Senior Manager/Associate Director, Downstream 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. 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.

Colorectal Cancer (CRC) 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.

Location: Princeton, NJ (ONSITE) Overview of Role: The Sr Manager/Assoc Director, MSAT, is an experienced and enthusiastic process development scientist or engineer who will join a dynamic late-stage clinical and commercial environment working with our lead asset, Ivonescimab. The ideal candidate will have proven technical ability, commercial control strategy authorship, and module 3 BLA/MAA authorship experience specifically supporting biologics drug substance. The role involves working with the Summit MSAT group and other CMC, quality, and regulatory stakeholders in drug substance to provide operational, strategic, and technical oversight on predominantly downstream-related activities across the organization to achieve Summit milestones.

This position will require building operational relationships with Summit CDMOs and working in close collaboration internally and externally to ensure successful CMC deliverables.

Responsibilities

: Contribute to and have accountability for all Summit Downstream CMC activities, focusing on control strategy development, process validation, continued process verification, and technical troubleshooting to support drug substance and product (as needed) Support phase-appropriate downstream process development, characterization, validation, and technology transfers to or between external CDMOs for drug substance (DS). Contribute significant strategic direction and authorship of regulatory documents including clinical IND/IMPD and commercial BLA/MAA Assess and manage process risks arising from manufacturing or process changes. Develop effective working relationships with Summit project team members and external Contract Manufacturing Organizations (CMOs).

Support MSAT team objectives while providing clear and concise updates of results and reports to the project team leaders, including the Head of CMC. Work in close partnership with process scientists engineers, QA, RA, supply chain, consultants, and cross-functionally. Support CMC sub-teams and programs.