Associate Director, Drug Product
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Job Description
Associate Director leading drug product development and manufacturing at CG Oncology. Ensuring robust and compliant deliverables for clinical and commercial programs.
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.
Requirements:
- 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
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
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