Senior Manager, Downstream MSAT

Responsibilities

• Contribute to and have accountability for all Summit Downstream CMC activities, focusing on control strategy development, process validation, and technical troubleshooting
• Support phase-appropriate downstream process development, characterization, validation, and technology transfers to external CDMOs
• Assess and manage process risks arising from manufacturing or process changes
• Develop effective working relationships with Summit project team members and external CMOs
• Assist in the authorship, update, and review of regulatory filings
• Provide technical support to manufacturing operations and resolve downstream processing issues
• Drive continuous improvement to enhance process robustness, efficiency, and scalability
• Oversee tech transfer activities to ensure seamless transition from development to manufacturing
• Manage process deviation investigations and change controls

Requirements

• Degree in chemical engineering, biotechnology, pharmaceutical science, or a related field
• Bachelor’s degree with 8+ years of relevant experience, Master’s with 6+ years, or PhD with 3+ years
• Demonstrated experience in process development, MSAT, and/or manufacturing in a biological environment (preferably mAbs)
• Technical knowledge in systems such as Unicorn or Delta V
• Proficiency in downstream operations including Protein A, Ion Exchange, Mixed-Mode, HIC, Virus Filtration, and UF/DF
• Proven track record with process scale-up and technology transfer from bench to production

Preferred Qualifications

• IND/IMPD and BLA/MAA Module 3 authorship experience
• Continuous Process Verification planning and execution experience
• Experience with technology transfer across different systems, scales, and sites
• Experience in late-stage process development, characterization, and validation
• Data analytics experience including JMP

About the Company

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