Description

You will lead late-stage development and launch activities for monoclonal antibodies, partnering with CDMOs to ensure robust drug substance production. This role involves applying QbD frameworks, supporting tech transfer and PPQ, and collaborating across the integrated TechOps team to deliver high-quality therapies.

Requirements

• PhD in biology, chemistry, biochemistry, or chemical engineering with 7+ years biologics development experience
• Late-phase development and commercialization experience with monoclonal antibodies
• Tech transfer to CDMOs and scale-up/validation/PPQ support including person-in-plant
• Process and economic modeling of DS manufacturing processes
• Excellent cross-functional collaboration and communication skills

Responsibilities

• Develop product understanding and control strategies using QbD and risk assessment
• Support clinical and commercial GMP DS manufacture including tech transfer and campaign analysis
• Author technical reports, batch records, and provide technical oversight to CDMO partners
• Lead investigations and resolve deviations; analyze data to optimize process performance
• Develop process characterization and PPQ strategies; support regulatory submissions and inspections