Manager, Manufacturing Sciences & Technology (MSAT)

Orcabiosystems
Sacramento, US
On-site

Who this role is best for

Aimed at mid-level biotech engineers who oversee clinical and commercial production processes in a manufacturing facility.

Best fit for

  • Experienced process engineers comfortable with regulatory compliance in cell therapy manufacturing.
    — “continuous improvement of manufacturing processes and technologies to ensure product quality, efficiency and compliance with regulatory standards
  • Leaders capable of managing teams across multiple shifts in a high-precision production environment.
    — “leading Manufacturing Science and Technology process engineers, across several shifts, within the commercial manufacturing site
  • Professionals with a track record in tech transfer and process optimization for biologics.
    — “tech transfer and continuous improvement of manufacturing processes and technologies

Things to consider

  • Requires oversight of deviations and corrective actions in a regulated manufacturing setting.
    — “oversees the day-to-day MSAT operations to support clinical and commercial production, deviations, product impact assessments, change controls, CAPAs
  • Involves working in a large-scale facility dedicated to cell therapy production.
    — “100,000-square-foot manufacturing facility in Sacramento, CA

How to stand out

  • Demonstrate experience with risk assessment frameworks in biopharmaceutical manufacturing.
    — “risk assessment, tech transfer and continuous improvement
  • Highlight leadership in cross-functional teams managing commercial-scale production.
    — “leading Manufacturing Science and Technology process engineers, across several shifts
  • Showcase specific improvements you've driven in process efficiency or compliance.
    — “continuous improvement of manufacturing processes and technologies to ensure product quality, efficiency and compliance
Pace · SteadyCollaboration · HighAutonomy · MediumDecision Impact · TeamLevel · Manager

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

What success looks like

  • Lead Manufacturing Science and Technology process engineers
  • Support clinical and commercial production
  • Ensure product quality and compliance
Typical background
Manufacturing ScienceBiotechnology

Skills & requirements

Required

Manufacturing ScienceTechnology TransferProcess EngineeringChange ControlCAPARisk AssessmentContinuous ImprovementRegulatory Compliance

Preferred

Cell Therapy ManufacturingBiotechnology

Stack & domain

Manufacturing Science And TechnologyProcess EngineeringClinical And Commercial ProductionDeviationsProduct AssessmentsChange ControlsCapasRisk AssessmentTech TransferContinuous ImprovementRegulatory StandardsManufacturingCell TherapiesBlood CancerStem Cell TransplantAllogeneic Stem Cell TransplantGraft Vs. Host Disease

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 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 Manager, Manufacturing Science and Technology (MSAT) is responsible for leading Manufacturing Science and Technology process engineers, across several shifts, within the commercial manufacturing site. This role oversees the day-to-day MSAT operations to support clinical and commercial production, deviations, product impact assessments, change controls, CAPAs, risk assessment, tech transfer and continuous improvement of manufacturing processes and technologies to ensure product quality, efficiency and compliance with regulatory standards.

Source: Orcabiosystems careers (Lever)

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