Senior Specialist, Clinical Supply Chain

POSITION SUMMARY

Umoja Biopharma is seeking a Senior Clinical Supply Chain Specialist to join our fast-paced Supply Chain department located at our CLIMB cell/gene therapy manufacturing facility in Louisville, Colorado. This position will primarily support Clinical Supply Chain activities, including but not limited to working with Third Party Logistics providers to ensure on time and compliant supply of clinical material to clinical sites. This position will require a high level of accuracy, compliance, and planning.

This position may also assist in additional activities in support of Supply Chain at the Colorado Laboratory and Innovative Manufacturing Building (The CLIMB), including but not limited to shipping/logistics and Material Requirements Planning (MRP) support.

This role represents Umoja internally at multiple levels of the organization as well as externally with Third Party Logistic Providers. The Senior Clinical Supply Chain Specialist will work closely with Supply Chain, Clinical Operations, Quality, External Quality, Vendors, Finance, and the Warehouse teams. We are looking for a self-starter who brings their excellent communication skills, attention to detail, and ability to flex and pivot in an ever-changing start-up environment.

The successful candidate will have experience in managing Clinical Supply Chain activities, business workflow process and continuous improvement, clear communication with strong personnel skills to collaborate with and influence internal stakeholders, as well as proven ability to operate independently with limited direction on initiatives aligned with Umoja goals.

CORE ACCOUNTABILITIES

Specific responsibilities include:

• Clinical Supply Planning – develop supply plans and strategies to ensure on-time supply to clinical sites based on clinical forecasts, identify, mitigate, and resolve supply chain risks, issues, and recall support
• Logistics and Distribution – work with third party logistic provider to manage domestic and global distribution
• Third Party Logistic Provider (3PL) management – oversee label, pack, and distribution activities at 3PL, responsible for contract management, including contract approval, budget, and invoicing
• Compliance – ensure adherence to GMP regulations as required, generate and maintain applicable SOPs and shipment tracking
• Cross-functional collaboration – work closely with Clinical Operations, External Quality, Regulatory, and Finance as required
• Be a champion for policy, process, and compliance for all GMP-related procurement and clinical supply chain activities.
• Assist the Supply Chain Team with additional responsibilities in support of shipping/logistics and/or material resource planning as needed

The successful candidate will have:

• Bachelor's degree in science, engineering, business or a related discipline and a minimum of 8 years of relevant industry experience in business operations role, or an equivalent combination.
• Minimum of 5 years of clinical supply chain/supply chain, logistics, and/or operations-related experience in a cGMP environment.
• Working knowledge of Clinical Supply Chain activities and strategies.
• Experience working in a regulated manufacturing environment; pharmaceutical or biotechnology
• Detail oriented with the ability to identify and solve complex problems with minimum assistance.
• Self-motivated, pro-active, and able to work well both on a team and independently.
• Strong communication skills are a must.

Preferred Qualifications:

• Ability to multi-task in a fast-paced, matrix environment
• Experience with IRT systems for clinical supply management
• Experience with ERP systems, specifically NetSuite is highly desirable
• Working knowledge of ordering procedures, production planning, inventory replenishment methods, MRP, and ERP systems
• Strong Microsoft Office skills, working knowledge of Smartsheet

Physical Qualifications:

• Ability to wear personal protective equipment including gloves, protective clothing, and eye safety glasses.
• Ability to perform physical tasks including standing, use of hands, walking, bending, kneeling, and occasionally moving materials up to 30 pounds.
• Ability to work off hours, on-call, and/or weekends on occasion or in emergency situations.
• Ability to work onsite with flexibility to work from home as required.

Salary Range: $106,600 - $131,700