Manufacturing Sciences and Technology (MSAT) Process Engineer

Orcabiosystems
Princeton, US
On-site

Who this role is best for

Best suited to mid-level process engineers with biotechnology experience who thrive in manufacturing operations supporting clinical pipelines.

Best fit for

  • Professionals experienced in process monitoring and troubleshooting.
    — “process monitoring and troubleshooting
  • Candidates adept at implementing and validating process improvements.
    — “implementation and validation of process improvements

Things to consider

  • Role requires support for investigations and corrective actions.
    — “supporting investigations and corrective/preventive actions
  • Position is tied to a new East Coast manufacturing site.
    — “establishing manufacturing operations on the East Coast

How to stand out

  • Showcase experience with high-precision cell therapy products.
    — “high-precision cell therapy products
  • Demonstrate problem-solving in clinical product life cycle management.
    — “life cycle management of clinical and commercial products
Pace · SteadyCollaboration · MediumAutonomy · MediumDecision Impact · TeamLevel · Mid

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

  • improving efficiency and safety of drug product manufacturing
  • implementing process improvements
  • supporting investigations
Typical background
experience in manufacturing sciences and technology

Skills & requirements

Required

Manufacturing SciencesProcess EngineeringProcess MonitoringTroubleshootingValidationInvestigations

Preferred

Cell TherapyClinical Pipeline

Stack & domain

Manufacturing OperationsDrug Product Manufacturing ProcessProcess Monitoring And TroubleshootingImplementation And Validation Of Process Improvements And ChangesSupporting Investigations And Corrective/preventive ActionsHealthcare

About the role

Original posting from Orcabiosystems via Lever

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

Source: Orcabiosystems careers (Lever)

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