Job Description
We are seeking a skilled leader to oversee process validation activities for clinical and commercial cell therapy manufacturing.
About the Role
The ideal candidate will lead a team of process validation engineers, driving best practices in CAR-T manufacturing. This role requires strong leadership experience and deep knowledge of GMP, biotherapeutics process validation, and regulatory requirements.
Responsibilities
- Oversee all process validation activities, ensuring compliance with regulatory requirements.
- Lead a team of process validation engineers, driving best practices in CAR-T manufacturing.
- Develop and implement validation strategies, author key validation documents, and support regulatory submissions.
- Serve as a validation SME for audits, process improvements, and investigations.
- Collaborate with internal and external stakeholders to align validation strategies globally.
Requirements
- Master's degree in Engineering, Science, or related field.
- 10+ years of experience in biologics tech transfer and process validation, ideally in cell/gene therapy.
- Strong leadership experience.
- Deep knowledge of GMP, biotherapeutics process validation, and regulatory requirements.
- Fluency in English; Dutch or French is a plus.
What We Offer
- Opportunity to lead a team and drive best practices in CAR-T manufacturing.
- Chance to develop and implement validation strategies that ensure compliance with regulatory requirements.
- Collaborative environment with internal and external stakeholders.