Search the 43 jobs at Kyowa Kirin

The Sr. Manager, Business Operations at Kyowa Kirin will oversee financial management of clinical trials, including vendor contract management and budget forecasting. This role requires financial analysis to support project teams, vendor selection process involvement, and maintaining vendor performance reporting.

Join Kyowa Kirin for a paid summer internship as a Human Resources Intern. Responsibilities include project planning, leadership & development projects, ad-hoc HR projects/reporting, assisting various HR functions, driving HR initiatives, performing audits, and staying updated on industry trends and regulations.

The Specialist II will ensure compliance with 21 CFR Part 11 and Data Integrity requirements for the cGxP computerized systems at Kyowa Kirin's new manufacturing facility. Responsibilities include implementing Quality Systems, collaborating cross-functionally, leading risk management processes, and ensuring timely compliance during the facility startup and operations.

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 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 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.

As the Manufacturing Site IT Infrastructure Lead at Kyowa Kirin, responsible for planning, implementing, and managing IT infrastructure at a new manufacturing site. Ensure infrastructure aligns with site objectives and enterprise standards. Lead network operations, server administration, security, end-user support, and more.

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 intern will support Project Managers in drug development projects, participate in creating deliverables, assist in risk assessments, compile data, and communicate project updates. The role focuses on learning project management fundamentals and applying skills in a pharmaceutical context.

As a Patient Services intern, you will support the Patient Services team with marketing material creation, collect and analyze feedback, assist in training development, and undertake a research project in the patient services industry. You will engage in various tasks to drive impact in rare disease areas.

The internship involves supporting the Information Security team with monitoring, incident response, IT compliance, drafting InfoSec policies, documenting processes, building performance dashboards, and enhancing internal communications while working in a hybrid 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 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 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 Procurement Summer Intern will support the procurement team by conducting spend analysis, participating in vendor risk management, leading sourcing projects, and negotiating with vendors. This role provides hands-on experience in the Source-to-Pay process, project management, and collaboration with internal stakeholders to enhance procurement strategies.

The EQV/CSV Lead Engineer will oversee the Commissioning, Qualification, and Verification of the NC Manufacturing Facility, leading the establishment of the EQV/CSV program, and ensuring successful execution with project leads to achieve OQ completion by Q1 2027.

Intern will support Kyowa Kirin's Supply Chain Department, focusing on logistics by enhancing reporting practices using data analytics, engaging with 3rd Party Logistics providers, and identifying documentation voids in logistics processes to optimize supply chain efficiency.