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.

Overview of Role: We are seeking a highly experienced and strategic Senior Principal Engineer/Associate Director of MSAT - Drug Product to join the CMC team and be a key contributor to ongoing process development, technology transfer, process validation, BLA/MAA/IND/IMPD authoring and readiness, and agency interaction activities, in preparation for commercialization and incremental clinical/commercial batch production of our main asset. This role will focus on leading DP Tech transfer(s), authoring technical reports and on providing content to the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met. The ideal candidate will bring significant experience in biologics manufacturing, sterile drug product operations, and regulatory expectations.

Responsibilities

: Provide technical expertise for phase-appropriate drug product process development, characterization, validation, and technology transfer for sterile drug product (DP). Assess and manage process risks arising from manufacturing or process changes. Serve as a primary or supporting technical interface with external CDMOs and internal manufacturing teams.

Lead or significantly contribute to implementation of process, product, and site changes across the product lifecycle. Support and guide execution of clinical and commercial batch manufacturing activities to meet development and supply timelines. Assist in the authorship, data verification, update, and/or review of regulatory filings.

Provide technical feedback during regulatory agency inquiries.

Requirements

through person in plant. Collaborate closely with Regulatory, Quality, Supply Chain, and other CMC functions to ensure integrated planning and execution. Ensure GMP compliance across all assigned activities.

Support audits, inspections, and continuous improvement initiatives.

Senior Principal Engineer/Associate Director, Drug Product MSAT