Location: Indianapolis
Summary
The Manager of Supply Chain Operations will be responsible for supporting the supply chain processes related to manufacturing and distribution of clinical trial and commercial products for RayzeBio programs. Responsibilities also include supporting the creation and implementation of the Supply Chain department procedures: logistics, warehousing, and materials management. Additionally, the Manager of Supply Chain Operations will become a subject matter expert (SME) in supply chain systems as well as supporting compliance with GXP and DOT regulations as required.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
- Subject matter expert for the RayzeBio procurement process and inventory management systems.
- Provide support to the Business process owner for material specification process.
- Supply chain lead for Supplier Quality Management program.
- 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 strategic procurement support with the primary focus on material readiness for batch manufacturing.
- Assist with the establishment of policies and standard operating procedures to ensure compliance with GXP regulations as required.
- Manage the purchase requisition to purchase order process.
- Support the efforts to commercialize the distribution of current clinical programs upon FDA approval.
- Provide strategic oversight over the day-to-day supply chain operations focused on KPIs to ensure compliance and operational control related to procurement, warehousing, and logistics.
- Provide managerial oversight to other members of the Supply Chain team directly involved in planning and material management.
- Support the training of future Supply Chain team members.
Education and Experience
- 5+ years of proven experience in a cGMP manufacturing facility.
- Demonstrated working knowledge of supplier management and procurement operations.
- Demonstrated working knowledge of working in a cGMP warehouse environment preferred.
- ERP / EIS implementation and tactile execution in a cGMP facility.
- Demonstrated experience in dealing with regulatory agencies.
Skills and Qualification
- Possess the ability to multitask in several supply chain related disciplines.
- Demonstrated knowledge in cGMP processes.
- 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.
Physical Demands
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.
Work Environment
The noise level in the work environment is usually moderate.
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