Specialist, Analytical Technical Operations

About the role

The Specialist, Analytical Technical Operations (ATO) supports analytical execution across CMC Development programs through testing coordination, stability study management, and digital operations support. This role partners with analytical scientists and cross-functional teams to translate inputs from laboratory and business systems into executable testing plans while helping ensure analytical activities align with program priorities and development timelines. Working across Analytical Development, Process Development, and other CMC functions, the Specialist contributes to operational excellence by supporting process improvements, digital workflows, and data management activities. The role combines scientific knowledge, project coordination, and analytical operations to support stability programs, improve laboratory efficiency, and deliver high-quality analytical data that enables product development decisions.

Responsibilities

• Coordinate and maintain analytical testing schedules by consolidating inputs from digital systems, program priorities, and laboratory capacity to support CMC Development activities.
• Support the authoring, execution, and maintenance of stability protocols and studies for novel mRNA and Lipid Nanoparticle (LNP) drug candidates in support of shelf-life determination, IND-enabling studies, and product development milestones.
• Compile, review, trend, and summarize analytical data; perform peer data review; prepare technical summaries and data packages; and communicate results to cross-functional stakeholders.
• Coordinate multiple program timelines simultaneously to help ensure testing milestones, study deliverables, and reporting commitments are completed on schedule.
• Partner with cross-functional teams to support forecasting activities, stage-appropriate testing strategies, sample management, and development program planning.