Senior Principal Scientist - Process Chemistry

7/12/22

Cambridge, MA

1756

Our client is a well established clinical stage pharmaceutical company. They are currently seeking a Principal/Senior Principal Scientist with significant knowledge, experience in synthetic process chemistry and in-depth understanding of small molecules drug substance-related activities to join our CMC technical operations group in Cambridge, MA. The Principal/Senior Principal Scientist is recognized as a subject matter expert both within and outside the department, representing Tech-Ops in cross-functional settings at Cerevel as well as with external CMOs.

Key Responsibilities

      • Lead the design, planning, and execution of multi-step organic syntheses of small molecules as a member of cross-functional development teams
      • Lead drug substance scale-up and GLP manufacturing activities
      • Efficiently design and develop high quality chemical processes for drug substance
      • Ensure synthetic route, pharmaceutical form, and compound properties are appropriate for development and scale up
      • Proactively work to manage vendors with regard to scope, timelines, and deliverables
      • Present technical data to cross functional teams and senior management as needed
      • Lead Tech-Transfer and validation activities on multiple projects
      • Collaborate with quality investigations or events and resolve them in a timely manner

Required Qualifications

      • 8+ years of relevant work experience
      • In depth knowledge in synthetic route development and process optimization
      • Experience with technology transfer and outsourced work on process development
      • Preparation of necessary CMC documents suitable for regulatory filings as needed
      • Management of on-time API deliveries for drug safety studies, formulation development, and preclinical studies
      • Working knowledge of the appropriate analytical techniques such as HPLC, LCMS, NMR etc.
      • Experience in API manufacturing associated with small molecules in different phases of clinical development
      • Knowledge of regulatory guidance with authoring experience
      • May require up to 10% travel

Desired Qualifications

      • Desire to work in a fast-paced, dynamic environment
      • A high degree of autonomy
      • Strong problem solving and trouble shooting skills

Education

      • Ph.D. (or equivalent degree) in relevant discipline 8+ years industry experience
      • BS and 15+ years
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