Associate Director, Drug Product

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CG Oncology

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11 - 50 Mitarbeiter

Gegründet 2010

🧬 Biotechnologie

⚕️ Krankenversicherung

💊 Pharmazie

💰 €120.000.000 Series E im 2022-11

Biotechnology • Healthcare Insurance • Pharmaceuticals

CG Oncology ist ein biopharmazeutisches Unternehmen im Spätstadium der klinischen Entwicklung, das sich auf die Entwicklung und Kommerzialisierung innovativer onkolytischer Immuntherapien für Patienten mit Blasenkrebs konzentriert. Das Hauptprodukt des Unternehmens, Cretostimogene Grenadenorepvec, zielt darauf ab, eine blasenerhaltende therapeutische Option bereitzustellen, um die Lebensqualität der betroffenen Patienten zu verbessern. Durch laufende klinische Studien, die die potenziellen Vorteile ihrer Therapien hervorheben, bemüht sich CG Oncology, den ungedeckten Bedarf in der Blasenkrebsbehandlung anzugehen.

Beschreibung

• 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.

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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