Available Positions
There are currently 3 open positions.
We are currently seeking talented and driven individuals to join our growing team.
We have three open positions available. Please see the listings below for detailed descriptions and application instructions.
Quality Assurance Coordinator
The Quality Assurance Coordinator performs monitoring, auditing, and overseeing the quality of clinical laboratory testing used to match organ donations with viable recipients. In addition, this position is responsible for the quality oversight of the stem cell processing services, transport, and cryopreservation of the product from the apheresis center, quality oversight of the performance of bedside thaw and infusion assistance in the hospital infusion center, and quality oversight of post-transplant surveillance of indicators of cell therapy product purity and potency.
Key Responsibilities:
- Participates in regulatory submissions for Biological License Applications (BLA), filings, and communications with regulatory and accreditation agencies including audits including but not limited to the FDA, AABB, CAP, ASHI, FACT, and AATB and leads internal audits to ensure compliance.
- Oversees quality assurance in compliance with strict regulatory standards to make sure ClinImmune is delivering pure, and potent products for patient treatment and following proper laboratory protocols for patient sample testing and resulting. This requires laboratory oversight, and meeting regulatory agency requirements to ensure no harm can come to a patient.
- Reviews and assists with the preparation of occurrence (deviation) reports, complaints, and corrective and preventative actions (CAPA).
- Recognizes and reports trends and opportunities for improvement (OFI) through audits and occurrence reports to the Director of Regulatory Affairs and/or Quality Manager, which are then shared with ClinImmune management and staff.
- And more…
Information Technology Principal Professional
The Information Technology Principal Professional offers the ability to work alongside and support highly skilled scientists and clinicians in the areas of clinical laboratory testing to facilitate successful organ transplants, and clinical and research related cell and gene therapies. Work includes lab information systems software and database support, creation and management of contingency systems to ensure no lapse in patient care.
Creativity and research into IT solutions to optimize workflows, troubleshooting, and mentorship of up-and-coming IT staff in a fast paced, mentally engaging and supportive work environment is what can be expected in this role.
Key Responsibilities:
- Administration, maintenance, and validations of Microsoft SQL Server and Access databases and automated reporting systems.
- Collaborate with SOM IT to set up, configure and maintain virtual server performance, security, and uptime.
- Oversee and maintain ClinImmune’s backup processes to ensure data integrity and disaster recovery readiness, utilizing virtualization and containerization technologies.
- Install, configure, and maintain computer hardware and software for individual and shared lab systems including end-user support and troubleshooting.
- Stay current with emerging technologies relevant to lab and IT operations including coordinating with software vendors and internal teams to design and implement advanced solutions for the ClinImmune HLA LIMS, SCPM (stem cell database), and future systems.
- Serve as primary IT contact between ClinImmune and client hospitals, CAP, ASHI, FDA and other regulatory agency inspectors.
- Supervise, train, and mentor ClinImmune IT Team.
Cellular Therapy Laboratory Aide/Search Office Assistant
ClinImmune is currently seeking a Cellular Therapy Laboratory Aide/Search Office Assistant with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty, and staff of diverse backgrounds. This is a laboratory support position that will assist cell therapy lab technicians and search coordinators with day-to-day functions of clinical lab operations and search office processes.
Key Responsibilities:
- Preparing incoming lab supplies for quality release.
- Monthly inventory check of laboratory supplies and reagents.
- Maintaining lab equipment including function verifications.
- Receiving of cellular therapy products, including identity and integrity check.
- Assisting with preparations to ship cord blood units to transplant centers worldwide.
- Witnessing of stem cell products to verify identity and integrity.
- Assisting with pulling frozen reference samples from stem cell products for testing. Rearranging/reorganizing the contents of -80 freezers.
- Assisting with filling LN2 dry shippers containers in preparation for transport of stem cell products. Also, transports stem cell product samples to Flow lab for testing.
- Organizing stem cell products and patient folder filing cabinets. Purges and scans search office paperwork
- Cord blood shipment data entry using NMDP CordSource web database.