Manager / Sr Manager Scientist CMC analytical development
Thermo Fisher Scientific · Remote
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Role summary
Thermo Fisher Scientific seeks a Manager/Senior Manager Scientist for CMC analytical development to support therapeutic antibody manufacturing and lifecycle management. The role involves regulatory compliance, quality control oversight, analytical method management, and cross-functional collaboration with internal and external manufacturing partners.
What they're looking for
- Master's degree in chemistry, pharmaceutical sciences, bio-engineering, or related discipline
- Strong expertise in biological drug substance and product manufacturing, analytical methods, process validation
- Thorough knowledge of GMP regulations, ICH guidelines, and statistical methods
- Fluent English communication, written and spoken
- Project management skills with ability to manage multiple stakeholders and complex timelines
- Experience with quality control data management and analytical method lifecycle
- Ability to work independently and operate in dynamic biotech environments
What you'll be doing
- Oversee execution of commercial supply plans for outsourced QC testing and manage external certificates of analysis
- Lead follow-up on change controls, deviations, and out-of-specification investigations with external vendors and CMO partners
- Maintain product quality data repositories including control charts and analytical critical quality attribute trending
- Manage reference standard and critical reagent inventory levels, stability programs, and retest dating
- Review and contribute to CMC regulatory submissions and technical discussions supporting global product development
Privacy & handoff
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