Senior Scientist, Analytical Development

CG Oncology

11h•Remote

About The Position

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.

Requirements

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

Responsibilities

Lead development, qualification, transfer, and lifecycle management of analytical methods to support PPQ, and 2nd generation product development, and commercial readiness.
Serve as the analytical lead for CDMOs/CROs and CTLs, ensuring high-quality execution, clear expectations, timely delivery, and proactive issue resolution.
Author and contribute to analytical sections of regulatory filings (IND/BLA), ensuring data integrity, compliance, and readiness for regulatory inspections.
Drive analytical strategies for characterization, comparability, and stability, ensuring alignment with phase-appropriate and commercial requirements.
Partner across CMC, Quality, Regulatory, and Manufacturing to provide data-driven insights that enable timely, high-quality decision-making.
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.
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.
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.
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.