Principal Scientist, Bioanalytical & Molecular Assays

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About the role

The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. As a Senior Project Specialist, Clinical Supplies, you will play a critical role in ensuring the successful operational execution of clinical supply activities across Moderna’s clinical development portfolio. Supporting multiple therapeutic area teams, you will work closely with Clinical Supply Project Managers, CROs, packaging and labeling vendors, and IRT providers to ensure investigational products are delivered to patients and sites efficiently, compliantly, and on schedule. This is a highly collaborative individual contributor role requiring exceptional attention to detail, strong organizational skills, and the ability to coordinate across internal and external stakeholders. You will help drive seamless clinical supply operations while contributing to process improvements, digital innovation, and the adoption of advanced technologies that enhance supply chain visibility and execution. Here's What You'll Do: • Support Clinical Supply Project Managers in facilitating operational activities required for the labeling, packaging, distribution, and shipment of clinical drug supplies to depots and investigative sites. • Coordinate activities associated with additional clinical supplies required to support study execution. • Partner with packaging and labeling vendors, IRT vendors, CROs, and internal cross-functional stakeholders to support study-specific supply requirements. • Execute User Acceptance Testing (UAT) for Interactive Response Technology (IRT) systems and support system readiness activities. • Monitor inventory levels and distribution activities to ensure uninterrupted clinical supply availability. • Track and oversee packaging, labeling, and distribution activities performed by third-party vendors, escalating risks and operational issues as necessary to maintain study timelines and objectives. • Execute activities in accordance with Moderna Standard Operating Procedures (SOPs), quality requirements, and applicable regulatory expectations. • Maintain strong collaborative relationships with third-party vendors to ensure planning activities remain aligned with operational execution and quality compliance. • Monitor and track shipments to depots and clinical sites while proactively troubleshooting logistics challenges and escalating issues when required. • Receive, assess, document, and manage temperature excursions, coordinating investigations and resolution activities as appropriate. • Assist in oversight activities performed by third-party vendors, including: • Procurement activities • Labeling performance • On-time delivery performance • Quality monitoring • Continuous improvement initiatives • Issue identification and resolution • Support the development of pharmacy manuals in partnership with relevant cross-functional stakeholders. • Assist in developing drug supply training materials for investigational sites to support effective study execution. • Participate in departmental initiatives focused on improving processes, systems, operational efficiency, and scalability. • Contribute to a culture of continuous improvement by identifying opportunities to streamline workflows and strengthen operational execution. • Utilize digital tools and emerging technologies, including opportunities to work alongside AI-enabled solutions, to enhance planning, visibility, and decision-making across clinical supply operations. The key Moderna Mindsets you’ll need to succeed in the role: • We obsess over learning. We don’t have to be the smartest we have to learn the fastest. • We digitize everywhere possible using the

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