MSAT Engineer III

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 MS&T Engineer will play a critical role in providing technical leadership for the technical transfer, manufacturing and testing of clinical and commercial drug substances. The position requires a deep understanding of monoclonal Antibody (mAb) manufacturing processes (Upstream and Downstream) and cell‑based assays to ensure monitoring, troubleshooting and continuous improvement at the new Kyowa Kirin North America mAb drug substance manufacturing facility in Sanford, NC.

This role plays role in facilitating the transfer of Phase II, III, and early commercial drug substance manufacturing from other Kyowa Kirin sites or CMOs. Collaborating with internal and external teams, this role will drive the development of robust manufacturing processes and ensure seamless technology transfers. With deep expertise in mAb drug substance manufacturing and analytical methods, the Senior MS&T Engineer will lead transfer efforts for both new and existing products, ensuring efficiency, compliance, and operational readiness.

As an individual contributor, you will take a compassionate and people‑focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs.

You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast‑paced environment while keeping the needs of patients at the centre of your efforts.

This position will report to Senior Manager of MSAT.

• Technical leadership:
  Provide technical knowledge and insight, project management and leadership for the commercialization of mAb drug substances.
• Process management:
  Lead the transfer of drug substance processes to and from the manufacturing facility. Evaluate and optimise processes to improve efficiency and quality.
• Troubleshooting:
  Lead investigations and perform troubleshooting following process deviations, trends or issues. This includes designing and performing small‑scale experiments/studies in the lab to support technology transfer or investigations.
• Design of Experiments (DoE):
  Plan, conduct, and analyse DoE using appropriate statistical tools to drive process optimisation and problem‑solving.
• Change Control:
  Create and implement corrective actions utilizing the site’s change control process.
• Collaboration and Alignment:
  Collaborate and align with Global R&D and CMC, CDMOs, Process Engineering, Manufacturing, QA, QC to ensure processes are transferred and maintained effectively.
• Documentation:
  Author and review technical reports, process transfer summaries and other documents. Review upstream and downstream manufacturing batch records and provide technical input to MFG technical document writing specialists.
• Trending/Reporting:
  Maintain process databases and monitor batch‑to‑batch consistency of operations. Support preparation of Continued Process Verification and Annual Product Reviews.
• Compliance:
  Ensure that changes to processes and methods are documented and carried out in compliance with cGMP requirements. Write change controls, perform impact assessment and collaborate with QA and manufacturing on the…