Senior Manager, Analytical Sciences at Summit Therapeutics in Princeton, NJ

Job description

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. Senior Manager, Analytical Sciences Location: Princeton, New Jersey Position Summary The Senior Manager, Analytical Sciences will provide scientific and technical leadership for analytical activities supporting biologic products from clinical development through post-approval support. This role is responsible for advancing robust analytical strategies, overseeing method development, validation, and transfer, and contributing to product characterization, comparability assessments, and regulatory submissions. The successful candidate will combine strong technical expertise with effective external partner management, sound judgment, and a flexible, hands-on approach in a dynamic development environment. Key Responsibilities Lead analytical method development, qualification, validation, and transfer activities for biologic drug substances and drug products. Design and oversee extended product characterization studies to establish a comprehensive understanding of product quality attributes. Develop analytical strategies and execute comparability assessments supporting process changes, manufacturing changes, formulation changes, technology transfers, and product lifecycle activities. Author and critically review analytical sections of regulatory submissions and responses to health authority questions. Ensure analytical programs align with relevant ICH guidelines and global regulatory expectations across preclinical, clinical, registration, and post-approval stages. Provide scientific interpretation of analytical data, identify risks, and recommend practical, phase-appropriate solutions. Manage contract laboratories, contract development and manufacturing organizations, and other external partners, including defining scope, monitoring timelines and deliverables, reviewing technical work, and resolving issues. Partner cross-functionally with Process Development, Formulation, Manufacturing, Quality, Regulatory Affairs, and other CMC functions to deliver integrated development plans. Contribute to continuous improvement