Lead Analytical Scientist, Pharmaceutical Development

6 days ago


Cambridge, Massachusetts, United States Stratacuity Full time
Job Overview

The Senior Research Scientist in Analytical Development at Stratacuity plays a pivotal role in driving pharmaceutical advancements from inception through clinical stages, collaborating with internal and external partners to ensure seamless project execution.

Key Responsibilities
  • Develop and implement specialized testing methodologies for small molecule drugs using HPLC and GC, ensuring accuracy and precision.
  • Oversee impurity characterization and stability studies for drug substances and products, guaranteeing regulatory compliance and adherence to industry standards.
  • Manage analytical testing and development activities with external partners, ensuring timely project delivery and effective communication.
  • Collaborate with cross-functional teams to develop and implement CMC, quality processes, and regulatory submissions, fostering internal and external project alignment.
Requirements
  • PhD in Analytical Chemistry with 6+ years of experience in CMC analytical development for small molecule Drug Substance and Drug Product.
  • Expertise in method development for small-molecule drugs, with broad analytical expertise including HPLC, GC, MS, and NMR techniques.
  • Knowledgeable in GMP/ ICH guidelines and adept at managing stability studies.
  • Skilled in guiding CDMOs, drafting regulatory documents, and leading cross-functional project teams.


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