SIGN IN
Senior Scientist, Analytical Development jobs in United States
info-icon
This job has closed.
company-logo

CG Oncology · 1 month ago

Senior Scientist, Analytical Development

CG Oncology is focused on Attacking Bladder Cancer for a Better Tomorrow and is seeking a Senior Scientist in Analytical Development. This role is central to ensuring the quality, consistency, and regulatory readiness of therapies, leading critical analytical activities that impact product quality and regulatory success.
BiotechnologyHealthcareMedical DeviceHealth CareHealth DiagnosticsOncology

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

Qualification

Analytical Method DevelopmentAnalytical Method ValidationAnalytical Method QualificationAnalytical Method TransferAnalytical Lifecycle ManagementCDMO OversightCRO OversightCTL OversightRegulatory Filings - INDRegulatory Filings - BLAGMPAnalytical CharacterizationComparability StudiesStability StudiesRisk AssessmentAnalytical Innovation

Required

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

Benefits

HIGHLY COMPETITIVE SALARIES
ANNUAL PERFORMANCE/MERIT REVIEWS
ANNUAL PERFORMANCE BONUSES
EQUITY
SPECIAL RECOGNITION
FULLY REMOTE WORK ENVIRONMENT
REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
HOLIDAYS –In 2026 we will observe 14 holidays
RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

Company

CG Oncology

twitterlinkedincrunchbase
company-logo
CG Oncology is a clinical-stage biopharmaceutical company focused on the development of oncolytic immunotherapies to combat cancer.

Funding

Current Stage
Public Company
Total Funding
$555.57M
Key Investors
Foresite Capital,TCG CrossoverDecheng Capital,Longitude Capital,ORI CapitalKissei Pharmaceutical
2024-12-12Post Ipo Equity· $238M
2024-01-25IPO
2023-08-02Series F· $105M

Leadership Team

leader-logo
Arthur Kuan
Chairman and CEO
linkedin
leader-logo
Jim DeTore
Chief Financial Officer
linkedin
Company data provided by crunchbase