Analytical Operations Lead – Digital & Stability Programs

RXinsider LTD.; Norwood (MA); Hybrid; USD 90,000 - 144,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Job summary

Moderna, based in the United States, seeks a skilled Operations lead to enable efficient analytical execution across CMC Development programs, including stability studies and digital operations support.

You will drive integration of laboratory and enterprise systems, manage complex testing schedules, and partner with cross-functional teams to meet program milestones and regulatory needs. The role emphasizes data-driven decision-making and scalable analytics.

Qualifications

• 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 LabVantage, 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.

Responsibilities

• 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.

Skills

Analytical Operations

Stability Study Management

Digital Systems & Automation

Cross-Functional Collaboration

Project & Program Management

Data Analysis & Reporting

Scientific Problem Solving

Technical Communication

Education

Bachelor's degree in Chemistry or related

Tools

LabVantage

Benchling

LIMS/ELN systems

Job description

Moderna, based in the United States, seeks a skilled Operations lead to enable efficient analytical execution across CMC Development programs, including stability studies and digital operations support.

You will drive integration of laboratory and enterprise systems, manage complex testing schedules, and partner with cross-functional teams to meet program milestones and regulatory needs. The role emphasizes data-driven decision-making and scalable analytics.