Senior Analytical Development Scientist

4 days ago


Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

Job Summary: We are seeking a highly skilled Principal Scientist in Analytical Development to guide pharmaceutical advancements from inception through clinical stages and collaborate with internal and external partners.

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.
  • Manage analytical testing and development activities with external partners to keep projects on schedule.
  • Collaborate on CMC, quality processes, and regulatory submissions, providing internal and external project alignment.

Requirements:

  • PhD in Analytical Chemistry with 6+ years 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.

About Stratacuity:

At Stratacuity, we build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. We are committed to providing a safe and inclusive work environment for all our team members.

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. We welcome applications from diverse candidates and are committed to creating an inclusive workplace.



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