MSAT Investigation Associate
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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.
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