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The Director of Mammalian Operations will lead a department of approximately 40 employees in the biopharmaceutical industry, ensuring regulatory compliance, managing talent, and driving continuous improvement in manufacturing operations. Responsibilities include overseeing production processes, strategic planning, and participating in regulatory inspections, all while fostering a strong team culture.

The Senior IT Application Architect will lead the design and implementation of functional solutions across ERP and CRM systems. The role focuses on integrating business processes with IT infrastructure, providing strategic advice on applications, and establishing standards that enhance operational excellence in alignment with AGC Biologics’ mission.

The Biologisch-Technischer Assistent (BTA) will support the production team by preparing and conducting fermentations, harvesting cells, and performing various filtration techniques, ensuring compliance with GMP standards, and assisting with equipment qualification and documentation processes.

The Cost Controller will oversee CSRD reporting, manage cost tracking and analysis, including profitability calculations, and support COGS and Reimbursed Revenue recognition. This role involves collaboration with various teams, financial audits, and improving reporting processes while ensuring accuracy and compliance with financial standards.

The Senior Scientist in the QA Mammalian team will ensure quality assurance for biopharmaceutical production, resolve quality issues, review and approve technical documents, support SOP development, collaborate with management on project issues, and assist in audits and quality agreements with clients.

The IT Application Specialist will manage configurations of PPM software, gather requirements, assist in testing and implementation, and create system documentation while collaborating with stakeholders. They will support integration with external applications and troubleshoot issues post-implementation, while also maintaining technical knowledge and best practices.

The Scientist in Quality Assurance - Systems will oversee supplier qualification, assist in audits and inspections, maintain and enhance the Quality Management System in compliance with GMP, manage documentation, ensure compliance during production, and handle deviations and regulatory processes.