Senior MSAT Engineer (Downstream)

Kyowa Kirin North America•Sanford, NC

22h•$135,000 - $160,000•Onsite

About The Position

The Senior MSAT 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 and bioanalytical 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 a critical role in facilitating the transfer of clinical and 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 MSAT 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 center of your efforts.

Requirements

BS, MS or PhD in Pharmaceutical Sciences, Engineering or related Life Sciences is required (MS/PhD preferred).
Experience with MSAT, Process development, Process engineering, Tech transfer preferred.
Minimum 7+ years (BS), 5+ years (MS), or 3+ years (PhD) of industry experience in mAb downstream/purification process.
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 regulations).
Expertise in bench-scale mAb downstream operations and the use of bioanalytical instruments.
Proficient in statistical analysis and DoE to optimize process parameters.
Advanced competency in MS Office Suite for data management and reporting.
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently.
Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.
Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.
Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness.
Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset.
Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.
Contribute positively by recognizing achievements and encouraging a healthy work-life balance.
Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.
Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.
Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC.
Work is 100% on-site. This is not a hybrid or remote role.

Nice To Haves

Experience with starting up and operating a biopharma manufacturing facility is a plus.

Responsibilities

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 optimize 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 lab to support technology transfer or investigations.
Design of Experiments (DoE): Plan, conduct, and analyze DoE using appropriate statistical tools to drive process optimization 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 manufacturing batch records and provide technical inputs.
Trending/Reporting: Maintain process databases and monitor batch-to batch consistency of operations. Support preparation of Continued Process Verification and Annual Product Reviews
Compliance: Ensuring 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 establishment and execution of change action plan.
Reporting and Presentations: Design, develop, and execute relevant project status and data reporting, lead discussions regarding investigations, and facilitate alignment in individual and group settings.

Benefits

401K with company matching
Discretionary Profit Sharing
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
HSA & FSA Programs
Well-Being and Work/Life Programs
Long-Term Incentive Program (subject to job level and performance)
Life & Disability Insurance
Concierge Service
Pet Insurance
Tuition Assistance
Employee Referral Awards