Director, MSAT-Drug Product 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. Overview of Role: We are seeking a highly experienced and strategic Director of MSAT - Drug Product to join the CMC team and lead ongoing process development, technology transfer, process validation, BLA/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 a small DP team, DP Tech transfer(s) and on co-authoring the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met. The ideal candidate will bring deep expertise in biologics manufacturing, sterile drug product operations, and regulatory expectations. This role will also contribute strategically and technically to future lifecycle considerations, e.g. productivity improvements, scale-up / scale-out decisions etc. Role and Responsibilities: Lead process development/characterization, tech transfer and process validation for sterile drug product, including oversight of external CDMOs and internal teams. Partner with the broader CMC team to implement process, product, and site changes Support, with the team, successful execution of clinical and commercial batch manufacturing in alignment with the development and supply timelines. Be accountable, with the team, to successfully deliver CMC chapters to regulatory documents Actively support dialogue/interaction with regulatory agencies Support PLI/PAI preparation and delivery Responsible for all stages of Process Validation, including CPV (Continuous Process Verification), in accordance with governing quality system requirements. Prioritize post-approval opportunities and develop business cases for further investment/development Foster effective communication and collaboration with internal and external stakeholders, including other CMC functions, Regulatory Affairs, Quality Assurance, and CRO’s/CDMO’s Collaboratively work across the broader CMC, regulatory and quality departments to delive