Scorpion Therapeutics
Senior Scientist, Bioanalytical Sciences
Scorpion Therapeutics, Waltham, Massachusetts, United States, 02254
Role Summary
Crescent is seeking a Senior Scientist, Bioanalysis to manage bioanalytical activities supporting preclinical and clinical programs. This individual will partner with internal teams and CROs to design, validate/transfer, and oversee bioanalytical assays (e.g., ligand-binding and LC–MS/MS), managing sample analysis, data quality control, interpretation, and reporting to generate high-quality concentration data supporting PK. Responsibilities include planning and authoring bioanalytical documents (plans, protocols, reports), ensuring data integrity and regulatory compliance (GLP/GCP), and managing the operational aspects of outsourced work (budgeting, SOWs, audits, and sample logistics). Responsibilities
Assist in the development and execution of bioanalytical (BA) strategies to meet current and future regulatory and scientific requirements. Manage the implementation of bioanalytical contracts/SOW, plans, and reports. Oversee day-to-day operations of CROs: coordination of shipments of test article, necessary reagents and samples, protocol and data review, provide technical assistance, and report review. Work with internal and external subject matter experts and other relevant disciplines to manage and resolve scientific, technical or quality issues and improve study consistency, quality, efficiency and effectiveness. Coordinate the bioanalysis activities for individual preclinical/clinical programs to ensure alignment of BA data deliverables. Contribute to regulatory documents (i.e. IND, CTA, BLA etc.), providing high-quality bioanalytical content and responses to queries. Conduct scientific audits of CROs in collaboration with the QA department. Instill and adhere to GLP and GCP regulations, relevant SOPs, protocols, policies and safety procedures. Qualifications
PhD or MS in Chemistry, Pharmaceutical Sciences, Pharmacokinetics or related discipline with a minimum of 5 years of industry or related experience. Strong understanding of bioanalytical technology and methods both for small and large molecules and peptides. Proven experience managing external CROs (SOWs, timelines, budgets, data review) with excellent organizational and project-management skills. Well-grounded in drug-development practices—data-driven decision making; contribution to protocols, bioanalytical plans/reports, and clinical study reports. Ability to work in a dynamic team-oriented environment as demonstrated by participating in and contributing to cross-functional teams. Small molecule DMPK experience is a plus. Education
PhD or MS in Chemistry, Pharmaceutical Sciences, Pharmacokinetics or related discipline with a minimum of 5 years of industry or related experience.
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Crescent is seeking a Senior Scientist, Bioanalysis to manage bioanalytical activities supporting preclinical and clinical programs. This individual will partner with internal teams and CROs to design, validate/transfer, and oversee bioanalytical assays (e.g., ligand-binding and LC–MS/MS), managing sample analysis, data quality control, interpretation, and reporting to generate high-quality concentration data supporting PK. Responsibilities include planning and authoring bioanalytical documents (plans, protocols, reports), ensuring data integrity and regulatory compliance (GLP/GCP), and managing the operational aspects of outsourced work (budgeting, SOWs, audits, and sample logistics). Responsibilities
Assist in the development and execution of bioanalytical (BA) strategies to meet current and future regulatory and scientific requirements. Manage the implementation of bioanalytical contracts/SOW, plans, and reports. Oversee day-to-day operations of CROs: coordination of shipments of test article, necessary reagents and samples, protocol and data review, provide technical assistance, and report review. Work with internal and external subject matter experts and other relevant disciplines to manage and resolve scientific, technical or quality issues and improve study consistency, quality, efficiency and effectiveness. Coordinate the bioanalysis activities for individual preclinical/clinical programs to ensure alignment of BA data deliverables. Contribute to regulatory documents (i.e. IND, CTA, BLA etc.), providing high-quality bioanalytical content and responses to queries. Conduct scientific audits of CROs in collaboration with the QA department. Instill and adhere to GLP and GCP regulations, relevant SOPs, protocols, policies and safety procedures. Qualifications
PhD or MS in Chemistry, Pharmaceutical Sciences, Pharmacokinetics or related discipline with a minimum of 5 years of industry or related experience. Strong understanding of bioanalytical technology and methods both for small and large molecules and peptides. Proven experience managing external CROs (SOWs, timelines, budgets, data review) with excellent organizational and project-management skills. Well-grounded in drug-development practices—data-driven decision making; contribution to protocols, bioanalytical plans/reports, and clinical study reports. Ability to work in a dynamic team-oriented environment as demonstrated by participating in and contributing to cross-functional teams. Small molecule DMPK experience is a plus. Education
PhD or MS in Chemistry, Pharmaceutical Sciences, Pharmacokinetics or related discipline with a minimum of 5 years of industry or related experience.
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