Supervisor, Clinical Manufacturing, 2nd Shift
SacramentoOn-siteFull-time
AI Summary
supervises a cell therapy production team on 2nd shift, ensuring cGMP compliance, staffing, training, and real-time manufacturing execution.
About this role
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
This is a 2nd shift-based position, working on-site Monday through Friday, from 3 pm to 11:30 pm. The Supervisor, Clinical Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to associates, cell therapy production, oncology to ensure timely and compliant manufacturing.
Physical Demands
Work Conditions
Essential Duties & Key Responsibilities
Minimum Qualifications
Preferred Qualifications
Personal Qualities & Physical Demands
Skills
Aseptic ManufacturingBatch RecordsBiosafety CabinetsCAPACGMPChange ControlClean Room OperationsDeviation InvestigationsPPEQAQCSOPs
Explore related jobs
More jobs at Orca Bio
Manager/Director, Procurement and Materials (Contract Role)Sacramento, CA
Research Associate, Analytical Development-CONTRACTSacramento, CA
Specialist, Production Project SupportSacramento, CA
Specialist, IT & Manufacturing Systems Support (Off-Shift)Sacramento, CA
Manager, Quality ControlSacramento, CA
Director, Analytical Development (Flow Cytometry & Method Validation)Sacramento, CA