Sr. Manager, Manufacturing and Technical Operations jobs in United States
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Karius · 1 month ago

Sr. Manager, Manufacturing and Technical Operations

Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. The Senior Manager will lead the Manufacturing and Technical Operations team, overseeing the manufacturing lifecycle, driving the development of infrastructure, and providing technical leadership to optimize reagent manufacturing workflows.

BiotechnologyGeneticsHealth CareInformation TechnologyLife SciencePrecision Medicine
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H1B Sponsor Likelynote

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, capacity planning, equipment evaluation, and long-term operational scalability
Drive continuous improvement initiatives to enhance efficiency, reliability, and cost-effectiveness across manufacturing operations
Manage a team of Senior Research Associates and Scientists, providing mentorship, technical guidance, performance management, and professional development

Qualification

Molecular BiologyNext-Generation SequencingReagent ManufacturingAssay DevelopmentQuality ControlContinuous ImprovementTeam LeadershipProject ManagementInterpersonal SkillsCommunication Skills

Required

Ph.D. in Biological Sciences or a related field with 8-10 years of experience in Development, Biotech, Technical Operations, or Reagent Manufacturing, including 3–5 years of people management experience
Extensive experience in assay development within molecular diagnostics or related applications in LDT or RUO settings
Extensive hands-on experience with Next-Generation Sequencing (NGS) and nucleic acid–based reagent development or manufacturing is required
Demonstrated ability to lead and develop a growing team, with strong interpersonal skills and the ability to build effective working relationships across internal and external partners
Strong organizational skills, attention to detail, and a proven ability to manage multiple projects, timelines, and priorities in a fast-paced environment
Demonstrated ability to lead and deliver complex manufacturing programs with multiple priorities in a dynamic, team based production environment
Proven track record as an excellent communicator who can balance strategic and operational initiatives, including compliance, quality, safety, and broader business considerations
Ability to proactively anticipate and identify potential risks or roadblocks to meeting production, quality, and cost goals and implement effective corrective and preventive actions
Excellent written and verbal communication skills, including the ability to clearly present information and respond to questions from executive leadership, cross functional teams, manufacturing sites, and external partners
Able to foster a highly collaborative environment while working independently when needed, consistently demonstrating the leadership, judgment, and behaviors required to deliver high quality service to internal and external stakeholders
Strong ability to prioritize, manage competing deadlines, and allocate resources across multiple projects or production lines
Demonstrated success leading and scaling a growing team, including hiring, onboarding, and developing a high performing group
Displays a high level of commitment and professionalism and is genuinely passionate about advancing cutting edge manufacturing solutions to reliably deliver high quality products that support patient and customer needs
Demonstrated experience driving continuous improvement in manufacturing processes and contributing to manufacturing strategy, capacity planning, and scalability to support company growth

Preferred

IVD experience is highly preferred
Prior experience in a startup or high-growth company is highly preferred

Company

Karius

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Karius delivers genomic insights into infectious diseases, helping clinicians make critical, life-saving treatment decisions.

H1B Sponsorship

Karius has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2021 (4)

Funding

Current Stage
Growth Stage
Total Funding
$354M
Key Investors
SoftBank Vision FundOxford Finance LLCDCVC
2024-05-02Series C· $100M
2020-02-24Series B· $165M
2018-11-30Debt Financing· $25M

Leadership Team

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Alexander Ford
Chief Executive Officer
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Tim Blauwkamp
Chief Scientific Officer, Co-founder
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Company data provided by crunchbase