Analytical Operations Specialist: Stability & Data

Biopharma Careers; Norwood (KY); On-site; USD 74,000 - 118,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning support

Generous paid time off

Equity opportunities

Job summary

Moderna is seeking an Analytical Technical Operations Specialist to support analytical execution across CMC Development, coordinating testing plans, stability studies, and data management. The role partners with scientists and cross‑functional teams to translate inputs into executable plans while aligning with program timelines.

The position is site‑based at Moderna and focuses on laboratory efficiency, data integrity, and digital tool implementation to enhance operational excellence in

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related scientific discipline.
• 3–6 years of experience in biotechnology, pharmaceuticals, analytical development, technical operations, or CMC Development.
• Experience supporting stability studies, analytical testing programs, or laboratory operations within a regulated environment.
• Experience working with LabVantage, Benchling, or similar Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN), or laboratory data management systems.
• Strong organizational, analytical, and problem‑solving skills with the ability to manage multiple priorities in a fast‑paced environment.
• Effective written and verbal communication skills with the ability to communicate technical information across functional teams.

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.
• Support the development and implementation of digital tools, automated workflows, and operational processes that improve laboratory efficiency and data quality.
• Assist with integrating laboratory and enterprise digital systems to improve planning, sample tracking, and analytical execution.
• Maintain accurate and compliant documentation while partnering with analytical scientists and technical teams to support successful execution of analytical activities.
• Identify opportunities for continuous improvement and participate in initiatives that enhance operational efficiency and data integrity.

Skills

Organizational skills

Analytical skills

Problem-solving

Education

Bachelor's degree in Chemistry

Tools

LabVantage

Benchling

Job description

Moderna is seeking an Analytical Technical Operations Specialist to support analytical execution across CMC Development, coordinating testing plans, stability studies, and data management. The role partners with scientists and cross‑functional teams to translate inputs into executable plans while aligning with program timelines.

The position is site‑based at Moderna and focuses on laboratory efficiency, data integrity, and digital tool implementation to enhance operational excellence in