RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
The Manager,Supply Chain Operations will be responsible for supporting domestic and international shipping and distribution of clinical trial and commercial products for RayzeBio programs. In this role, the Manager,Supply Chain Operations shall assist with the management of all clinical trial and commercial shipping and distribution activities for products manufactured internally or externally through third parties. Responsibilities also include supporting the creation and implementation of the Supply Chain department procedures: logistics, warehousing, and materials management. Additionally, the Manager,Supply Chain Operations will become a subject matter expert (SME) supporting compliance GXP and DOT regulations as required.
- Execute and provide oversight for the tracking of domestic and international shipments of internally manufactured radiopharmaceutical drug product programs.
- Manage the scheduling of domestic and international supply and shipment of RayzeBio drug products and other clinical trial materials manufactured by third party contract manufacturers.
- Execute the receipt of incoming radioactive materials and support the seamless customs clearance and approval from domestic and international suppliers.
- Assist with the supply and demand forecasts, labeling and packaging plans for finished goods and/or investigational medicinal product and implement scenarios and reporting for study execution teams.
- Provide tactile, hands-on support of operational departments responsible for supply chain and logistics, warehousing, and materials management.
- Assist with the establishment of policies and standard operating procedures to ensure compliance with DOT and GXP regulations as required.
- Support the implementation of the Electronic Inventory System / ERP.
- Manage the purchase requisition to purchase order processing, including the creation and management of Material Specifications.
- Support the efforts to commercialize the distribution of current clinical programs upon FDA approval.
- Execute the day-to-day supply chain operations focused on KPIs to ensure compliance and operational control related to logistic and warehousing.
- Support the training of future Supply Chain team members.
- Ensure Warehouse personnel comply with DOT, EH&S, Radiation Safety and GMP requirements as required.
Education and Experience:
- 5+ years of proven supply chain logistics experience (2+ in a cGMP facility preferred).
- Domestic and international shipping experience, including knowledge of customs clearance and regulatory requirements for RAM shipments for ex-US countries.
- Radiopharmaceutical and DOT compliant shipping experience preferred.
- Demonstrated working knowledge of working in a cGMP warehouse environment preferred.
- ERP / EIS implementation and tactile execution in a cGMP facility.
- Strong understanding of domestic and international shipping (Radiopharmaceutical experience preferred).
- Demonstrated knowledge in DOT, GMP, and NRC regulations
- Excellent professional ethics, integrity, and ability to maintain confidential information
- Highly motivated and organized professional with the ability to work under pressure while meeting corporate goals and objectives
- Medical, Dental and Vision plans
- Life, Accidental Death, Personal Loss, and Disability
- Flexible Spending Account (FSA)
- 401(k) Retirement Plan
- Equity/stock options
- Paid Time Off
- Company paid holidays
To apply, please send CV to firstname.lastname@example.org