Senior Specialist, Analytical Technical Operations

The Role

The Individual is responsible for enabling efficient analytical execution across CMC Development programs through strategic planning, stability study management, and digital operations support. This role serves as a key operational partner, translating inputs from multiple laboratory and business systems into executable testing plans while ensuring analytical activities are aligned with program priorities, timelines, and development objectives.

Working across Analytical Development, Process Development, and other CMC functions, the Candidate drives operational excellence through process optimization, automation, and digital integration initiatives. The role combines scientific understanding, project coordination, and data-driven decision-making to support stability programs, accelerate development timelines, and deliver high-quality analytical data that informs critical product development and regulatory decisions.

• Develop and maintain integrated analytical testing schedules by consolidating inputs from multiple digital systems, program priorities, and laboratory capacity to support CMC Development activities.
• Author, review, and manage stability protocols and studies for novel mRNA and Lipid Nanoparticle (LNP) drug candidates, supporting shelf-life determination, IND-enabling studies, and product development milestones.
• Generate, review, trend, and interpret analytical data; perform peer data review; prepare technical summaries and data packages; and communicate results and recommendations to stakeholders across CMC Development.
• Manage multiple program timelines simultaneously, ensuring testing milestones, study deliverables, and reporting commitments are completed on schedule.