Sr. Director, Supply Chain
BioSpace · San Diego, CA · 1 mo ago
Management$244k–$298k/yrFull-time
Duties and Responsibilities
- Develop and execute the supply chain strategy aligned with clinical and commercial launch timelines for autologous iPSC-derived cell therapies.
- Lead scale-up from clinical to commercial manufacturing and distribution, ensuring supply continuity and patient safety.
- Design and govern supply chain network models, including sourcing, logistics, cold chain, and treatment center enablement.
- Set sourcing strategy and oversee supplier and vendor performance for critical materials, services, logistics, and technology platforms.
- Establish strategic partnerships with CMOs, logistics providers, and technology vendors to support global operations.
- Ensure business continuity through redundancy, risk mitigation, and supplier governance frameworks.
- Partner with Technical Operations to ensure manufacturing readiness, capacity scalability, and seamless technology transfers.
- Lead network design for commercial launch, including sourcing models, logistics pathways, cold-chain strategy, and treatment center support.
- Drive make-versus-buy decisions and long-term capacity and sourcing strategies.
- Ensure full compliance with cGMP, GCP, GDP, and global regulatory requirements across all supply chain activities.
- Partner with Quality and Regulatory Affairs to support inspections, audits, and submissions related to supply chain activities.
- Own supply chain risk management, deviation response, and change control impacting product availability or compliance.
- Lead supply chain readiness for product launch, including inventory strategy, shelf-life management, and demand alignment.
- Collaborate with Commercial and Medical teams to align supply capabilities with market access, patient demand, and treatment center needs.
- Ensure end-to-end chain of identity and chain of custody for autologous therapies.
- Champion implementation and optimization of digital supply chain systems (e.g., ERP, MES, orchestration platforms).
- Define enterprise KPIs, dashboards, and operating rhythms to drive visibility, accountability, and continuous improvement.
- Lead operational excellence initiatives focused on cost optimization, cycle-time reduction, and risk reduction.
- Build, lead, and scale a high-performing supply chain organization aligned with company growth.
- Develop leadership capability within the team and foster a culture of accountability, collaboration, and continuous learning.
Education and Experience
- Bachelor’s degree in Supply Chain, Engineering, Operations, Life Sciences, or a related field; advanced degree preferred.
- Minimum of 10 years of progressively responsible supply chain experience in biotechnology, pharmaceuticals, or advanced therapies, including experience supporting clinical-to-commercial transitions.
- Demonstrated experience leading complex, regulated supply chains with global scope and external partners.
- Proven people leadership experience, including building and scaling teams through organizational growth.
- Experience partnering with Manufacturing, Quality, Regulatory, Clinical, IT, Finance, and Commercial organizations at a senior level.