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Senior Data Scientist, CMC
Praxis. Build, validate, and deploy mechanistic, hybrid, and data-driven models supporting drug substance, drug product, packaging, labeling, technology transfer, and manufacturing processes.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in process modeling, data-driven decision-making, and analytics within the biotech and pharmaceutical sectors, with a strong foundation in Python, SQL, and data visualization tools. Proven ability to collaborate across functions and mentor colleagues while adhering to regulatory standards and driving technology transfer initiatives.
Highest-signal resume keywords
Process ModelingData-Driven Decision-MakingPython ProgrammingSQL ProficiencyDatabricks Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process DevelopmentStatistical AnalysisPredictive ModelingScenario AnalysisCost-Benefit AnalysisAI/ML ApplicationData Integrity ControlsForecastingDoECGMP Knowledge
Soft Skills
Problem SolvingClear CommunicationSelf-DirectionRelationship BuildingIntellectual Curiosity
Tools & Technologies
DatabricksPower BITableauSpotfireGxP-Validated Systems
Industry Keywords
BiotechPharmaceuticalCMC Regulatory ExpectationsALCOA+Technology Transfer
Tech Stack
Tools & technologiesPythonSQLTableau
About the role
Key responsibilities & impact- Build, validate, and deploy mechanistic, hybrid, and data-driven models supporting drug substance, drug product, packaging, labeling, technology transfer, and manufacturing processes.
- Translate DoE, PAT, IPC, batch record, and other process data into predictive models and analytics that inform process understanding, control strategy, risk assessment, and phase-appropriate decisions.
- Build analytics for blending, granulation, compression, coating, fill/finish, packaging, and labeling operations, including yield, throughput, readiness, and supply-chain scenario analysis.
- Develop and maintain pipelines and FAIR data products integrating internal and CRO/CDMO data into traceable, reusable datasets 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, defining priorities and driving adoption.
- Apply AI/ML, including agentic workflows and LLM-based tools, to accelerate CMC data review, knowledge capture, and routine analytical work with validation and data-integrity controls.
- Use forecasting, scenario analysis, and cost-benefit analysis to improve right-first-time execution and shorten technology-transfer timelines.
- Present recommendations to stakeholders, contribute to CMC data science strategy and regulatory filings, and mentor colleagues in data science and modeling practices.
- Collaborate with Engineering, Process Chemistry, Formulation, Analytical Development, Quality, Data Science, and external CDMOs.
Requirements
What you’ll need- Master’s degree in Chemical Engineering, Pharmaceutical Sciences, Data Science, or a related scientific or engineering field, with demonstrated application of data science to process development; Bachelor’s degree with equivalent experience will be considered.
- 5+ years of relevant experience in biotech/pharma process development, process engineering, or data science, ideally supporting drug substance and/or drug product development or technology transfer.
- 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.
- Demonstrated ability to solve ambiguous problems, communicate complex ideas clearly, work with self-direction, and build trusted relationships across functions.
- Intellectual curiosity, creativity, innovation, organization, attention to detail, and a strong bias toward high-quality results.
- Willingness and flexibility to travel as needed.
Benefits
Comp & perks- 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
- Dollar-for-dollar 401(k) match up to 6% on eligible contributions
- Long-term stock incentives and ESPP
- Discretionary quarterly bonus
- Extremely flexible wellness benefit
- Generous PTO
- Paid holidays
- Company-wide shutdowns