Roles & Responsibilities

Primary Objective / Purpose

To drive the deep scientific understanding and advanced statistical analysis underlying production processes.

Key Responsibilities

* Lead advanced process characterization studies.

* Utilize data science and statistical analysis for process optimization.

* Drive the statistical evaluation of PPQ batches.

* Engineer mathematical process models and predictive analytics tools.

* Provide scientific rationale for regulatory process validation.

Key Deliverables

* Process characterization reports

* Statistical process control models

* Process validation strategies

Required Skills & Qualifications

* Master’s or Ph.D. in Bio/Chemical Engineering or Life Sciences.

* Advanced scientific troubleshooting and root cause analysis skills.

* Proficiency in statistical modeling and DoE.

* Hands-on laboratory scale-down model experience.