Senior Data Scientist, CMC

The role

The Senior Data Scientist will build and deploy models, data products, and digital tools to support drug substance, drug product, packaging, and labeling processes. This role involves turning process and experimental data into actionable insights across small molecule and oligonucleotide programs.

What you will do

• Lead development, validation, and deployment of mechanistic, hybrid, and data-driven models.
• Partner with technical teams and CDMOs to translate process data into predictive models and analytics.
• Build analytics for drug product unit operations and packaging and labeling operations.
• Develop and maintain pipelines and FAIR data products within Databricks and related platforms.
• Develop dashboards and visualizations for technical and executive audiences.
• Serve as digital product owner for process modeling and technology-transfer analytics.
• Apply AI/ML to accelerate CMC data review and knowledge capture.
• Use forecasting, scenario analysis, and cost-benefit analysis to improve execution.
• Present recommendations to stakeholders and contribute to regulatory filings.
• Mentor colleagues in data science and modeling practices.

Required qualifications

• Master’s degree in Chemical Engineering, Pharmaceutical Sciences, Data Science, or a related scientific or engineering field, or Bachelor’s degree with equivalent experience.
• 5+ years of relevant experience in biotech/pharma process development, process engineering, or data science.
• Experience with process modeling, DoE, statistical analysis, and data-driven decision-making.
• Strong hands-on skills in Python and SQL.
• Experience using Databricks or comparable data platforms and BI/visualization tools such as Power BI, Tableau, or Spotfire.
• Working knowledge of cGMP, ALCOA+, CMC regulatory expectations, and GxP-validated computerized systems.
• Ability to solve ambiguous problems and communicate complex ideas clearly.
• Ability to work with self-direction and build trusted relationships across functions.

Nice to have

• Exposure to packaging and labeling operations
• Experience developing AI/ML applications and integrating AI-enabled tools into scientific or business workflows
• Experience supporting regulatory filings
• Experience working with CDMOs/CROs, external data flows, Agile ways of working, digital product ownership, or change management

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance, AD&D, and disability benefits
• Voluntary plans to personalize coverage
• 401(k) match up to 6%
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Extremely flexible wellness benefit
• Generous PTO
• Paid holidays
• Company-wide shutdowns

About the company

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company focuses on developing high impact medicines for patients and families affected by complex brain disorders.