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Scientist- CMC Chemistry & Regulatory

WA

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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. 

Specific Responsibilities:

  • 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

 

Qualifications:

  • 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