Minimum of 8 years’ experience within the pharmaceutical industry in quality control or analytical development that includes method development, method validation, stability testing, method transfers
- Expertise in different analytical techniques required
- Thorough knowledge of cGMP requirements, ICH guidelines, major pharmacopeial requirements, regulatory requirements
- Excellent communication in English and advanced negotiation skills
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