Associate Director, Biologics Stability - Remote

Overview

Spyre Therapeutics is a biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23.

In Short

• The Associate Director, Biologics Stability is a key position in our growing Technical Operations team.
• Responsible for overseeing key deliverables in biologics stability and reference standard management.
• Reports directly to the head of Analytical Development & Quality Control function.
• Creates high quality stability protocols and manages shelf-life projections.
• Ensures compliance of stability studies with FDA, cGMPs, and ICH guidelines.
• Contributes to the oversight of stability operations performed at CDMO laboratories.
• Builds partnerships with Quality Assurance for GMP quality systems.
• Regularly performs stability trending analyses and communicates cross-functionally.
• Explores efficiency in stability operations.
• Other duties as assigned.

Requirements

• Advanced degree in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, or related field.
• 8+ years of experience in biologics analytical development.
• 3+ years in biologics GMP and non-GMP stability studies.
• Expertise in stability, analytical assays, and protein post-translational modifications.
• Excellent communication skills and ability to work in a fast-paced environment.
• Experience in a small company or start-up environment is a plus.

Benefits

• Opportunity to work in a fast-paced, dynamic environment.
• Market competitive compensation and benefits package.
• Unlimited PTO.
• Two, one-week company-wide shutdowns each year.
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings.