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Praxis
Praxis
11 – 50 Angajați
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Praxis este o companie de servicii medicale și consultanță care ajută la conectarea pacienților cu oportunități de participare la studii clinice. Fondată în 2002, compania dezvoltă programe personalizate de recrutare pentru studii din diverse arii terapeutice, combinând instrumente specializate, strategii de implicare a pacienților și informații bazate pe date pentru a identifica participanți potriviți la nivel global și pentru a sprijini o experiență mai bine informată a pacienților pe parcursul cercetării clinice.
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Locurile de muncă ale companiei

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.

USStatele Unite ale Americii
150.000 $ – 170.000 $ / an
RemoteNormă întreagăSeniorLimbă Obligatorie: englezăSpecialist în știința datelor
PythonSQLTableau

Descriere

  • 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.

Cerințe

  • 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.

Beneficii

  • 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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