Sr. Scientist, CMC Quantitative Sciences

The Role:

Moderna is seeking a strategic, hands‑on Senior Scientist to join the CMC Quantitative Sciences (QS) team in Norwood, MA. As a key member of the team, you will serve as a statistical thought partner to Operations, Quality, Manufacturing Science and Technology, Analytical Development, and Technical Development organizations. You will be an integral part of advancing process monitoring and control tools, applying operational and predictive models, developing bespoke statistical analysis techniques, and innovating data products to solve critical business problems.

You will also support regulatory submissions and help shape Moderna’s statistical approach to multiple business problems across the product, platform, and analytical method lifecycle.

Beyond your technical contributions, you will mentor others and help build a culture of statistical excellence across CMC. This is an ideal role for someone who thrives in applied problem‑solving, enjoys coaching, and wants to make a tangible impact in a high‑paced, science‑first environment.

The ideal candidate is self‑driven, an excellent communicator, and aligned with Moderna’s core values of being Bold, Collaborative, Curious, and Relentless. Your leadership will help ensure our statistical approaches remain innovative, scalable, and essential to the success of our growing therapeutic platform.

Here’s

What You’ll Do:

• Lead statistical support for analytical method and/or product lifecycle activities, including pre‑pivotal, clinical, and commercial programs

• Serve as a subject matter expert on statistical aspects of research and CMC activities, guiding experimental design, data analysis, and decision‑making

• Contribute to regulatory filings by authoring and reviewing statistical content for items such as comparability, analytical methods, stability, in regulatory submissions

• Drive analytical monitoring innovation by developing automated data monitoring systems and integrating industry best practices in product and analytical lifecycle activities

• Partner cross‑functionally with scientists, engineers, and quality teams to ensure experiments are well‑designed and statistical methods are appropriately applied

• Educate partners by building statistical literacy and promoting the use of sound statistical reasoning in decision‑making

• Communicate clearly to both technical and non‑technical audiences, translating complex analyses into actionable insights

• Champion statistical best practices to promote consistency, rigor, and scalability across CMC QS and the broader Moderna platform

• Stay current and contribute to the field through literature review, training, and conference engagement

Here’s What You’ll Bring to the Table:

Minimum Qualifications

• PhD in Statistics (2+ yrs), MS (8 - 10 yrs), or BS (10 - 15 yrs) in Statistics, Biostatistics, Data Science, Applied Mathematics, Chemical Engineering, Biochemical Engineering, or a related STEM discipline.

• Strong foundation in applied statistical methods such as DOE, regression, capability analysis, control charts, and multivariate analysis

• Experience with analytical method lifecycle and/or product development lifecycle activities in a regulated environment

• Demonstrable experience with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data

• Effective communicator who can translate statistical thinking into actionable strategies for non‑statistical audiences

• Understanding of regulatory guidance (e.g., ICH, FDA, EMA, WHO)

Preferred Qualifications

• Familiarity with eCTD submissions and response to HA questions

• Experience with analytical QC automation, high‑throughput methods, or large‑scale monitoring systems

• Knowledge of phase‑appropriate GMP…