Lead Process Validator Role:
This exciting opportunity involves leading process validation efforts for cell therapy manufacturing. The ideal candidate will have strong leadership skills and experience in biologics tech transfer and process validation.
Key Responsibilities:
* Drive process validation activities to meet regulatory requirements.
* Lead a team of process validation engineers to achieve best practices.
* Author validation documents and support regulatory submissions.
* Serve as a subject matter expert for audits, process improvements, and investigations.
Essential Requirements:
* Masters degree in a relevant field.
* Extensive experience in cell/gene therapy process validation.
* Strong leadership skills.
* Knowledge of GMP and regulatory requirements.
* Proficiency in English; additional language skills are beneficial.