Principal Scientist, Analytical Development

Company: Apex Systems
Location: Cambridge
Posted on: November 8, 2024

Job Description:

Principal Scientist, Analytical DevelopmentLocation: Cambridge, MA (Onsite)Science: Small Molecule TherapeuticsJob Overview: The Principal Scientist in Analytical Development guides pharmaceutical advancements from inception through clinical stages and collaborates with internal and external partners.Primary Job Responsibilities:

• Develop 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.Primary Job 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.
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Keywords: Apex Systems, Newton , Principal Scientist, Analytical Development, Other , Cambridge, Massachusetts