Spyre Therapeutics · 14 hours ago
Director, Drug Product & Supply Chain
United States
Full-time
Remote
Director/Executive
$215K/yr - $230K/yr
10+ years expSpyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease and rheumatic diseases. The Director, Drug Product Clinical Supply Chain is a senior leadership role responsible for the end-to-end strategy and execution of clinical drug product supply, ensuring compliance and quality throughout global clinical trials. This role involves leading supply chain activities, managing vendor relationships, and ensuring regulatory readiness for clinical programs.
BiotechnologyTherapeutics
Responsibilities
Own the global clinical drug product supply strategy for assigned programs, ensuring alignment with clinical development timelines, regulatory requirements, and corporate objectives
Lead end-to-end clinical supply planning and execution to ensure uninterrupted, on-time, and compliant delivery of drug product throughout global clinical trials
Provide strategic direction for scaling drug product supply capabilities from Phase 2 through Phase 3 and commercial readiness
Direct all clinical drug product supply chain activities, including demand forecasting, supply planning, IRT support, labeling strategy, packaging and labeling operations, release, distribution, inventory management, expiry strategy, and cold chain oversight
Establish and maintain robust processes, systems, and controls to ensure compliance with GMP, GDP, and global regulatory requirements
Perform short-, medium-, and long-term supply forecasting and oversee monthly forecasting and production planning cycles
Provide senior technical oversight of drug product formulation, manufacturing, packaging, and labeling activities conducted by external CMOs
Evaluate and implement new technologies, systems, and delivery approaches to improve supply robustness, efficiency, and scalability
Ensure technical and supply chain readiness for regulatory submissions and inspections
Lead CMO and vendor strategy, including selection, contracting, performance management, change control, and issue resolution across all outsourced drug product supply activities
Oversee procurement of comparator drug products and matching placebo, as required
Build strong, performance-driven partnerships with external vendors to support clinical and future commercial needs
Provide leadership oversight of quality-related activities impacting clinical drug product supply and participate in quality improvement initiatives
Serve as a senior subject matter expert in clinical supply GMP, GDP, and related business processes
Proactively identify risks, trends, and opportunities for continuous improvement across drug product technical operations and supply chain processes
Author, review, and approve clinical and technical documentation, including clinical labels, packaging batch records, protocols, pharmacy manuals, and regulatory submissions (IND, IMPD, NDA)
Own clinical drug product supply budgets for assigned programs, ensuring accurate cost forecasting and alignment with inventory and demand strategies
Act as a key cross-functional leader, providing clear communication, decision-making, and guidance to internal teams and senior management
Other duties as assigned
Qualification
Required
Bachelor's degree or advanced degree in a scientific, engineering, or related discipline
10+ years of experience in pharmaceutical or biotech drug product technical operations and clinical supply chain, with demonstrated leadership responsibility
Proven experience leading global clinical drug product supply for complex Phase II/III randomized, I&I and/or IBD clinical trials
Strong working knowledge of GMP, GDP, GCP, and global import/export regulations related to clinical drug product supply
Demonstrated success managing complex, outsourced drug product supply chains and CMO relationships
Strategic mindset with strong analytical, problem-solving, and decision-making capabilities
Excellent communication and leadership skills with the ability to influence cross-functional teams and senior stakeholders
Preferred
Experience in a small or emerging biotech environment preferred
Benefits
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
Commitment to provide professional development opportunities.
Remote working environment with frequent in-person meetings to address complex problems and build relationships.
Company
Spyre Therapeutics
Spyre Therapeutics is a biotechnology business that is developing a strong pipeline of antibody therapies.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$835M2025-10-13Post Ipo Equity· $275M
2024-11-18Post Ipo Equity· $200M
2024-03-18Post Ipo Equity· $180M
Leadership Team
Kate Chevlen
Chief Commercial Officer
Sheldon Sloan
Chief Medical Officer
Recent News
thefly.com
2026-01-03
2025-12-01
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