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.
• Collaborate with cross‑functional partners to support forecasting activities, stage‑appropriate testing strategies, sample management, and development program planning.
• Design and implement digital tools, automated workflows, and operational processes that improve efficiency, enhance throughput, and support scalable analytical operations.
• Lead efforts to integrate new digital capabilities and improve connectivity between laboratory and enterprise systems, enabling more effective planning and execution.
• Maintain accurate and compliant documentation while partnering with analytical scientists and technical teams to support method understanding and successful execution of analytical activities.

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related scientific discipline.
• 6‑8 years of experience in biotechnology, pharmaceuticals, analytical development, technical operations, or CMC Development.
• Experience managing stability studies, analytical testing programs, or laboratory operations within a regulated environment.
• Experience working with Lab Vantage, Benchling, or similar laboratory information management (LIMS), electronic laboratory notebook (ELN), and data management systems.
• Strong project management, organizational, and problem‑solving skills with the ability to manage multiple priorities in a fast‑paced environment.
• Excellent written and verbal communication skills with experience presenting technical data to diverse stakeholders.

• Experience supporting mRNA, LNP, biologics, or other advanced therapeutic modalities.
• Knowledge of CMC Development, stability programs, and regulatory requirements supporting IND submissions and product development.
• Experience with process automation, workflow optimization, data visualization, or digital transformation initiatives.
• Demonstrated ability to analyze, trend, and interpret analytical data to support scientific and operational decision‑making.
• Experience leading or supporting cross‑functional programs and projects, including planning, prioritization, stakeholder management, risk mitigation, and execution against key milestones.

• Analytical Operations & Planning
• Stability Study Management
• Digital Systems & Automation
• Cross‑Functional Collaboration
• Project & Program Management
• Data Analysis &…