Search the 26 jobs at Kyowa Kirin

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.

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 Quality Assurance intern will assist with creating and reviewing SOPs, researching QC equipment, and configuring systems such as LIMS, Empower, and ELN as part of the biologics manufacturing facility project.

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 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 Manager of Patient Services Training and Development designs and facilitates training solutions for the Patient Services department, collaborating with key stakeholders to address knowledge gaps and enhance employee performance. They manage vendor relationships, develop training materials, and report on program effectiveness.

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 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 Director of Global Procurement will lead procurement projects, ensuring compliance with policies and regulations while managing relationships with suppliers. Responsibilities include overseeing sourcing negotiations, developing procurement strategies, and identifying cost-saving opportunities. This role requires high-level negotiations and data analysis to enhance procurement operations.

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 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. 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 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 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 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 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.