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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.
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