We are seeking a Manager / Associate Director / Director / or Sr Director* of Supply Chain to lead and direct all supply chain management activities for our development candidates and related investigational products, including but not limited to, planning, master scheduling, inventory management, supply, sourcing, logistics, warehousing, and distribution. This may be a part or full time position.
*Title will be commensurate with experience.
- Assures fulfillment of all supply milestones across all Alpine development programs, including all clinical trials. Activities include demand forecasting, trial monitoring, resupply planning, label design, packaging, and IRT set-up and distribution. Scope will include primary investigational drug, comparator drugs, non-investigational products, and ancillary supplies as applicable.
- Identifies and manages all contract vendors related to clinical supply chain, including packaging, labeling, kitting, and distribution
- Predicts and mitigates program risks, including deep root analysis, in coordination with overall CMC, clinical, and regulatory strategies
- Supports and may manage overall budget review and approval
- BS in pharmaceutics, chemistry, biology, material science, engineering, or related disciplines with 5+ years of hands on clinical supply chain experience in the pharmaceutical industry. Certifications such as CSCP, CPIM, CPM, CPP desirable.
- Experience and expertise with global clinical supply chain, including US, Europe, Asia, and Oceana.
- Demonstrated experience managing CMOs and CROs. Cold chain distribution experience highly desired.
- Excellent project management and ability to navigate in a fast-paced but resource-constrained environment
- Experience with supply chain software, inventory control systems, and pharmaceutical quality systems
- Familiarity with global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP).