Senior Analytical Development Scientist
2 days ago
The Principal Scientist in Analytical Development at Stratacuity plays a pivotal role in guiding pharmaceutical advancements from inception through clinical stages, collaborating with internal and external partners to drive project success.
Key Responsibilities- Develop and implement specialized testing methodologies for small molecule drugs using HPLC and GC, ensuring regulatory compliance.
- Oversee impurity characterization and stability studies for drug substances and products, guaranteeing adherence to GMP/ICH guidelines.
- Manage analytical testing and development activities with external partners to maintain project timelines and deliverables.
- Collaborate on CMC, quality processes, and regulatory submissions, providing internal and external project alignment.
- PhD in Analytical Chemistry with 6+ years of experience 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.
At Stratacuity, we value ethics and build lasting relationships with exceptional biopharmaceutical talent. We take great care to protect your personal information and will not share it without your direct prior consent. As an Equal Employment Opportunity/Affirmative Action Employer, we welcome qualified applicants from diverse backgrounds and will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
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Cambridge, Massachusetts, United States Stratacuity Full timeJob OverviewThe Senior Research Scientist in Analytical Development at Stratacuity plays a pivotal role in driving pharmaceutical advancements from inception through clinical stages, collaborating with internal and external partners to ensure seamless project execution.Key ResponsibilitiesDevelop and implement specialized testing methodologies for small...
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Cambridge, Massachusetts, United States Stratacuity Full timeJob Summary:The Principal Scientist in Analytical Development at Stratacuity guides pharmaceutical advancements from inception through clinical stages and collaborates with internal and external partners.Key Responsibilities:Develop specialized testing methodologies for small molecule drugs using HPLC and GC.Oversee impurity characterization and stability...
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Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob Summary:The Principal Scientist in Analytical Development at Stratacuity guides pharmaceutical advancements from inception through clinical stages and collaborates with internal and external partners.Key Responsibilities:Develop specialized testing methodologies for small molecule drugs using HPLC and GC.Oversee impurity characterization and stability...
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