Manufacturing Process Lead

Orcabiosystems
Princeton, US
On-siteCareer-pivot friendly

Who this role is best for

Geared toward senior engineers comfortable with life cycle management of clinical and commercial products in biotechnology manufacturing.

Best fit for

  • Senior engineers with process improvement experience in biotech manufacturing.
    — “improve the efficiency and safety of the drug product manufacturing process
  • Candidates experienced in troubleshooting and validating process changes.
    — “implementation and validation of process improvements and changes
  • Professionals skilled in supporting investigations and corrective actions.
    — “supporting investigations and corrective/preventive actions

Things to consider

  • Role involves establishing manufacturing operations on the East Coast.
    — “establishing manufacturing operations on the East Coast
  • Focus on clinical pipeline advancement and future commercial availability.
    — “advancing our clinical pipeline and supporting future commercial availability

How to stand out

  • Highlight specific examples of process monitoring in biotech.
    — “process monitoring and troubleshooting
  • Demonstrate experience with high-precision cell therapy products.
    — “high-precision cell therapy products
  • Showcase past work in life cycle management of drug products.
    — “life cycle management of clinical and commercial products
Pace · SteadyCollaboration · MediumAutonomy · MediumDecision Impact · TeamLevel · Senior

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

What success looks like

  • improves efficiency and safety of drug product manufacturing process
  • implements and validates process improvements
Typical background
MSAT Process Engineer experienceknowledge of cell therapy manufacturing

Skills & requirements

Required

Manufacturing Process ImprovementProcess MonitoringTroubleshootingValidationInvestigationsCorrective/preventive Actions

Preferred

Cell Therapy KnowledgeHigh-precision Manufacturing

Stack & domain

Manufacturing ProcessProcess MonitoringTroubleshootingProcess ImprovementsValidationInvestigationsCorrective/preventive ActionsCell TherapyStem Cell TransplantAllogeneic Stem Cell TransplantGraft Vs. Host DiseaseHigh-precision Cell TherapiesProblem-solvingCollaborationCommunicationTeamworkQuality AssuranceBiotechnologyManufacturing OperationsClinical PipelineCommercial AvailabilityLife-saving Therapies

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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