Our client is seeking a Sr. Scientist – CMC Chemist & Regulatory (Seattle or fully remote)!
Our client is one of pharmaceutical leaders in neurological therapeutics, with a concentration in restoring neuronal health for patients with Alzheimer’s and Parkinson’s. They are creating innovative small molecule treatments that target specific areas needing repairs. Gain experience in process chemistry/scale up, regulatory writing and client facing work in manufacturing.
- Work with CMC team to evaluate and improve synthetic process development of compounds
- Evaluate feasibility issues, install process design optimizations, and resolve production issues
- Work in client facing capacity in manufacturing
- Coordinate with QA to implement stage appropriate analytical methods and protocols
- Participate in managing supply chain and logistics in support of clinical studies
- Maintain in-depth of CMO’s systems, capabilities, capacities, requirements, and business practices
- Monitor site performance and work to improve the CMO’s performance in-line
- BS degree with 8+ years’ experience or MS with 6+ years’ related experience or PhD with 5+ years related experience
- Minimum of 5 years industrial experience in biopharmaceutical industry
- Knowledge of cGMP’s for pharma manufacturing
- Knowledge of quality systems, investigations, corrective actions, and change management
- Familiarity with Medicinal Chemistry principles and implementation