- Gaithersburg, Maryland, United States
- Full-time · Senior
- $102K–$152K per year
- 2+ years
Develop and maintain analytical workflows for multivariate process monitoring, predictive modeling, and anomaly detection on high-dimensional process data, building AI-enabled tooling and data systems.
Compensation
The annual base pay (or hourly rate of compensation) for this position ranges from $101,643.20 - $152,464.80.
Responsibilities
- Support statistical analysis for comparability assessments (site transfers, significant process changes), process characterization, and control strategy development for cell therapy programs
- Apply rigorous statistical frameworks (equivalence testing, process capability analysis, variance component analysis, tolerance intervals) to evaluate drug product quality and support defensible regulatory narratives
- Design and analyze DOE studies for process characterization and LVV manufacturing, including risk-based parameter selection and interaction modeling
- Support process and product characterization for early development activities
- Develop and maintain process monitoring workflows for pivotal and commercial manufacturing, including statistical control charts, alert/action limits, and trend detection
Requirements
- Ph.D. in Chemical Engineering
- Biochemical Engineering
- Biotechnology
- Data Science
- Statistics