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Senior CMC Data Scientist — United States Remote
Lead data science for CMC process development at Praxis, building mechanistic models, FAIR data products, and AI-enabled tools for a clinical-stage CNS biopharmaceutical company. Use analytics to improve drug development and technology-transfer decisions.
विवरण
- Create, validate, and deploy mechanistic, hybrid, and data-driven models for drug substance, drug product, packaging, labeling, technology transfer, and manufacturing.
- Convert DoE, PAT, IPC, batch-record, and related process data into predictive analytics that support process understanding, control strategies, risk evaluation, and phase-appropriate decisions.
- Develop analytics for blending, granulation, compression, coating, fill/finish, packaging, and labeling, covering yield, throughput, readiness, and supply-chain scenarios.
- Build and maintain pipelines and FAIR data products that combine internal and CRO/CDMO data into traceable, reusable datasets in Databricks and related platforms.
- Create dashboards and visualizations tailored to technical teams and executive stakeholders.
- Own the digital product roadmap for process modeling and technology-transfer analytics, setting priorities and supporting adoption.
- Use AI and machine learning, including agentic workflows and LLM-based tools, to accelerate CMC data review, knowledge capture, and recurring analysis under validation and data-integrity controls.
- Apply forecasting, scenario modeling, and cost-benefit analysis to improve right-first-time execution and reduce technology-transfer timelines.
- Present recommendations, support CMC data science strategy and regulatory submissions, and mentor colleagues in data science and modeling methods.
- Partner with Engineering, Process Chemistry, Formulation, Analytical Development, Quality, Data Science, and external CDMOs.
आवश्यकताएँ
- Master’s degree in Chemical Engineering, Pharmaceutical Sciences, Data Science, or a related scientific or engineering discipline, with demonstrated data science application in process development; equivalent experience with a bachelor’s degree may also qualify.
- At least five years of relevant experience in biotech or pharmaceutical process development, process engineering, or data science, ideally involving drug substance or drug product development or technology transfer.
- Practical experience with process modeling, design of experiments, statistical analysis, and data-informed decision-making.
- Advanced hands-on ability with Python and SQL.
- Experience with Databricks or a comparable data platform, plus business intelligence and visualization tools such as Power BI, Tableau, or Spotfire.
- Working knowledge of cGMP, ALCOA+, CMC regulatory expectations, and GxP-validated computerized systems.
- Ability to navigate ambiguous problems, explain complex concepts clearly, work independently, and build strong cross-functional relationships.
- Curiosity, creativity, innovation, organization, close attention to detail, and a consistent focus on high-quality outcomes.
- Flexibility to travel when needed.
लाभ
- The company covers 99% of medical, dental, and vision plan premiums.
- Company-paid life insurance, AD&D, and disability coverage.
- Voluntary plans allow employees to customize their coverage.
- Dollar-for-dollar 401(k) matching is available on eligible contributions up to 6%.
- Long-term stock incentives and an employee stock purchase plan.
- Discretionary quarterly bonus opportunity.
- Highly flexible wellness benefit.
- Generous paid time off.
- Paid holidays.
- Company-wide shutdown periods.
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