Manager, Manufacturing Support

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, Manufacturing Support will play a critical role in providing tactical direction and leadership for drug substance (DS) manufacturing at the new Kyowa Kirin North America monoclonal antibody (mAb) drug substance manufacturing facility in Sanford, NC. The manager will be responsible for solution & buffer manufacturing, weigh and dispense operations and material management. In addition they will backup manufacturing managers during batch operations.

During the startup phase of the facility the Manager will provide leadership for our operational readiness program. They will work with all functional groups and our Tech Transfer Team to drive the program. They will provide project management leadership, develop plans, timelines, codependency’s, procedures, and implement curricula and learning plans. They will also be heavily involved with facility startup activities including digital systems, equipment and process validations as well as DS tech transfer activities.

As a people leader, you will embody compassionate, people-centric leadership to guide and support our team. You will collaborate closely with others, fostering a collaborative, inclusive, and supportive environment while driving team development. Your work will reflect the organization’s values and integrity in all your actions. Utilizing situational leadership and emotional intelligence, you will align diverse viewpoints, manage stakeholders, and make empathetic decisions to address individual and team needs effectively.

You will also be results-oriented, ensuring that your team not only adapts to challenges but also delivers measurable outcomes that align with business objectives. Additionally, you will help teams navigate through change and uncertainty with resilience and clarity, enabling them to adapt to fast-evolving, rapidly scaling environments and meet new challenges in the biotech industry with a patient-focused mindset.

This position will report directly to the Director, Manufacturing in Sanford, NC.

• 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 and its management via Standard Work.
• Team management:
  Hiring, training, and develop a team of operators and other individual contributors.
• KPI’s and Communication:
  Deliver on KPI’s and communicate KPIs and batch status at Tier meetings. Escalate issues that cannot be resolved within the process centric team.
• Troubleshooting and
  
  Collaboration:
  
  Use the Continuous Improvement loop to identify related issues. Work with Process Engineers, MS&T, Maintenance and QA in the process centric team to resolve these issues. Utilize Kaizen events to improve operational efficiency.
• Materials Management:
  Oversee the planning, procurement, storage, and distribution of materials to ensure production needs are met cost‑effectively and efficiently. This includes preparation of buffers and solutions to meet demand.
• Equipment maintenance and management:
  Understand and be able to implement Lean Manufacturing principles such as TPM to maintain process equipment in a compliant manner.
• Technical leadership:
  Be the subject matter expert on the manufacturing process providing technical knowledge, oversight and leadership for the manufacture of mAb DS.
• Documentation:
  Author and review SOP’s and Work Instructions to facilitate DS manufacturing.
• Safety and Compliance:
  Ensures all processes are performed in accordance with Safety and…