Manager, Downstream MSAT

Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:

• HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).
• HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Overview of Role: The Manager, Downstream MSAT, is an enthusiastic process engineer who will work within a vibrant development environment as we approach the commercialization of our lead asset, Ivonescimab. The ideal candidate will have proven technical ability in the downstream production of biologics. The role involves working with the Summit MSAT group and other CMC, quality, and regulatory stakeholders in drug substance and product development to provide operational and technical oversight on all downstream-related activities across the organization and support the supply of required material/information 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.

Role and Responsibilities:

• Contribute to and have accountability for all Summit CMC activities, focusing on the design of new or improved downstream processes and technical troubleshooting to support drug substance (DS) and product (DP) development, control strategies, specifications, etc.
• Support phase-appropriate downstream process development, characterization, validation, and technology transfers to or between external CDMOs for drug substance (DS).
• Assist in planning and execution of downstream activities.
• 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 generation, 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.
• Perform risk assessments to identify and mitigate potential issues in downstream processes.
• Manage process deviation investigations and change controls.
• Travel as needed to support technology transfer, process scale-up, and collaboration with external partners.
• All other duties as assigned.

Experience, Education and Specialized Knowledge and Skills:

• Degree in chemical engineering, biotechnology, pharmaceutical science, or a related field.
• Bachelor’s degree in chemical engineering, biotechnology, pharmaceutical science, or a related field with 8+ years of relevant experience; Master’s degree in chemical engineering, biotechnology, pharmaceutical science, or a related field with 6+ years of relevant experience; PhD in chemical engineering, biotechnology, pharmaceutical science, or a related field with 5+ years of relevant experience.
• Demonstrated experience in process development, MSAT (Manufacturing Science and Technology), and/or manufacturing in a biological environment (preferably mAbs).
• Proven technical knowledge in various systems (e.g. Deta V, Unicorn) and demonstrated proficiency in all downstream-related (development and scale-up) operations, including but not limited to Protein A and Ion-Exchange Chromatography, Virus Filtration, UF/ DF.
• Proven track record with process scale-up and technology transfer, moving from bench scale to pilot and production plant.
• 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.
• Experience in IND and BLA, validation planning, and execution is highly valued.
• Experience in commercial lifecycle management (commercial process optimizations, comparability, control charting and process capability).
• 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.