Senior Manager, CMC Analytical Development
Tasks
- Author reports protocols and methods
- Communicate results internally and externally
- Develop and validate analytical methods
- Manage analytical documentation
- Manage reference standard program
- Manage stability studies and trend analysis
- Oversee contract development and manufacturing organizations
- Provide analytical support for API and Drug Product development
- Support and author regulatory content
- Support quality audits
Perks/Benefits
- 401k
- Career development
- Employee stock purchase
- Health insurance
- Hybrid work
- Mental health support
- Paid time off
- Parental leave
- Pre-tax benefits
Skills/Tech-stack
Analytical method validation | Decision Making | EMA | FDA | GC | GC-MS | HPLC | ICH | KF | LC-MS | Method validation | PH meters | Problem Solving | Project Management | Regulatory guidelines | UV-Vis | UV/VIS spectroscopy | Vendor communication
Education
Roles
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