Senior Manager, MSAT

Ensure successful technology transfer and process validation of Moderna processes at internal and external drug product manufacturing sites.,Lead cross-functional project teams for new product introductions and continuous process improvement.,Develop and maintain comprehensive documentation for process validation and technical transfer.,Act as the primary technical contact for validation-related investigations, including root cause analysis and corrective action planning.,Create and manage change controls for new product introductions, adhering to Moderna's Quality Systems.,Drive alignment across Moderna manufacturing sites through knowledge sharing, data exchange, and harmonized solutions.,Support regulatory submissions and respond to queries from health authorities related to process validation.,Represent the MSAT function during regulatory audits, ensuring inspection readiness and compliance.,Implement industry best practices and continuous improvement methodologies in technical transfer and validation activities.,Facilitate risk assessments and mitigation strategies across stakeholders.,Promote a culture of safety, collaboration, and innovation.

Education: Science Degree with pharmaceutical/biotechnology applicability (pharmacy, chemistry, biotechnology, engineering, etc.).,Experience: Minimum of 10 years in the pharmaceutical/biotechnology industry.,Experience with cGMP manufacturing, drug product technical transfer, and process validation.,Knowledge of drug product manufacturing, including formulation, sterile filtration, aseptic processing, visual inspection, labeling, and packaging.

Bachelor's Degree

Employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law.,Only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.,Moderna is a smoke-free, alcohol-free, and drug-free work environment.