The Associate Director of MSAT - Analytical Sciences is a senior scientific leader supporting the tech transfer and commercial manufacturing of biologics.
They oversee analytical lifecycle management, method validation, comparability, and investigations, ensuring robust support for biologic products such as mAbs and fusion proteins.
Responsibilities include leading analytical strategies, supporting technology transfers, troubleshooting, authoring regulatory submissions, and managing external CMO/CRO relationships.
Qualifications require a PhD or MS with 8+ or 12+ years of experience in biologics analytics, expertise in analytical techniques, and knowledge of regulatory guidelines.
Key competencies include strategic thinking, leadership, communication, collaboration, and a patient-centric approach.
The role offers a competitive salary, comprehensive benefits, and emphasizes compliance, data integrity, and external partnership management.