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Leading the design and implementation of digital systems for the production of Individualized Neoantigen Therapies. Collaborating with various teams to optimize processes and support automation in pharmaceutical/biotechnology manufacturing and lab systems.
In this role at Moderna, you will ensure compliance with regulatory standards in the supply chain operations at the Laval site. Key responsibilities include managing documentation, reviewing Standard Operating Procedures (SOPs), supervising training modules, and coordinating export control for shipments. You'll collaborate with warehouse teams to maintain efficient operations and respond swiftly to deviations, contributing to Moderna's mission of delivering vital medications globally.
The Sr. Manager, GxP Documentation Control oversees GxP documentation and records management, ensuring compliance with regulatory requirements. Responsibilities include providing strategic direction, managing internal processes, leading training programs, and improving documentation standards. The role involves collaboration with digital partners, metrics development, and fostering a positive work culture.
The Sr. Specialist in Master Data Management will develop and implement strategies for the integrity and accuracy of master data assets. Responsibilities include overseeing MDM systems, defining data governance standards, collaborating with cross-functional teams, and ensuring high-quality data management practices while reporting progress to senior leadership.
The Senior Systems Engineer will lead the design and deployment of Environmental, Health, & Safety systems. Responsibilities include creating functional specifications, overseeing system architecture, evaluating software, and ensuring business continuity of EHS solutions, while also documenting processes.
Join an innovative team revolutionizing medicine through mRNA technology. Seeking a Principal Site Network Engineer with experience in implementing and maintaining a global network for highly available manufacturing sites in a hybrid cloud environment. Responsibilities include managing network infrastructure, working with vendors, ensuring network management controls, and providing technical support.
The Sr. Manager at Moderna will coordinate and manage all Chemistry, Manufacturing & Controls (CMC) activities related to product launch. Responsibilities include liaising between CMC functions, identifying strategies for timely launch, collaborating with cross-functional teams, managing risks in the vaccine launch process, and ensuring adherence to regulatory standards.
As a Principal Incident Response Analyst, you will lead incident response initiatives, manage critical security incidents, refine processes, and collaborate with cross-functional teams to enhance cybersecurity measures. You will also develop IR playbooks, direct team activities, and interact with C-Suite, focusing on continuous improvement of incident management.
The Sr. Specialist, Customer Engagement will support Moderna's Vaccines commercial organization by overseeing customer engagement activities, ensuring compliance and risk management, analyzing customer data, and enhancing internal strategies through data analytics. This role focuses on expanding Moderna's presence in new markets and aligning activities with mRNA technology initiatives.
The Principal Statistician leads the CMC Statistics team, providing strategic statistical guidance, mentoring, and fostering statistical excellence. Responsibilities include consultation on research questions, collaboration with cross-functional teams, contributing to regulatory filings, and enhancing platforms using Quality by Design principles. The role emphasizes driving a culture of data-driven decision-making and education on statistical tools across the organization.
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