Transplant Operations Associate

Ossium Health•Indianapolis, IN

11d•Onsite

About The Position

Ossium’s mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good. We’re hiring a Transplant Operations Associate who will play an integral part in ensuring our life-saving bone marrow is distributed safely, accurately, and efficiently. The Associate will provide support and execution of tasks specifically related to distribution of human bone marrow (HPC, Marrow) for clinical use. The ideal candidate has a basic understanding of the theory, concepts, and regulations behind cGMP regulations. In this role, you will report to and work closely with our Director, Transplant Operations to prepare COAs (Certificates of Analysis), draft and maintain documentation, and be a part of the team that ensures delivery of our novel cryopreserved bone marrow product. This role involves following SOPs (Standard Operating Procedures) and following cGXPs (current Good Practices).

Requirements

BS or BA in Biological Sciences
2+ years experience working in a life sciences operations role
High level of attention to detail in both operations and documentation
Excellent written and oral communication skills
Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
This position is based full-time on site in our Indianapolis science facility

Nice To Haves

Experience in cell therapy, tissue banking, blood banking or a closely-related industry

Responsibilities

Prepare Certificates of Analysis for HPC, Marrow products
Complete Delegations of Eligibility for HPC, Marrow products
Assist in shipping of testing samples from bank
Maintain documentation and data related to distributed HPC, Marrow products obtained internally or externally
Perform activities in accordance with current Good Practices (cGXPs)
Update product and sample inventory using an electronic inventory system
Perform routine duties required to clean, maintain and operate distribution and storage equipment
Assist in drafting and revising of departmental procedures
Work with coworkers and supervisor to effectively troubleshoot distribution issues; assist with investigations into root cause analysis
Recognize and communicate work environment issues/observations to supervisory staff in a timely manner
Assist in maintaining distribution records in an inspection ready state at all times
Assist with the World Marrow Donor Association (WMDA) listings to make Ossium HPC, Marrow available worldwide
Work with internal teams to improve and automate HPC, Marrow distribution procedures
Interact with transplant center clinicians and cell therapy teams to ensure the successful delivery of products