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Senior Manager, Analytical Sciences at Summit Therapeutics, - ApplyBlast

Senior Manager, Analytical Sciences

Summit Therapeutics,

3 days ago

Princeton, New Jersey, United States

Onsite

Full Time

Senior

0 applicants

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About this role

The Senior Manager, Analytical Sciences provides scientific and technical leadership for analytical activities supporting biologic products from clinical development through post-approval support. This role involves advancing robust analytical strategies, overseeing method development, validation, and transfer, and contributing to product characterization, comparability assessments, and regulatory submissions. The position requires strong technical expertise, effective external partner management, and a flexible, hands-on approach in a dynamic development environment.

Responsibilities

Lead analytical method development, qualification, validation, and transfer activities for biologic drug substances and drug products
Design and oversee extended product characterization studies to establish a comprehensive understanding of product quality attributes
Author and critically review analytical sections of regulatory submissions and responses to health authority questions