MSAT Investigation Associate

Our client, a leading biotechnology company specializing in advanced therapies, is seeking a professional to lead manufacturing investigations. The role focus on driving root cause analysis and ensuring process robustness within a cell and gene therapy environment.

• Lead complex manufacturing investigations and establish strategies for root cause analysis to support critical product release windows.
• Oversee the implementation of CAPAs and process improvements in collaboration with technical process experts and engineers.
• Act as the primary support for regulatory authority inspections regarding manufacturing science and technology subjects.
• Draft and review technical documentation including impact assessments, change controls, and qualification protocols.
• Provide technical expertise to troubleshoot scientific and manufacturing issues on the shopfloor.
• Perform data trending and analysis to identify opportunities for continuous process improvement and robustness.

• You have 8+ years of relevant experience in process engineering or manufacturing science within a GMP environment.
• You bring expertise in leading manufacturing investigations including root cause analysis and CAPA implementation.
• You possess in-depth knowledge of cell and gene therapy processes and process technologies.
• You have experience with regulatory compliance and defending investigation strategies during inspections.
• You're a strong communicator capable of coordinating with cross-functional stakeholders in a matrixed environment.
• You are fluent in English.

Nice to Haves

• Knowledge of Dutch.
• Willingness to work in shifts and on weekends.