PrincipalResearchAssociate,AnalyticalDevelopment

**The Role:** In this role, you will primarily focus on managing the analytical control strategy to support large-scale process development and optimization for plasmid DNA, cell-free DNA and enzymes. Responsibilities include driving analytical control strategies and associated deliverables, such as test method development, optimization, pre-qualification, qualification, and validation; specification setting; and the timely initiation of IPC, release, characterization testing and stability studies. The role will also support investigations related to release and stability data. You are expected to work in a highly collaborative, cross-functional team environment, and interface with different departments as well as technical and operational teams. The individual must thrive in a fast-paced environment with high expectations. Integrity, ability to pay attention to detail and troubleshoot, curiosity, collaborative spirit, respect for people, exemplary work ethic and setting the bar high are key values to thrive in this team. This role is located at the Moderna Technology Center in Norwood, MA. **Here’s What You’ll Do:** * Partner closely with the Analytical Program Lead for DNA and Enzymes to drive analytical control strategies that support large-scale process development and optimization for plasmid DNA, cell-free DNA, and enzymes. * Develop and maintain tracking systems to monitor analytical deliverables, including test method development, optimization, pre-qualification, qualification, and validation; specification setting; and timely initiation of IPC, release, characterization testing, and stability studies. * Collaborate with cross-functional stakeholders to ensure timely procurement and availability of analytical testing materials * Support investigations of out-of-specification (OOS) and out-of-trend (OOT) results in collaboration with Analytical Development SMEs, Analytical Technical Operations, and Quality, as needed. * Generate high-quality technical documen