API Analytics Early and/or Late Phase Project Lead (Secondment 6-12 Months)
USA - CT - Groton, United States
USD 106K-176K (estimate) Senior-level Full Time
Tasks
- Apply phase appropriate analytical strategies
- Author analytical sections of regulatory documentation
- Deliver regulatory ready analytical documentation
- Develop analytical strategy and control strategy
- Lead analytical discussions with increasing independence
- Lead analytical workstreams in project teams
- Manage risk based decisions
- Partner with process chemistry quality regulatory supply stakeholders
- Resolve technical issues and support decision making
- Support specification setting and justification using risk based approaches
- Track and communicate risks timelines deliverables
Perks/Benefits
Skills/Tech-stack
Analytical Chemistry | Chromatographic Software | Chromatography | Computational modeling | Data Visualization | Dissolution | Electronic Notebooks | GMP | Gas Chromatography | Infrared spectroscopy | LIMS | Liquid Chromatography | Magnetic Resonance | Mass Spectrometry | Modeling software | NMR | Nuclear Magnetic Resonance | Particle Size | Particle-size analysis | Raman spectroscopy | SFC | Spectroscopy | Veeva
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