Sr. Manager, Manufacturing and Technical Operations

Karius•Redwood City, CA

29d•$163,611 - $245,417•Onsite

About The Position

We are seeking a Senior Manager to lead Karius's growing Manufacturing and Technical Operations team. This role oversees the full end-to-end manufacturing lifecycle, including production planning, sourcing, inventory management, reagent and kit manufacturing, and quality control testing for existing products. The Senior Manager will also drive the development of manufacturing infrastructure, new production processes, qualification procedures, and tracking systems that enhance the scalability and robustness of reagent manufacturing. Key responsibilities include designing and establishing a dedicated manufacturing infrastructure, coordinating cross-functional activities to ensure operational goals are consistently achieved, and providing technical leadership to support and optimize reagent manufacturing workflows. The ideal candidate brings strong operational excellence, deep technical expertise in molecular biology, and the ability to build and scale robust, compliant manufacturing processes that support clinical, analytical, and commercial needs.

Requirements

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; IVD experience is highly preferred.
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.

Nice To Haves

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

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.