Sr Manager, MSAT, DSP

Summit Therapeutics Sub•Princeton, NJ

8d•$155,000 - $180,000

About The Position

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. Summits 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. Summits team is inspired to touch and help change lives through Summits 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 Chinas 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: The Manager/Senior Manager, Downstream MSAT, is an experienced and enthusiastic process 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 in overall downstream production of biologics. The role involves working with the Summit MSAT group and other CMC, quality, and regulatory stakeholders in drug substance to provide operational and technical oversight on all 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.

Requirements

Degree in chemical engineering, biotechnology, pharmaceutical science, or a related field. Bachelors degree with 8+ years of relevant experience; Masters degree with 6+ years of relevant experience; PhD with 3+ years of relevant experience.
Demonstrated experience in process development, MSAT (Manufacturing Science and Technology), and/or manufacturing in a biological environment (preferably mAbs) is essential.
Proven technical knowledge in various systems (e.g. Unicorn, Delta V, etc)) and demonstrated proficiency in all downstream-related operations, including but not limited to Affinity (Protein A), Ion Exchange, Mixed-Mode, and Hydrophobic Interaction Chromatography, Virus Filtration, and Ultrafiltration / Diafiltration
Proven track record with process scale-up and technology transfer, moving from bench scale to pilot and production plant
Strong communication, management, and interpersonal skills to effectively influence across the organization and with CDMOs/CMOs.
Excellent attention to detail and organizational skills, with a focus on quality and technical excellence.
Good information management and data organization skills
Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
A track record of working under pressure and delivering high-quality results to tight deadlines.

Nice To Haves

IND/IMPD and BLA/MAA Module 3 authorship experience and Continuous Process Verification planning and execution highly preferred
Experience with technology transfer across different systems, scales, and sites is highly valued
Experience in late-stage process development, characterization and validation is highly valued
Data Analytics experience including JMP and other data organization (AI-based or not) platforms a strong plus

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). 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).
Assist in the authorship, update, and/or review of regulatory filings.
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. Facilitate problem-solving, contingency planning, and decision-making.
Provide technical support to manufacturing operations, addressing and resolving any issues that arise during downstream processing.
Drive continuous improvement to enhance process robustness, efficiency, and scalability.
Oversee tech transfer activities to ensure a seamless transition from development to manufacturing.
Manage process deviation investigations and change controls.
Travel as needed to support technology transfer, process scale-up, and collaboration with external partners.
Perform all other duties as assigned.