Senior Manager/Associate Director, Downstream Msat

Location: Princeton, NJ (ONSITE)

Overview of Role:

The Sr Manager/Assoc Director, MSAT, is an experienced and enthusiastic process development scientist or 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, commercial control strategy authorship, and module 3 BLA/MAA authorship experience specifically supporting biologics drug substance. The role involves working with the Summit MSAT group and other CMC, quality, and regulatory stakeholders in drug substance to provide operational, strategic, and technical oversight on predominantly 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.

Role and 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).
• Contribute significant strategic direction and authorship of regulatory documents including clinical IND/IMPD and commercial BLA/MAA
• 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).
• 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.

Educational Background:

• Degree in chemical engineering, biotechnology, pharmaceutical science, or a related field. Bachelor's degree with 12+ years of relevant experience; Master's degree with 10+ years of relevant experience; PhD with 8+ years of relevant experience.

Professional Experience:

• Demonstrated experience in process development, MSAT (Manufacturing Science and Technology), and/or manufacturing in a biological environment (preferably mAbs) is essential. IND/IMPD and BLA/MAA Module 3 authorship experience and Continuous Process Verification planning and execution is critical
• Experience with health authority inspection and information request responses highly desired
• 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
• 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

Skills and Competencies:

• Data Analytics experience including JMP and other data organization (AI-based or not) platforms a strong plus
• 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.