Analytical Development - Manager / Sr. Manager
Tasks
- Apply ICH FDA EMA guidelines
- Author CMC regulatory content
- Author development protocols and reports
- Communicate analytical results
- Conduct stability trend analysis
- Develop and approve specifications
- Develop validate analytical methods
- Manage GMP stability studies
- Manage analytical documentation in QMS
- Manage analytical quality control activities
- Manage reference standard program
- Oversee CDMO analytical development
- Perform CMC analytical regulatory submissions
- Support API and drug product process development
- Support quality audits
- Verify compendial methods
Perks/Benefits
- 401k match
- Comprehensive paid medical leave
- Comprehensive paid parental leave
- Employee stock purchase program
- Employer paid medical/dental/vision
- FSA
- Flexible paid time off
- HSA employer contributions
- Hybrid work model
- Mental health support
- Subsidized lunch
- Subsidized parking
Skills/Tech-stack
Analytical Method Development | CDMO management | CMC Regulatory | EMA | FDA | GC | GCMS | GMP | HPLC | ICH | IMPD | IND | KF | LCMS | Management System | Method Development | Method validation | Method verification | PH measurement | QC testing | Quality Management System | Quality management | Reference standards | Regulatory Submissions | Specification Development | Stability Studies | USP dissolution | UVVis spectroscopy | Vendor management
Education
N/A
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