Senior Data Scientist, CMC

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $150k - $170k / year

⏰ Full Time

🟠 Senior

📊 Data Scientist

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• 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

• 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

• 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