Search the 28 jobs at Kyowa Kirin

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 Employee Relations Specialist will support HR business partners by managing employee inquiries, conducting investigations into complaints, implementing HR policies and procedures, and promoting a positive workplace culture. They will assist with talent management and provide recommendations on performance issues, while ensuring compliance with labor laws.

As the Manufacturing Site IT Infrastructure Lead, you'll manage IT infrastructure at a new manufacturing site, ensuring operational alignment with enterprise standards. Responsibilities include overseeing network operations, server administration, security, and supporting manufacturing automation systems, along with strategic IT planning and compliance with industry standards.

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 Sr. Manager – Environment, Health, and Safety will provide leadership for safe drug manufacturing practices, develop safety policies and training programs, ensure regulatory compliance, conduct safety audits, and manage incident investigations. This role also focuses on team development and fostering a collaborative environment within the organization.

The Research Associate in Process Development will support cell therapy projects, develop and optimize processes, conduct laboratory experiments, analyze data, ensure regulatory compliance, and collaborate with teams on process improvements. This role also involves documentation preparation and presentations of research findings.

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 Senior Specialist will ensure compliance with 21 CFR Part 11 and Data Integrity for GMP computerized systems during design and lifecycle management in a new monoclonal antibody drug manufacturing facility. This role involves leadership in quality systems, operational readiness, data integrity compliance, and collaboration with cross-functional teams during facility start-up and tech transfer activities.

The Specialist II, Quality Systems and Compliance ensures compliance with regulations for GxP computerized systems during design and lifecycle management. Responsibilities include implementing Quality Systems, collaborating cross-functionally, and ensuring adherence to Data Integrity and risk management procedures. The role is involved in operational readiness and inspection management within manufacturing for Phase III and early commercial products.

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 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.

Interns will assist in the ICT Infrastructure and Operations team, building ATF test suites for ServiceNow applications, gathering requirements, performing testing, maintaining documentation, and providing support for ServiceNow-related queries. Experience in a customer service role and understanding Agile methods are preferred.

The Senior Process Engineer is responsible for the design, commissioning, and operation of the manufacturing facility, focusing on process optimization, documentation approval, and compliance with operational readiness and audits. This role demands collaboration across teams to support new product evaluations and maintain system ownership within processing areas.

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 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.

As a Quality Assurance Intern, you will assist the Quality Assurance team with tasks related to pre-approval inspections (PAI), including document preparation, migration tasks, and collaboration with various departments to ensure document accuracy and availability. This position provides a broad understanding of the pharmaceutical industry and cGMPs.

The intern will support IT capabilities within Supply Chain Manufacturing and Corporate Functions by troubleshooting technical issues, providing business analysis for IT projects, enhancing reporting with PowerBI, and facilitating system architecture designs. They will also communicate project status and identify opportunities for system enhancements.