Manager, Solutions Prep

About the role

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary of Job The Manager, Solutions Prep will play a critical role in providing tactical direction and leadership for Drug Substance (DS) manufacturing at Kyowa Kirin North America's new monoclonal antibody (mAb) manufacturing facility in Sanford, North Carolina. This role will lead manufacturing operations responsible for executing the production plan, driving operational excellence, communicating across functions, and resolving manufacturing issues through effective escalation and collaboration. During the startup phase, the Manager, Solutions Prep will provide leadership for operational readiness activities, partnering closely with cross-functional teams and the Tech Transfer organization to develop project plans, timelines, procedures, training programs, and readiness strategies. The role will also support facility startup activities, including equipment qualification, process validation, digital systems implementation, and drug substance technology transfer. This position requires strong technical expertise across Drug Substance manufacturing operations, including Solutions/Buffer Preparation and Upstream Manufacturing. The individual will be expected to provide operational support and coverage for Upstream Manufacturing activities and must possess sufficient upstream process knowledge to effectively support the Upstream Process Manager when needed. The successful candidate will leverage strong technical leadership, collaboration, and problem-solving skills to support manufacturing operations, drive continuous improvement initiatives, and ensure operational readiness and execution in a fast-paced biopharmaceutical manufacturing environment. Essential Functions Technical Skills, Knowledge, and Experience Program Management: Provide project and program management expertise during the initial design and construction phase of the project. Process Management: Have a thorough understanding of manufacturing operations and their management through Standard Work. Drug Substance Manufacturing Leadership: Provide technical leadership and operational support across multiple Drug Substance manufacturing functions, including Solutions/Buffer Preparation and Upstream Manufacturing. Upstream Manufacturing Expertise: Maintain strong working knowledge of upstream manufacturing processes, including cell culture, seed train expansion, bioreactor operations, harvest activities, and process monitoring. Operational Support: Support operational decision-making and manufacturing execution for Upstream Manufacturing activities when required, including providing coverage for the Upstream Process Manager. Cross-Functional Collaboration: Partner with Upstream Manufacturing, MS&T, Engineering, Maintenance, and Quality teams to ensure seamless manufacturing operations across Drug Substance functions. KPIs and Communication : Deliver on KPIs and communicate KPI and batch status at Tier meetings. Escalate issues that cannot be resolved. Troubleshooting and Collaboration : Use the Continuous Improvement loop to identify related issues. Work with Process Engineers, MS&T, Maintenance, and QA to resolve these issues. Utilize Kaizen events to improve operational efficiency. Equipment Maintenance and Management : Understand and implement Lean Manufacturing principles to maintain process equipment in a compliant manner. Technical Leadership : Serve as the subject matter expert on the manufacturing process, providing technical knowledge, oversight, and leadership for the manufacture of mAb Drug Substance (DS). Documentation : Author and review SOPs and Work Instructions to facilitate DS manufacturing. Safety and Compliance : Ensure all processes are performed in accordance with Safety and Compliance policies, current Good Manufacturing Practices (cGMP), and Data Integrity principles (ALCOA+), as well as all other applicable regulatory requirements. Ensure the facility is inspection-ready every day through Gemba walks, 5S practices, and Standard Work. Leadership & Collaboration Results-Oriented : Set clear priorities and drive execution against key operational objectives. Align resources effectively, remove obstacles, and maintain focus on delivering high-quality results within established timelines. Technical Leadership : Provide technical guidance and manufacturing expertise across Drug Substance operations, including Solutions/

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