Senior Data Scientist, CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, validate, and implement mechanistic, hybrid, and data-driven models that support drug substance, drug product, packaging, labeling, technology transfer, and manufacturing processes.

• Convert DoE, PAT, IPC, batch record, and other process data into predictive models and analytics that enhance process understanding, control strategies, risk assessments, and phase-appropriate decision-making.

• Create analytics for operations such as blending, granulation, compression, coating, fill/finish, packaging, and labeling, focusing on yield, throughput, readiness, and supply-chain scenario analyses.

• Design and maintain pipelines and FAIR data products that integrate internal and CRO/CDMO data into traceable, reusable datasets using Databricks and related platforms.

• Construct dashboards and visualizations tailored for both technical and executive audiences.

• Act as the digital product owner for process modeling and technology-transfer analytics, establishing priorities and fostering adoption.

• Utilize AI/ML techniques, including agentic workflows and LLM-based tools, to expedite CMC data review, knowledge capture, and routine analytical tasks while ensuring validation and data integrity controls.

• Implement forecasting, scenario analyses, and cost-benefit evaluations to enhance right-first-time execution and reduce technology-transfer timelines.

• Provide recommendations to stakeholders, contribute to CMC data science strategies and regulatory submissions, and mentor colleagues in data science and modeling methodologies.

• Collaborate with teams in 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 discipline, with proven experience applying data science to process development; a Bachelor’s degree with equivalent experience will also be considered.

• Over 5 years of relevant experience in biotech/pharma process development, process engineering, or data science, preferably in support of drug substance and/or drug product development or technology transfer.

• Proficiency in process modeling, DoE, statistical analysis, and data-driven decision-making.

• Strong practical skills in Python and SQL.

• Familiarity with Databricks or similar data platforms and BI/visualization tools such as Power BI, Tableau, or Spotfire.

• Understanding of cGMP, ALCOA+, CMC regulatory expectations, and GxP-validated computerized systems.

• Proven ability to tackle ambiguous problems, articulate complex ideas clearly, work independently, and cultivate trusted relationships across functions.

• Demonstrated intellectual curiosity, creativity, innovation, organizational skills, attention to detail, and a strong commitment to high-quality outcomes.

• Willingness and flexibility to travel as required.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision plans.

• Company-funded life insurance, AD&D, and disability coverage.

• Optional plans to customize coverage.

• Dollar-for-dollar 401(k) match up to 6% on eligible contributions.

• Long-term stock incentives and Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonuses.

• Highly flexible wellness benefits.

• Generous paid time off (PTO).

• Paid holidays.

• Company-wide shutdowns.