Barber Career Map
Barber Career MapFind jobs where you want to live.
active · Approximate location

Associate, Cell Therapy Production, 3rd Shift

Orca Bio·Sacramento, CA
full timeSacramento, CA

Create a free profile to personalize salary, commute and role fit.

AT A GLANCE

Manufacturing2+ years experienceFull TimeRegular, Full-Time Employee

Required

  • 2+ years experience
Preferred qualifications are helpful, not automatic disqualifiers.
Apply on Company Site

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

About the 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 commercial-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 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 3rd shift-based position, working on-site Monday through Thursday, from 9pm to 7:30am. Reporting into the assigned supervisor, clinical manufacturing, the Associate, Cell Therapy Production plays a critical role in the production of Orca's cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.

Responsibilities

  • Operate and closely monitor advanced manufacturing equipment to support the production of cutting-edge cell therapy products
  • Follow and execute standard operating procedures (SOPs) and batch records to perform production activities
  • Identify and resolve equipment or process issues, escalating to management as necessary
  • Complete all assigned training to maintain required technical proficiency and adhere to cGMP standards
  • Operate, monitor, clean, and prepare advanced automated equipment for cell processing, expansion, and filling in Grade B/C cleanroom environments. All required PPE and GMP-compliant gowning are provided by the company
  • Contribute to continuous improvement efforts, including manufacturing efficiency, compliance practices, and support for investigations, deviations, and change control processes
  • Required to participate in an on-call rotation as needed for weekend and/or holiday shifts

Requirements

  • B.S. degree required in biology or related field
  • 1-2 years of experience in process sciences, discovery research of manufacturing
  • Experience with aseptic techniques
  • M.S. degree in biology or related field
  • Prior experience in GMP and lab-scale manufacturing, including validation and quality systems
  • Familiarity with cell/gene therapy, including working with human cells, cell characterization methods, sorting and analyzing cells
  • Aseptic techniques
PostedNot listed
Statusactive
CommuteDistance only

Other Jobs From This Employer

Senior Manager / Associate Director, Gross-to-Net & Revenue PlanningMenlo Park, CA
Salary not listed
Associate, Packaging Operations and Cold Chain Handling - Day ShiftSacramento, CA
Salary not listed
Clinical Research AssociateRemote
Salary not listed
Cell Therapy Production Associate, Oncology - Night Shift (Multiple Positions)Sacramento, CA
Salary not listed
Senior Director, Regulatory AffairsMenlo Park, CA
Salary not listed