Senior Validation Manager
4 weeks ago
At S3 Science, we are seeking a highly skilled Senior Validation Manager to lead the development, validation, and lifecycle management of critical test methods for groundbreaking gene therapy products.
Key Responsibilities:
* Spearhead the development and validation of novel and established analytical methods for gene therapy products, driving innovation in therapeutic approaches
* Oversee the complete lifecycle management of assays, equipment, materials, and in-process samples, ensuring optimal performance and compliance throughout
* Be responsible for the implementation of test methods within defined timelines, enabling the seamless launch of new gene therapies
* Ensure all methods are compliant with EU and FDA GMP regulations, maintaining data integrity and supporting regulatory submissions
Requirements:
* Proven experience in analytical method development and validation
* Strong knowledge of EU and FDA GMP regulations
* Excellent project management and leadership skills
* Ability to communicate effectively with stakeholders across departments
About S3 Science:
S3 Science is a leading biotechnology company dedicated to developing innovative gene therapy products. We are committed to excellence in research, development, and manufacturing, and we are seeking talented individuals to join our team.
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