Senior MSAT Engineer; Upstream

Position: Senior MSAT Engineer (Upstream)

Summary of Job

The Senior MSAT Engineer will provide technical leadership for the technical transfer, manufacturing, and testing of clinical and commercial drug substances at Kyowa Kirin’s new mAb drug substance manufacturing facility in Sanford, NC. The role requires a deep understanding of monoclonal antibody manufacturing processes and bioanalytical assays to ensure monitoring, troubleshooting, and continuous improvement of the facility.

In this position, the engineer will facilitate the transfer of clinical and commercial drug substance manufacturing from other Kyowa Kirin sites or CMOs. By collaborating with internal and external teams, the engineer will drive the development of robust manufacturing processes, ensuring seamless technology transfers and operational readiness.

This is an individual‑contributor role that emphasizes collaborative, inclusive, and resilient work in a fast‑paced environment that places patients at the center of all efforts.

Essential Functions

• Technical Leadership

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Provide technical knowledge, project management, and leadership for the commercialization of mAb drug substances.

• Process Management

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Lead the transfer of drug substance processes to and from the manufacturing facility and optimize processes for efficiency and quality.

• Troubleshooting

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Conduct investigations and troubleshoot process deviations, trends, or issues, including designing and performing small‑scale experiments to support technology transfer or investigations.

• Design of Experiments (DoE):

Plan, conduct, and analyze DoE using statistical tools to drive process optimization and problem solving.

• Change Control

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Create and implement corrective actions utilizing the site’s change control process.

• Collaboration and Alignment

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Collaborate with Global R&D, CMC, CDMOs, Process Engineering, Manufacturing, QA, and QC to ensure effective process transfer and maintenance.

• Documentation

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Author and review technical reports, process transfer summaries, batch records, and other documents.

• Trending/Reporting

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Maintain process databases, monitor batch‑to‑batch consistency, and support preparation of Continued Process Verification and Annual Product Reviews.

• Compliance

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Ensure all changes and methods are documented and compliant with cGMP requirements, collaborating with QA on change actions.

• Reporting and Presentations

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Develop project status reports, lead investigations, and facilitate alignment in group settings.

Education

• BS, MS, or PhD in Pharmaceutical Sciences, Engineering, or related Life Sciences (MS/PhD preferred).

Experience

• Experience with MSAT, Process development, Process engineering, or Tech transfer preferred.
• Minimum 5 years of purification experience in the biotech industry.
• Industry experience in mAb upstream/cell culture and harvest process preferred.
• Direct experience in technical transfer (process scale‑up and site‑to‑site transfer) in the biotech industry.
• Experience with deviation, investigation, RCA, CAPA, and continuous process monitoring.
• Demonstrated project management skills.
• Excellent analytical and communication abilities.
• Good understanding of Good Manufacturing Practices and applicable regulations (e.g., ICH).
• Experience with startup and operation of a biopharma manufacturing facility is a plus.

Process and Analytical Skills

• Expertise in bench‑scale mAb upstream operations and use of bioanalytical instruments.
• Proficiency in statistical analysis and DoE to optimize process parameters.
• Advanced competency in MS Office Suite for data management and reporting.

Non-Technical Skills

Results‑oriented, able to navigate ambiguity, set clear outcomes, track progress, and follow through commitments. Manages tasks efficiently, adapts to change with clarity, and fosters inclusive collaboration. Communicates with care, actively listens, and considers diverse perspectives to foster productive interactions. Embraces continuous learning, maintains a growth mindset, and promotes a healthy work‑life balance.

Work Conditions

100% on‑site; no hybrid or remote work. Requires up to 50% domestic and international travel.

Salary

The anticipated salary for this position will $135,000 to $155,000

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Actual salary may vary based on…