Sr. Manager, Upstream MSAT

About Summit

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.

Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

The Manager/Senior Manager, Upstream MSAT will lead upstream process engineering activities to support commercialization of Ivonescimab. This role focuses on upstream biologics production, providing technical oversight and troubleshooting across development and manufacturing. The position collaborates closely with CMC, quality, regulatory teams, and external CDMOs to ensure successful tech transfer, process readiness, and delivery of CMC milestones.

• Lead and support upstream process design, optimization, troubleshooting, and tech transfer for drug substance manufacturing.
• Drive process development, characterization, validation, and risk management across internal teams and external CDMOs.
• Collaborate cross-functionally with QA, RA, supply chain, and CMOs; provide clear updates to project leadership.
• Contribute to regulatory documentation and support CMC programs and sub-teams.
• Support BLA filing and related activities, including responding to RFIs, preparing for PAI, PAS submissions, annual product reviews, and other regulatory commitments.
• Resolve upstream manufacturing issues and facilitate problem-solving and contingency planning.
• Promote continuous improvement for process robustness, efficiency, and scalability.
• Oversee tech transfer and manage deviations, change controls, and risk assessments.
• Travel as needed for tech transfer, scale‑up, and external collaboration.
• Perform all other duties as assigned.

• Bachelor’s degree in Engineering, Biochemistry, Pharmaceutical Sciences, or related field; MS or PhD preferred.
• Minimum 6+ years of experience in biologics DS manufacturing with emphasis on late‑phase monoclonal antibody development.
• Proven ability to design and execute Design of Experiments (DoE) studies, including multivariate data analysis and interpretation to optimize process parameters and enable data‑driven decisions.
• Demonstrated success in process scale‑up and technology transfer from bench to pilot and commercial scale.
• Strong background in tech transfer across multiple systems, scales, and manufacturing sites.
• Hands‑on experience in scale‑down model qualification (SDMQ), process characterization (PC), validation (PV), and PPQ campaigns is strongly preferred.
• Experience in authoring regulatory submissions, including IND, IMPD, and BLA documentation, is strongly preferred.
• Familiarity with cell line development and media optimization is a plus.
• Exceptional attention to detail, organizational skills, and commitment to quality and technical excellence.
• Strong interpersonal skills; able to work independently, in cross‑functional teams, and with external partners and regulators.
• Proven ability to deliver high‑quality results under pressure and tight timelines.

The pay range for this role is $168,000 - $190,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

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