Statistics & Process Analytical Technology Expert

Tasks

• Apply ANOVA
• Apply chemometrics for spectral preprocessing
• Apply multivariate data analysis
• Apply partial least squares
• Apply principal component analysis
• Apply regression analysis
• Assess pharmaceutical quality attributes
• Conduct deviation investigations
• Define and deploy PAT strategies
• Deliver statistical training
• Design experiments using design of experiments
• Develop multivariate calibration models
• Develop multivariate control charts
• Develop release limits
• Develop stability models
• Evaluate process capability
• Implement real time release testing
• Lead PAT solution development
• Monitor process performance
• Perform dissolution similarity assessment
• Perform equivalence testing
• Perform risk assessment
• Provide statistical subject matter expertise
• Support PAT model transfer and robustness
• Support multivariate process control
• Support ongoing process verification
• Support quality by design
• Support regulatory submissions and inspections
• Support root cause investigations
• Support scientific decision making
• Validate and implement PAT solutions

Perks/Benefits

• Hybrid work

Skills/Tech-stack

ANOVA | By Design | Capability analysis | Chemometrics | Component analysis | Control Charts | Data Analysis | Design of Experiments | Dissolution Similarity Assessment | Equivalence Testing | GMP | Least-squares) | Model transfer | Multivariate Control Charts | Multivariate Data | Multivariate Data Analysis | Multivariate Model Transfer | Multivariate calibration | Ongoing Process Verification | Partial Least Squares | Principal Component Analysis | Process Capability | Process Capability Analysis | Process Verification | Process control | Quality by Design | Real Time | Real Time Release Testing | Regression Analysis | Release testing | Similarity assessment | Statistical Process Control | Statistics