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Senior/Executive Director, Upstream Process Development

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ArriVent is looking for a highly motivated, entrepreneurial individual to lead upstream process development from pre-clinical to MAA, and post approval life cycle management. In this role, you will be responsible for managing cell line development, process development, tech transfer, scale-up, clinical and commercial drug substance manufacturing at CDMOs. Lead CMC teams.

Key Responsibilities

• Serve as the subject matter expert for cell line development, clone selection, upstream process development, optimization, transfer and scale up, characterization and validation.
• Work with partners and CDMOs to develop and optimize cell culture, fermentation and harvest processes with a focus on scalability, robustness, and efficiency for clinical and commercial use.
• Oversee clinical and commercial manufacturing. Review development plan/reports, tech transfer documents and batch records. Provide support, including PIP as needed.
• Lead preparation and review of CMC sections related to cell line and upstream development in INDs, IMPDs, MAAs, BLAs, and other regulatory submissions. Respond to agency questions.
• Lead CMC teams. Responsible for overall CMC development strategy, timeline and budget.
• Work closely with cross-functional teams including Development, Quality, Regulatory, and external partners and CDMOs to drive successful outcomes.

Desired Skills and Experience

• Demonstrated scientific expertise in cell line, cell culture optimization, media formulation, and large-scale bioreactor systems.
• Extensive experience in developing cell culture processes for biologics, supporting both clinical and commercial manufacturing. Experience with late-stage characterization, risk assessment, control strategy, process validation required.
• Success in authorizing regulatory submissions and responding to agency questions is key.
• Experience in leading CMC teams required. Strong knowledge of CMC, quality, compliance, and regulatory aspects of biologic product development and lifecycle management.
• Experience in managing people desired.
• Self-directed individual with a no-job-too big or too small attitude.
• Excellent verbal and written communication skills. Strong leadership skills. Excels at making good decisions and priority setting.

Education Requirement

• PhD in Biochemistry, Biochemical Engineering, Biotechnology or related field with 10+ years of biotechnology experience.

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