Manager, Solutions Prep

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.

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 in Drug Substance manufacturing operations, with primary responsibility for Solutions/Buffer Preparation and the ability to effectively partner with and support Upstream Manufacturing operations when needed. The individual will also provide operational support for Upstream Manufacturing activities and possess sufficient upstream process knowledge to effectively collaborate with and support Upstream Manufacturing operations 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.

• 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 a working knowledge of upstream manufacturing processes, including cell culture, bioreactor operations, harvest activities, and process monitoring, sufficient to effectively support cross‑functional manufacturing activities.
• Operational Support: Support operational decision‑making and manufacturing execution for Upstream Manufacturing activities when required, including providing leadership support and cross‑functional coverage as needed.
• 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…