Scientist

• Lead assay lifecycle activities for cell-based immunoassays, including design, execution, optimization, qualification, implementation, troubleshooting, documentation, and transfer readiness for preclinical and clinical samples
• Develop and apply cellular immunology methods, including intracellular cytokine staining, ELISpot/FluoroSpot, cytokine profiling, and related functional assays to characterize immune responses
• Support flow cytometry instrument readiness through calibrations, routine maintenance, troubleshooting, and coordination with vendors or operations teams for service and repair
• Author and review SOPs, test methods, qualification documents, technical reports, and scientific presentations
• Communicate assay strategy, data interpretation, technical risks, limitations, and recommendations to internal stakeholders, cross-functional teams, and external scientific audiences
• Apply laboratory experimentation, data analytics, automation, robotic liquid handling, and risk-based troubleshooting to improve assay performance, workflow efficiency, data quality, and bioanalytical capability
• Serve as an internal subject matter expert by providing scientific rationale, technical guidance, training, and mentoring to colleagues, junior scientists, and contractors
• Work effectively in a regulated GxP environment while maintaining complete documentation, supporting data integrity, and ensuring assay activities follow SOPs, test methods, and regulatory expectations

Senior Scientist, Pharmacokinetics

• Lead COA study projects from end to end and ensure development and establishment of fitness-for-purpose COAs, including PROs, ClinROs, PerfOs, and ObsROs
• Manage COA research projects and engage with external third parties to ensure timely project execution with quality and compliance
• Support development of disease-state and product-specific COA strategies with functional and cross-functional teams
• Execute COA strategies with functional and cross-functional teams
• Support integration of COA into early clinical development plans
• Draft regulatory documents under direction of the lead COA scientist
• Design and execute research to inform COA strategy development
• Develop and execute qualitative and psychometric analysis strategies
• Support clinical trial development, including protocols, statistical analysis plans, study reports, briefing books, and related documents
• Identify evidence gaps needed to support fit-for-purpose use of COAs
• Design and execute research to develop or modify COA instruments
• Consult on COA regulatory strategy
• Develop publications for peer-reviewed journals and scientific meetings
• Package scientific materials for patients and caregivers for dissemination and disclosure
• Partner with project management teams to deliver planned work
• Communicate project status transparently to team members
• Ensure appropriate measures and metrics are in place
• Monitor the external environment and define future needs and priorities

Scientist jobs in Pennsylvania

Senior Scientist, Pharmacokinetics

Senior COA Scientist