Associate Director, Drug Product

🕒 Abril 16

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CG Oncology

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2010

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 $120.000.000 Series E em 2022-11

Biotechnology • Healthcare Insurance • Pharmaceuticals

A CG Oncology é uma empresa biofarmacêutica clínica em estágio avançado, focada no desenvolvimento e comercialização de imunoterapias oncolíticas inovadoras para pacientes com câncer de bexiga. O principal produto em investigação da empresa, o cretostimogene grenadenorepvec, visa proporcionar uma opção terapêutica que poupa a bexiga, melhorando a qualidade de vida dos pacientes acometidos. Com estudos clínicos em andamento destacando os potenciais benefícios de suas terapias, a CG Oncology busca atender as necessidades não atendidas no tratamento do câncer de bexiga.

Descrição

• 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.

🎯 Requisitos

• 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

🏖️ Benefícios

• 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