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Orca Bio

Posted 3 months ago

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Engineer, Manufacturing Sciences & Technology (MSAT)

SacramentoOn-siteFull-time

AI Summary

The engineer analyzes and improves MSAT processes for commercial cell-therapy product manufacturing, handling process monitoring, troubleshooting, and validations across GMP facilities.

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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.

The Engineer, MSAT works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions.

Physical Demands

  • Production Associate Roles: 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.
  • Most roles 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

  • Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

    • Essential Duties & Key Responsibilities:

  • Performs ongoing monitoring of existing commercial products and processes
  • Generate metrics and reports for process monitoring and continuous process verification
  • Support process improvements and changes including electronic batch record creation and modifications
  • Performs Out of Trend Investigations based on trends from process monitoring
  • Provides troubleshooting support for manufacturing events, equipment performance and material issues
  • Performs root cause analysis to isolate cause of events and determine appropriate corrective actions
  • Authors and owns change controls, technical protocols, reports and activities to support process improvements
  • Writes and ensures proper execution of validation protocols and testing in line with required life cycle management activities
  • Leads design, project management and execution of MSAT projects, introduction of new materials, and equipment at multiple GMP facilities
  • Assess potential impact of supplier changes, material changes, Drug product labels, Drug Product packaging and cold chain transport changes and excursions

    • Minimum Qualifications:

  • B.S. in Engineering or similar fields
  • 3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
  • Prior experience in regulated, GMP manufacturing operations
  • Experience with data analysis and trending using JMP or other statistical software
  • Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition

    • Preferred Qualifications:

  • Experience in biotechnology and cell therapy manufacturing preferred
  • Experience with commercial packaging, labeling, and cold chain strongly preferred
  • Excellent communication and problem solving skills, with a desire to improve upon established processes

    • Skills

    BiologicsCAPAChange ControlCold ChainData TrendingDrug Substance ManufacturingElectronic Batch RecordsFill And FinishGMPJMP Or Similar Statistical SoftwareLabelingManufacturing EquipmentMSATOut-of-trend InvestigationsPackagingProcess MonitoringProcess ValidationQA DocumentationQMSRoot-cause AnalysisStatistical AnalysisTra..Validation Protocols

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