Senior MSAT Engineer

Kyowa Kirin North America•Sanford, NC

18h•$135,000 - $155,000•Onsite

About The Position

The Senior MSAT Engineer provides technical leadership for technology transfer, manufacturing, and testing of clinical and commercial monoclonal antibody (mAb) drug substances at Kyowa Kirin North America’s mAb drug substance manufacturing facility in Sanford, North Carolina. The role requires knowledge of upstream and downstream mAb manufacturing processes and cell-based assays to support process monitoring, troubleshooting, and continuous improvement. The position facilitates the transfer of Phase II, Phase III, and early commercial drug substance manufacturing from other Kyowa Kirin sites and contract manufacturing organizations. Working with internal and external teams, the engineer leads transfer efforts for new and existing products and supports development of robust processes, operational readiness, efficiency, and compliance. This is an individual-contributor role that calls for accountable, adaptable, patient-focused collaboration in a fast-paced environment. The role includes process optimization, investigations, small-scale laboratory studies, design and analysis of experiments, change control, technical documentation, process trending, and reporting. It works closely with Global R&D and CMC, CDMOs, Process Engineering, Manufacturing, Quality Assurance, and Quality Control to ensure processes are transferred and maintained in compliance with cGMP requirements.

Requirements

Bachelor’s or master’s degree in Pharmaceutical Sciences, Engineering, or a related life sciences field.
At least five years of purification experience in the biotechnology industry.
Experience with deviations, investigations, root cause analysis, and corrective and preventive actions.
Demonstrated project management skills.
Excellent analytical and communication abilities.
Good understanding of Good Manufacturing Practices and applicable regulations and guidelines, including ICH.
Skill operating bench-scale laboratory equipment for monoclonal antibody processes.
Proficiency in Microsoft Office Suite, statistical analysis, and Design of Experiments.
Strong organizational skills, attention to detail, and work ethic.
Ability to navigate ambiguity, set clear outcomes, track progress, follow through on commitments, and deliver measurable results.
Ability to manage tasks responsively, accountably, and efficiently.
Adaptability and ability to guide teams through evolving challenges.
Cultural sensitivity and ability to build alignment in a global environment.
Ability to listen actively, consider others’ perspectives, and manage relationships thoughtfully.
Commitment to continuous learning, knowledge sharing, and personal growth.
Ability to promote inclusive collaboration and respect diverse perspectives.
Ability to collaborate with respect, integrity, and humility and prioritize collective success.
Resourcefulness and initiative in challenging the status quo, driving innovation, and developing creative solutions.
Ability to work across functions and deliver cohesive, integrated solutions.

Nice To Haves

Master’s degree.
Experience in Manufacturing Science and Technology (MS&T), Process Engineering, or technology transfer.
Experience starting up and operating a biopharmaceutical manufacturing facility.

Responsibilities

Provide technical knowledge, project management, and leadership for commercialization of mAb drug substances.
Lead transfer of drug substance processes to and from the manufacturing facility; evaluate and optimize processes for efficiency and quality.
Lead investigations and troubleshoot process deviations, trends, and issues.
Design and conduct small-scale laboratory experiments and studies to support technology transfers and investigations.
Plan, conduct, and analyze Design of Experiments using appropriate statistical tools for process optimization and problem-solving.
Create and implement corrective actions through the site’s change control process.
Collaborate with Global R&D and CMC, CDMOs, Process Engineering, Manufacturing, Quality Assurance, and Quality Control to transfer and maintain processes effectively.
Author and review technical reports, process transfer summaries, and other documents.
Review upstream and downstream manufacturing batch records and provide technical input to Manufacturing technical documentation specialists.
Maintain process databases and monitor batch-to-batch consistency of operations.
Support preparation of Continued Process Verification and Annual Product Reviews.
Ensure process and method changes are documented and implemented in accordance with cGMP requirements.
Write change controls, perform impact assessments, and collaborate with Quality Assurance and Manufacturing on change action plans.
Design, develop, and execute project-status and data reporting.
Lead investigation discussions and facilitate alignment in individual and group settings.
Travel up to 20% domestically and make limited international trips.