Senior Manager, Upstream MSAT

Responsibilities

• Provide technical leadership for upstream process characterization, validation, and commercial manufacturing support
• Lead technology transfer activities across internal teams and CDMOs, including scale-up and PPQ execution
• Support clinical and commercial manufacturing alignment with development timelines and supply plans
• Manage process risks, deviation investigations, root cause analysis, CAPA, and change control
• Author and review regulatory submissions including IND/IMPD/BLA/MAA Module 3 sections
• Oversee PPQ execution and ensure GMP compliance and inspection readiness
• Drive continuous improvement initiatives to enhance process robustness and scalability
• Travel as needed to support manufacturing and CDMO oversight

Requirements

• Degree in chemical engineering, biotechnology, pharmaceutical science, or a related field
• Experience with CHO mammalian cell culture processes (seed train, bioreactors, media strategies)
• Direct experience in process scale-up and technology transfer across manufacturing sites
• Experience performing facility fit assessments and evaluating process equipment
• Proficiency in data analysis and statistical tools such as JMP or DOE
• Strong project management and communication skills

Preferred Qualifications

• Experience with large-scale (>10 kL) stainless steel bioreactors and centrifugation transfer
• Experience in late-stage process development, characterization, and validation
• Experience authoring IND/IMPD and BLA/MAA Module 3 content or CPV

About the Company

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs through clinical studies in the field of oncology.