Apex Systems
Principal Scientist, Analytical Development
Apex Systems, Cambridge, Massachusetts, us, 02140
Principal Scientist, Analytical Development
Location : 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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Location : 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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