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.
Summary of Job
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.
Essential Functions:
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.
Education
BS, MS or PhD in Pharmaceutical Sciences, Engineering or related Life Sciences is required (MS/PhD preferred).
Experience
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).
Experience with starting up and operating a biopharma manufacturing facility is a plus.
Process and analytical skills
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.
Non-Technical Skills
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.
Working Conditions: Requires up to 50% domestic and international travel,
The anticipated salary for this position will be $135,000 to $160,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
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
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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