Manager, Manufacturing Sciences & Technology (MSAT)
SacramentoOn-siteFull-time
AI Summary
Manages MSAT engineers to oversee day-to-day manufacturing science and technology operations for clinical and commercial cell therapy production, ensuring quality, regulatory compliance, and process improvements.
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 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.
Physical Demands
Work Conditions
Essential Duties & Key Responsibilities:
Minimum Qualifications:
Preferred Qualifications:
Skills
Biologics ManufacturingCAPACell Therapy ManufacturingChange ControlContinuous ImprovementCross-Functional CollaborationData AnalysisDeviationsDocumentationDrug Substance ManufacturingGMPLeadershipManufacturing OperationsPharmaceutical Fill And FinishProcess ValidationProduction TroubleshootingQuality RecordsRegulatory ComplianceRisk AssessmentStatistical Process ControlTeam ManagementTech Transfer
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