- Execute and provide oversight for the tracking of domestic and international shipments of internally manufactured radiopharmaceutical drug product programs.
- Execute the scheduling of domestic and international supply and shipment of RayzeBio drug products and other clinical trial materials manufactured by third party contract manufacturers.
- Act as the primary contact for customs authorities.
- Execute the shipment tracking and delivery confirmation program.
- Execute the interaction and triage of import and export shipments including the documentation associated with customs clearing activities.
- Provide support with the development and execution of packaging design and shipping validation.
- Provide tactile, hands-on support for logistics operations.
- Operate under the guidance 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 and the Order Management system.
- Support the efforts to commercialize the distribution of current clinical programs upon FDA approval.
- Execute the day-to-day logistics operations focused on KPIs to ensure compliance and operational control related to shipment delivery, on-time and in full
- Support the training of future Supply Chain team members.
- Ensure personal compliance with DOT, EH&S, Radiation Safety and GMP requirements as required.
- 3+ 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 / Order Management 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
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Logistics Specialist - Indianapolis, United States - RayzeBio
Description
Position: Logistics Specialist
Location: Indianapolis
Background
RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC) and breast cancer. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
Job Description (22NH)
Located in our Indianapolis, IN facility, the Logistics Specialist will be responsible for providing logistics support related to domestic and international shipping and distribution of clinical trial and commercial products for RayzeBio programs. In this role, the Logistics Specialist shall lead support the execution of all clinical trial and future commercial shipping and distribution activities for products manufactured internally at RayzeBio and externally through third parties. Responsibilities also include supporting the creation and implementation of the Supply Chain department procedures related to logistics. Additionally, Logistics Specialists will become one of the subject matter experts (SME) supporting compliance GXP and DOT regulations as required.
Job Responsibilities
Education and Experience:
Skills and Qualifications:
