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Orca Bio

Posted 6 months ago

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Associate, Cell Therapy Production, 3rd Shift

SacramentoOn-site

AI Summary

Operates and monitors manufacturing equipment to produce cell therapy products in a GMP cleanroom environment, following SOPs and batch records while maintaining quality standards and aseptic techniques.

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 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.

Physical 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.

    • Work Conditions

  • Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
  • Must be comfortable regularly participating in video-based meetings.
  • May be required to work scheduled overtime, weekends, or holidays based on business needs.

    • Essential Duties & 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
  • Required to participate in an on-call rotation as needed for weekend and/or holiday shifts

    • Minimum Qualifications

  • 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

    • Preferred Qualifications

  • 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

    • 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
  • A sense of humor is always appreciated

    • Skills

    Aseptic TechniquesBatch RecordsCell AnalysisCell CharacterizationCell CultureCell SortingCGMPCleanroom GowningGMPGrade B/C CleanroomPPEQuality SystemsSOPsValidation

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