Process Scientist / Data Manager

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.