CG Oncology · 1 month ago
Associate Director, Drug Product
United States
Full-time
Remote
Lead/Staff, Director/Executive
8+ years expCG Oncology is a biotechnology company focused on developing treatments for bladder cancer. The Associate Director, Drug Product will lead the technical and operational aspects of drug product development and manufacturing, ensuring compliance and alignment with program objectives while mentoring high-performing teams.
BiotechnologyHealthcareMedical DeviceHealth CareHealth DiagnosticsOncology
Responsibilities
Provide technical and operational leadership across all aspects of drug product development and manufacturing for small molecule and/or viral products, including formulation, fill-finish, and clinical in use studies
Contribute to regulatory strategy for late-stage and commercial programs, ensuring alignment with current guidances and global expectations
Author and review drug product sections of regulatory filings, including BLA and responses to health authority information requests
Partner closely with drug substance, analytical development, quality assurance, quality control, supply chain, and regulatory groups to ensure alignment across CMC activities
Support management of external manufacturing sites in collaboration with technical SMEs to ensure aligned decision-making and smooth execution
Provide technical guidance on post-approval changes and lifecycle management strategies
Provide leadership by aligning priorities, developing talent, and empowering teams to deliver outcomes independently
Qualification
Required
Advanced degree (PhD, MS, or BS with extensive experience) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline
8+ of relevant industry experience in drug product development and manufacturing for biologics and/or cell and gene therapy products
Deep technical knowledge of drug product process development and manufacturing, including formulation, aseptic processing, and clinical in-use studies
Strong understanding of cGMP, ICH guidelines, and late-stage/commercial regulatory expectations
Demonstrated success authoring drug product BLA sections and supporting regulatory interactions
Direct experience working with CDMOs and leading external manufacturing operations
Proven people leader who develops talent and empowers teams
Demonstrates strong cross‑functional leadership with the ability to navigate ambiguity and drive results in complex, fast‑paced environments
Excellent written and verbal communication skill
Preferred
Experience with viral formulations, in-use compatibility studies, and ex-US regulatory pathways is strongly preferred
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
CG Oncology is a clinical-stage biopharmaceutical company focused on the development of oncolytic immunotherapies to combat cancer.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$555.57MKey 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
Arthur Kuan
Chairman and CEO
Jim DeTore
Chief Financial Officer
Recent News
dhvc
2026-06-18
2026-05-26
2026-05-26
Company data provided by crunchbase