Associate Director, Biologics Stability

Summary: 
The Associate Director, Biologics Stability is a key position in our growing Technical Operations team that is engaged in clinical development of several exciting biologics candidates for inflammation & immunology indications. This individual will be responsible for overseeing key deliverables in biologics stability and reference standard management, will report directly to the head of Analytical Development & Quality Control function, and will join the analytical leadership. 
Primary responsibilities include creating high quality stability protocols, GMP raw data review, shelf-life management in quality system, GMP and non-GMP stability pull tracking and shelf-life projections for clinical supplies, reference standard creation and annual requalification in alignment with regulatory expectations and industry best practices, and related analytical operations.

Key Responsibilities:

• Provides technical leadership for DS and DP stability programs for Spyre clinical development assets.
• Establishes and prioritizes near term and longer-term objectives for stability, reference standard, critical reagents and related activities, aligned with overall business strategy.
• Ensures compliance of stability studies with FDA, cGMPs, ICH guidelines, and use of appropriate stability-indicating assays, and reference standards. 
• Follow industry best practices for long-term, accelerated and stress stability studies, 
• Contributes to the oversight of stability operations performed at CDMO laboratories that include GMP, non-GMP and pilot stability studies.
• Reviews stability protocols, reference standard protocols, summary reports, and raw data from CDMO and performs data verification. 
• Contributes to management of critical materials and assay reagents, and MCB/WCB stability.
• Build partnership with Quality Assurance in developing and managing GMP quality systems and compliance infrastructure for stability programs.
• Regularly reviews and makes impact assessments for required changes in stability studies and timely communicates potential impact on other team members or projects. Demonstrates strong judgment in ensuring that stability-related decisions are aligned with broader business goals of technical development functions responsible for DS and DP process/analytical.
• Regularly performs stability trending analyses and communicates cross-functionally to process, analytical, regulatory and quality.
• Explores efficiency in stability operations including streamlining and platforming stability protocols, data collection and trending.
• Other duties as assigned.

Ideal Candidate:

• Advanced degree in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, or related field.
• Experience in a biotechnology or pharmaceutical company, with 8+ years of direct involvement in biologics analytical development, protein stability, biologics method qualification, and characterization of protein degradation. 
• Direct experience of 3+ years in biologics GMP and non-GMP stability studies. Demonstrates expertise in biologics stability including GMP and non-GMP stability study planning, technical & regulatory requirements, stability data trending and product shelf-life strategy.
• Draws on deep expertise in stability, analytical assays and protein post-translational modifications (PTM) to take calculated risks, and to make decisions in new or unique situations especially for anomalous stability trending. 
• Builds collaborations with internal and external functions as needed for the portfolio projects. Interacts with senior management/executive team on specific topics when needed.
• Knowledge of structure-function correlation, biophysical characterization, critical quality attribute assessments, and potency assays (Binding ELISA, cell-based assay) is desirable.
• Experience in device testing (injection time, delivered volume, etc.) is a plus. 
• Excellent communication skills and the ability to work effectively in a fast-paced environment
• Experience in a small company or start-up environment is a plus.

What We Offer

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each year.
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $175,000 to $192,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.