Sr Director, Analytical Operations
About this role
Job Description
The Senior Director in Pivotal and Commercial Biologics Analytical Development will be responsible for leading analytical development activities spanning structural characterization of protein-based modalities, establishing robust and comprehensive pivotal and commercial stage comparability strategies, establishing product-specific critical quality attributes (CQAs), and devising analytical testing strategies for characterization and control of glycosylation variants and excipient-related attributes. They will be responsible for a group of approximately 20 scientists by providing guidance, prioritization, and career development leadership. Through these activities they will play an instrumental role in ensuring the establishment of robust control strategies to support regulatory filing strategies.
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