Search the 22 jobs at Kyowa Kirin

The Sr. Manager, Quality Control will design and execute the operational readiness of Quality Control laboratories at a new manufacturing facility. Responsibilities include ensuring compliance with GxP standards, leading method development and validation, managing QC procedures, and overseeing staff training and performance.

The Senior Manager of FP&A will lead financial planning and analysis for the Central Nervous System, Immunology, and Public Affairs functions, collaborating with Department Heads and cross-functional teams. Responsibilities include budget management, forecasting, financial reporting, and providing analytical support to ensure financial goals are met.

The Manager, Manufacturing will oversee drug substance manufacturing operations, leading a team through the startup of a new facility. Responsibilities include strategic guidance, project management, team development, and ensuring compliance with operational standards. The role focuses on fostering collaboration and driving outcomes while supporting continuous improvement initiatives.

The Sr. Research Associate will lead and conduct in vivo pharmacologic studies related to cell and gene therapy, contribute to regulatory development, prepare various documentation, and implement measures to resolve team issues.

The Commercial Operations Excellence Manager will identify and enhance process improvements across non-sales commercial activities. Responsibilities include managing the annual brand and financial planning cycle, developing business planning strategies, improving workflows, overseeing marketing operations logistics, and ensuring compliance with regulatory guidelines.

The Sr. IT Specialist will provide technical support across the organization, troubleshoot hardware and software issues, resolve network problems, and support SMEs and System Administrators. Responsibilities include expertise in ServiceNow, application of ITIL processes, managing technical issues, system administration, ensuring security best practices, and maintaining technical documentation.

The Senior Specialist in Quality Assurance will lead activities related to the Quality Assurance organization in a new monoclonal antibody drug substance manufacturing facility. Responsibilities include ensuring compliance with GxP standards, establishing quality procedures, coordinating site activities, mentoring QA employees, and overseeing validation and qualification processes.

The Senior Research Scientist in Cell and Gene Therapy will lead pharmacologic evaluations, conduct in vivo studies, manage project timelines, and oversee team training. The role also involves preparing regulatory documentation and managing project budgets while contributing to research strategies in cell and gene therapy.

The Research Scientist will develop and optimize processes for Kyowa Kirin's cell therapy programs, analyzing data and collaborating with teams to ensure integration with manufacturing. Key responsibilities include process design, compliance with regulatory standards, and technology transfer support, while conducting experiments and maintaining documentation.

The Senior Automation Engineer will design, commission, and operate automated manufacturing systems. Responsibilities include overseeing system design and implementation, managing supplier relationships, troubleshooting networks and configurations, preparing documentation, and supporting audits while collaborating with various teams to ensure operational readiness.

The Automation Engineer III designs, commissions, and operates automated systems within the manufacturing facility, ensuring compliance with processes and documentation. They are responsible for troubleshooting, maintaining systems accountability, collaborating on new product evaluations, and supporting audits. The role emphasizes a compassionate approach and adaptability within a dynamic biotech environment.

The Senior Process Engineer will design, commission, and operate the KKNA Manufacturing Facility, focusing on Tech Transfer, Process Definition, Troubleshooting, and Process Optimization. Responsibilities include documentation creation, maintenance oversight, and collaboration with various teams to enhance manufacturing processes in the biotech industry.

The Senior Process Engineer will design, commission, and operate the KKNA Manufacturing Facility, including supporting Tech Transfer and Process Optimization. The role involves collaboration with diverse teams, technical support for manufacturing systems, and management of engineering changes, while ensuring compliance with GMP standards.

The Senior Manager, Biostatistician oversees statistical activities for clinical studies, develops protocols, statistical analysis plans, and collaborates with vendors and internal teams to ensure quality and compliance in statistical reporting and analysis.

The Director, OCX Brand will lead the brand Omnichannel/Customer Experience strategy, define brand Omnichannel/digital tactics, manage relationship with digital design partner, and ensure brand financial goals are met. Responsibilities also include budget management, mentorship for the OCX Brand, and introducing new channel solutions.

The Senior Manager of Statistical Programming and Data Operations is responsible for vendor oversight, ensuring quality TLFs, and managing CDISC datasets for regulatory submissions. This role involves collaboration with internal staff and statistical programming vendors, overseeing statistical deliverables, and preparing CDISC data submission packages. The manager also conducts programming quality control and supports process improvements.

The Senior Manager, Corporate Communications, Social Media will lead Kyowa Kirin's presence on social media by managing current channels, developing content strategies, and collaborating with internal experts. They will analyze performance, create compelling content, and ensure compliance with company policies.

The Project Engineer I will assist in the design, construction, and start-up of a new manufacturing facility, working closely with site leadership to manage projects and ensure they meet safety and operational standards. This role involves coordinating project activities, participating in the facility's development phases, and collaborating with various teams to drive project success.

The Global Lead of HR Systems and Data is responsible for defining, implementing, and managing global HR systems and data initiatives. This role enhances employee experience through effective HR technology strategy, implementation, and governance while driving digital transformation and optimizing HR processes across the organization.

The Executive Director, Inflammation Marketing will lead the launch of Rocatinlimab, directing product strategy and promotional plans to achieve US sales goals. Responsibilities include team leadership, strategic direction, collaboration with Amgen, management of external agencies, and the continuous refinement of marketing strategies based on customer insights.