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Posted 4 months ago

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Cell Therapy Production Associate, Oncology - Day Shift

SacramentoOn-site

AI Summary

Production Associate responsible for manufacturing life-saving cell therapy products, executing SOPs, operating equipment, maintaining aseptic conditions, and documenting activities in a regulated GMP environment.

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.

The Cell Therapy Production Associate, Oncology - Day Shift plays a critical role in the production of Orca Bio’s life-saving cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. Reporting into the assigned supervisor, commercial manufacturing, the job 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.
Day Shift Hours worked:
• 6am to 6:30pm or
• 6:30am to 7:00pm
Work Week Schedule:
• Sunday, Monday, Tuesday + every other Wednesday or
• Thursday, Friday, Saturday + every other Wednesday

Physical and Work Demands

  • Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
  • Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
  • Must be comfortable regularly participating in video-based meetings.
  • Schedules, as noted, include daily overtime, Saturday or Sunday work and holidays.

    • Key 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

    • Minimum Qualifications

  • Associate degree and at least 1 year of experience in biomanufacturing, OR
  • High School Diploma/GED with a minimum of 2 years of biomanufacturing experience

    • Preferred Qualifications

  • Experience working in GMP-compliant environments
  • Involvement in investigations, deviations, and change control processes
  • B.S. degree in Biological or related sciences

    • Personal Qualities

  • Highly detail oriented with special attention to quality and documentation
  • Strong work ethic, curiosity to learn and contribute in a fast-paced, collaborative environment
  • Excellent interpersonal skills and ability to communicate effectively
  • Ability to work both independently and in a collaborative manner
  • Highly tolerant and respectful of all team members

    • Skills

    Aseptic TechniqueBatch RecordBiomanufacturingCell TherapyCGMPCleanroom GowningContinuous ImprovementEquipment OperationGMPS&OP

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