Specialist or Senior Specialist, Apheresis Operations Support - Ohio Valley

Req #: 1902014
Location: Seattle, Washington, United States
Job Category: Technical Development
Work Location: 400 Dexter Ave N. 98109
Organization: Supply Chain
Employee Status: Full-time
Job Type: Regular
Other Locations: United States-Indiana-Indianapolis, United States-Ohio-Cleveland, United States-Ohio-Columbus

Patient Operations specializes in the supply chain functions that are unique to managing cellular therapy products. Our focus is on delivering timely, accurate and customer focused service to our customers. Our Patient Operations department has an opportunity for a Support Specialist to join the team supporting operations functions for the Ohio Valley region. Ideally, this position will be based in Seattle, however highly qualified remote candidates will be considered.

Job Summary:

The primary focus of the Apheresis Support Specialist role is to assist with the qualification, training, and management of the cell collection network. The Specialist will also be involved in site evaluations and on-going assessments of collection centers and Juno requirements. This is a critical role within the Patient Experience organization that requires someone with demonstrated experience working in a regulated environment, exceptional communication and organizations skills, as well as the flexibility to travel up to 50%.

Job Description:

• Work with internal and external business partners to ensure cell collection centers successfully complete all qualification activities and are prepared to perform collections for Juno within the required timelines.
• Track qualification activities for assigned sites and communicate timeline delays to team.
• Work with manager to develop and execute mitigation plans for delayed timelines.
• Provide Quality Systems support by participating in deviation/change management activities and impact/investigation assessments for cell collection centers.
• Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
• Represent the department on cross-functional project teams, as requested.
• Comply with applicable SOP's and FDA regulations.

Minimum Qualifications for Specialist, Apheresis Operations Support:

• Bachelor's degree; ideally in Life Sciences
• 3+ years of experience working in a regulated environment (e.g. GMP, GCP, GTP, Joint Commission, FACT, AABB)
• Ability to enjoy a high paced environment, meet deadlines, and prioritize work from multiple projects
• Ability to build effective relationships across company teams, and with external partners
• Strong teamwork skills and excellent customer service skills
• Accurate, responsive, and thorough communicator (both oral and written)

Minimum Qualifications for Senior Specialist, Apheresis Operations Support:

• Bachelor's degree; ideally in Life Sciences
• 6+ years of experience working in a regulated environment (e.g. GMP, GCP, GTP, Joint Commission, FACT, AABB)
• Ability to enjoy a high paced environment, meet deadlines, and prioritize work from multiple projects
• Ability to build effective relationships across company teams, and with external partners
• Strong teamwork skills and excellent customer service skills
• Accurate, responsive, and thorough communicator (both oral and written)

Preferred Qualifications:

• Knowledge of Apheresis and Good Tissue Practices
• Experience working in Cellular Therapy or Stem Cell Transplant programs
• Experience working with critical raw material suppliers or contract manufacturing organizations
• Experience in project coordination or management
• Experience with adult learning principles

About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.