Senior Analytical Development Scientist

1 day ago


Cambridge, Massachusetts, United States Stratacuity Full time
Job Title: Principal Scientist, Analytical Development

Stratacuity is seeking a highly skilled Principal Scientist to join our team in Cambridge, MA. As a key member of our Analytical Development group, you will play a critical role in guiding pharmaceutical advancements from inception through clinical stages.

Key Responsibilities:
  • Develop and implement specialized testing methodologies for small molecule drugs using HPLC and GC.
  • Oversee impurity characterization and stability studies for drug substances and products, ensuring regulatory compliance.
  • Collaborate with internal and external partners to manage analytical testing and development activities, ensuring projects are completed on schedule.
  • Provide expertise in CMC, quality processes, and regulatory submissions, ensuring internal and external project alignment.
Requirements:
  • PhD in Analytical Chemistry with 6+ years of experience in CMC analytical development for small molecule drug substances and products.
  • 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.
About Stratacuity:

We are an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.



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