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Biologics Stability Associate Director - Fort Collins Colorado

Company: VirtualVocations
Location: Fort Collins, Colorado
Posted On: 02/06/2025

A company is looking for an Associate Director, Biologics Stability.



Key Responsibilities:

Provides technical leadership for stability programs and establishes objectives aligned with business strategy
Ensures compliance of stability studies with FDA, cGMPs, ICH guidelines, and oversees stability operations at CDMO laboratories
Regularly performs stability trending analyses and communicates findings cross-functionally


Required Qualifications:

Advanced degree in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, or related field
8+ years of experience in biologics analytical development and stability studies
3+ years of direct experience in biologics GMP and non-GMP stability studies
Expertise in stability, analytical assays, and protein post-translational modifications
Experience in a small company or start-up environment is a plus More...

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