Senior MSAT Engineer

Kyowa Kirin•Sanford, NJ

16h•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 supports upstream and downstream manufacturing operations and cell-based assays, and facilitates transfers of Phase II, Phase III, and early commercial processes from other Kyowa Kirin sites or contract manufacturing organizations. As an individual contributor, the engineer works with internal and external partners to develop robust processes and ensure efficient, compliant technology transfers and operational readiness. The position leads commercialization and process-transfer activities, optimizes processes, troubleshoots investigations and deviations, and uses laboratory experiments and Design of Experiments (DoE) to support process improvement and problem-solving. It also contributes to change control, technical documentation, process monitoring, continued process verification, and annual product reviews, ensuring work complies with current Good Manufacturing Practice (cGMP) requirements. The role is initially based at a construction site and ultimately at a biotechnology manufacturing facility in Sanford, NC. It is 100% on-site, with up to 20% domestic travel and limited international travel.

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 (CAPA).
Demonstrated project management skills.
Excellent analytical and communication abilities.
Good understanding of Good Manufacturing Practices and applicable regulations and guidelines, including ICH.
Ability to operate bench-scale laboratory equipment for monoclonal antibody processes.
Proficiency in Microsoft Office Suite, statistical analysis, and Design of Experiments (DoE).
Strong organizational skills, attention to detail, and work ethic.
Ability to work effectively across functions and in a global environment, communicate thoughtfully, adapt to change, and deliver measurable results.

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, insight, project management, and leadership for commercialization of mAb drug substances.
Lead transfers of drug substance processes to and from the manufacturing facility.
Evaluate and optimize processes to improve efficiency and quality.
Lead investigations and troubleshoot process deviations, trends, and issues.
Design and perform small-scale laboratory experiments and studies supporting technology transfers and investigations.
Plan, conduct, and analyze experiments using appropriate statistical tools to support 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 compliance with cGMP requirements.
Write change controls, perform impact assessments, and work with Quality Assurance and Manufacturing to establish and execute change action plans.
Design, develop, and execute project-status and data reporting.
Lead investigation discussions and facilitate alignment in individual and group settings.

Benefits

401(k) with company match.
Annual bonus program (sales bonus for sales positions).
Generous paid time off and holiday schedule, including summer and winter shutdowns.
Sick days.
Volunteer days.
Medical, dental, prescription drug, and vision healthcare benefits.
HSA and FSA programs.
Well-being and work-life programs.
Life and disability insurance.
Concierge services.
Long-term incentive program, subject to job level and performance.
Pet insurance.
Tuition assistance.
Employee referral awards.