Sr. Manager, Manufacturing and Technical Operations at Karius

Redwood City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Biotechnology, DiagnosticsIndustries

Requirements

Strong operational excellence
Deep technical expertise in molecular biology
Ability to build and scale robust, compliant manufacturing processes supporting clinical, analytical, and commercial needs

Responsibilities

Oversee daily operations of the reagent manufacturing function, including manufacturing scheduling, production execution, qualification testing, data analysis, troubleshooting, and resolution of technical and non-technical issues
Lead the design and development of manufacturing infrastructure and management systems
Provide hands-on technical leadership in manufacturing process development, qualification testing method development, and inventory management
Develop, implement, and maintain tools and systems for tracking, trending, and reporting reagent and kit performance over time
Collaborate with R&D to transfer, scale, and validate manufacturing processes and quality control test methods for product release
Create and maintain manufacturing documentation, including batch records, job aids, qualification protocols, operating procedures, and design change controls, in compliance with ISO 13485 quality system requirements
Collaborate with Procurement and Quality to support management of key suppliers and external manufacturers, including supplier quality oversight, vendor change assessments, secondary vendor evaluations, and inventory updates
Support manufacturing strategy

Skills

Key technologies and capabilities for this role

ManufacturingProduction PlanningSourcingInventory ManagementReagent ManufacturingQuality ControlMolecular BiologyProcess DevelopmentScalabilityOperational ExcellenceGenomicsAI

Questions & Answers

Common questions about this position

What is the location for this position?

The position is located in Redwood City, CA.

What salary or compensation is offered for this role?

This information is not specified in the job description.

What key skills and expertise are required for this role?

The role requires strong operational excellence, deep technical expertise in molecular biology, and the ability to build and scale robust, compliant manufacturing processes.

What is the company culture like at Karius?

Karius is driven by a mission to conquer infectious diseases through genomic sequencing and machine learning, with a collaborative team of scientists, statisticians, engineers, and physicians focused on delivering life-changing impact at scale.

What makes a strong candidate for this Senior Manager role?

A strong candidate has experience leading manufacturing operations, technical expertise in molecular biology, and the ability to design scalable processes while coordinating cross-functional teams.

Karius

Non-invasive diagnostic tests for infections

About Karius

Karius focuses on medical diagnostics for infectious diseases, offering the Karius Test, which detects over 1,000 pathogens from a single blood sample. This non-invasive test is quick and helps clinicians treat hospitalized patients by reducing the need for multiple invasive tests that can delay treatment. The Karius Test utilizes advanced genomics and artificial intelligence to identify microbial cell-free DNA (mcfDNA) in the bloodstream, providing insights into the pathogens responsible for infections. Karius sells these diagnostic tests to healthcare providers, aiming to offer a faster and less invasive alternative to traditional methods, ultimately saving lives and reducing healthcare costs. The company employs proprietary machine learning algorithms to analyze genomic data in real time, continuously updating its reference genome databases to enhance its diagnostic capabilities.

Redwood City, CaliforniaHeadquarters

2014Year Founded

$311.3MTotal Funding

SERIES_CCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Remote Work Options

Hybrid Work Options

Risks

Competition from AlphaFold 3 could overlap with Karius's genomic insights.

Rapid AI advancements by competitors may outpace Karius's technology.

Reliance on continuous funding rounds indicates potential financial instability.

Differentiation

Karius Test detects over 1,000 pathogens from a single blood sample.

The test uses advanced genomics and AI for rapid, non-invasive diagnostics.

Karius's proprietary algorithms analyze genomic data in real time.

Upsides

Karius secured $100M to expand its test beyond 400 U.S. hospitals.

FDA Breakthrough Device Designation boosts credibility and market potential.

Growing demand for non-invasive diagnostics aligns with Karius's offerings.

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