Sr. Manager, Upstream MSAT

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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.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

Non‑small Cell Lung Cancer (NSCLC)

HARMONi:
Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR‑mutated, locally advanced or metastatic non‑squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

HARMONi‑3:
Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first‑line metastatic NSCLC.

HARMONi‑7:
Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first‑line metastatic NSCLC.

HARMONi‑GI3:
Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

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 of 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…