Principal Scientist, Analytical Development

Principal Scientist, Analytical Development

Location : Cambridge, MA (Onsite)
Science: Small Molecule Therapeutics

Job 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.