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Eikon Therapeutics, a biopharmaceutical company founded on Nobel Prize-winning innovations in molecular imaging, seeks a Senior Scientist, Analytical CMC to lead analytical chemistry and manufacturing controls (CMC) strategy for drug development programs from IND-enabling studies through clinical development, registration, and commercial readiness.
In this role, you will serve as the CMC Analytical Lead for assigned drug substance and drug product programs, coordinating analytical activities, tracking deliverables, communicating risks, and supporting program milestones in collaboration with senior technical and cross-functional stakeholders. You will provide program-level leadership and oversight while maintaining hands-on analytical expertise.
Key responsibilities include:
- Leading analytical method development, troubleshooting, qualification, transfer, and validation for drug substance, intermediates, raw materials, and drug product across development phases
- Providing hands-on laboratory-facing analytical support for non-GMP sample analysis, including certificate of analysis (CoA) creation, method development, troubleshooting, and data interpretation
- Overseeing CRO/CDMO analytical activities, including review of methods, protocols, reports, deviations, investigations, and data summaries to ensure quality and scientific soundness
- Contributing to phase-appropriate analytical control strategies, including specifications, method readiness, reference standards, impurity control, stability strategy, and shelf-life planning
- Collaborating with Research, Drug Substance, Drug Product, Regulatory Affairs, Quality Assurance, Manufacturing, Supply Chain, and Clinical Operations to ensure analytical deliverables support development and regulatory filings
You bring strong technical expertise in analytical method development and validation, solid understanding of CMC, GMP, and regulatory expectations, and demonstrated ability to manage multiple priorities while translating scientific data into practical decisions. You excel at communicating complex scientific concepts to cross-functional teams and collaborating with external partners to advance analytical strategies.
