Senior Scientist, Analytical Development

About CG Oncology, Inc.

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

About the role

At CG Oncology, this role is central to ensuring the quality, consistency, and regulatory readiness of our therapies as we advance toward BLA and commercialization. The Senior Scientist, Analytical Development will lead critical analytical activities that directly impact product quality, regulatory success, and ultimately patient outcomes. This is a high-visibility role that partners across Technical Operations, Quality, and Regulatory while working closely with external CDMOs to deliver analytical excellence in a fast-paced, pre-commercial environment.

Location: Remote

Essential Functions

• Analytical Method Development, Readiness and validation
• • Lead development, qualification, transfer, and lifecycle management of analytical methods to support PPQ, and 2nd generation product development, and commercial readiness.
• External Partner Execution & Oversight
• • Serve as the analytical lead for CDMOs/CROs and CTLs, ensuring high-quality execution, clear expectations, timely delivery, and proactive issue resolution.
• Regulatory & Inspection Readiness
• • Author and contribute to analytical sections of regulatory filings (IND/BLA), ensuring data integrity, compliance, and readiness for regulatory inspections.
• Analytical Strategy & Lifecycle Management
• • Drive analytical strategies for characterization, comparability, and stability, ensuring alignment with phase-appropriate and commercial requirements.
• Cross-Functional Collaboration & Decision Support
• • Partner across CMC, Quality, Regulatory, and Manufacturing to provide data-driven insights that enable timely, high-quality decision-making.
• Risk Assessment & Issue Escalation
• • Proactively identify analytical risks related to method performance, timelines, or partner execution.
  • Drive risk mitigation strategies, escalate critical issues appropriately, and ensure resolution plans are clearly defined and executed.
• Analytical Innovation & Continuous Improvement
• • Identify opportunities to enhance analytical methods, workflows, and technologies to improve efficiency, robustness, and scalability.
  • Drive continuous improvement initiatives that support long-term product and platform evolution.
• Knowledge Management & Technical Leadership
• • Serve as a subject matter expert in analytical development, providing guidance, mentoring, and knowledge sharing across teams. Ensure critical analytical knowledge is captured, organized, and leveraged to strengthen organizational capability.
• Program Execution & Timeline Accountability
• • Own analytical deliverables across development programs, ensuring alignment with program timelines and milestones. Track progress, manage competing priorities, and communicate status, risks, and trade-offs to stakeholders

Qualifications

• PhD in relevant field with 3+ years experience OR MS (6+ years) OR BS (8+ years).
• Experience in biotech/pharma analytical development, CDMO oversight, and GMP

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s)