Quantitative CMC Scientist - Data & Modeling Specialist

BioSpace

Norwood (MA)

On-site

USD 109,000 - 175,000

Full time

6 days ago
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Job summary

Moderna seeks a hands‑on Scientist to join the CMC Quantitative Sciences team in Norwood, MA. You will partner with scientists, engineers, manufacturing, analytical, quality, regulatory, and digital teams to solve problems using quantitative methods across product and process lifecycles.

The role emphasizes leadership of analyses, reproducible code, regulatory‑readiness, and building reusable analytical solutions with senior mentorship. Onsite at our Norwood site.

Qualifications

  • PhD (0 - 2 yrs), MS (5 - 8 yrs), or BS (8 - 10 yrs) in Statistics, Biostatistics, Data Science, Applied Mathematics, Chemical Engineering, Biochemical Engineering, or a related STEM discipline.
  • Demonstrated depth in at least one quantitative area, such as applied statistics, machine learning or predictive modeling, data science, mechanistic modeling, data engineering, or digital analytics solutions.
  • Experience independently selecting and applying quantitative methods to moderately complex scientific, technical, or operational problems.
  • Proficiency with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data.
  • Ability to lead defined assignments or small to mid‑sized workstreams, manage competing priorities, and deliver high‑quality work within agreed timelines.
  • Understanding of regulatory guidance (ICH, FDA, EMA, WHO).

Responsibilities

  • Independently plan and execute moderately complex quantitative analyses, models, or data solutions that support research, development, manufacturing, analytical, quality, and product lifecycle decisions.
  • Translate scientific and business questions into clear analytical objectives; identify data requirements, select appropriate methods, assess assumptions and limitations, communicate conclusions, and recommended next steps.
  • Apply quantitative methods suited to the problem, including statistics, machine learning, mechanistic modeling, data science, and data engineering.
  • Lead defined projects or workstreams with manageable risk and resource requirements; establish plans, coordinate contributors, manage timelines, identify dependencies, and elevate technical or delivery risks early.
  • Partner directly with cross‑functional scientists, engineers, manufacturing, analytical, quality, regulatory, and digital teams to ensure studies and analyses are appropriately designed and results are translated into practical decisions.
  • Develop reproducible and traceable analyses, models, code, visualizations, reports, and technical documentation aligned with team standards and phase‑appropriate GxP expectations.
  • Contribute quantitative content and supporting analyses for technical reports, regulatory submissions, responses to health authority questions, and other controlled documents, with senior leader review as appropriate.
  • Build, improve, or apply reusable methods, scripts, templates, dashboards, pipelines, and analytical tools that increase the consistency, scalability, and efficiency of CMC decision‑making.
  • Evaluate data quality and analytical readiness; work with data owners and partners to resolve gaps, document assumptions, and improve data practices at the source.
  • Communicate complex technical and scientific information clearly to technical and non‑technical audiences, including difficult findings, uncertainty, tradeoffs, and limitations.
  • Provide informal mentoring and technical guidance to less‑experienced colleagues; contribute to peer review, knowledge sharing, training, and continuous improvement within CMC QS.
  • Stay current with relevant quantitative methods, digital technologies, regulatory expectations, and industry practices; introduce new approaches when they provide clear scientific or business value.

Skills

Applied statistics
Machine learning
Data science
Mechanistic modeling
Data engineering
Python
R
SQL
Communication

Education

PhD
MS in Statistics/Data Science
BS in STEM

Tools

R
Python
SQL
JMP
Statistica
Minitab

Job description

Moderna seeks a hands‑on Scientist to join the CMC Quantitative Sciences team in Norwood, MA. You will partner with scientists, engineers, manufacturing, analytical, quality, regulatory, and digital teams to solve problems using quantitative methods across product and process lifecycles.

The role emphasizes leadership of analyses, reproducible code, regulatory‑readiness, and building reusable analytical solutions with senior mentorship. Onsite at our Norwood site.

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