Sr. Manager, Manufacturing and Technical Operations

Redwood City, CA - USA

Monthly Salary: Not Disclosed

Posted on: 21 hours ago

Vacancies: 1 Vacancy

Job Summary

About Karius

Karius is a life science venture-backed clinical metagenomics company focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.

Summary

We are seeking a Senior Manager to lead Kariuss growing Manufacturing and Technical Operations 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.

Why Should You Join Us

Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The companys platform is already delivering unprecedented insights into the microbial landscape providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our tests are the result of some incredible work done by our scientists statisticians engineers and physicians all driven by the same mission. You as part of the Karius team will be able to see how directly your work has a life-changing impact on people and at scale.

Reports to: Senior Director Assay Development and Manufacturing

Location: Redwood City CA

Primary 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.

Whats Fun About the Job

Karius is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that comes a wave of new and incredible challenges and opportunities. To deliver on that value you will be tapping into some of the most advanced technologies architecting and innovating where the current solutions simply dont suffice. You will get to see how much your work really matters.

Travel: No regular travel is required.

Physical Requirements

Subject to extended periods of sitting and/or standing vision to monitor and moderate noise levels. Work is generally performed in an office lab or clinical environment.

Position 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 35 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 acidbased 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.

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

Personal Qualifications

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.

Disclaimer

The above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties responsibilities and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.

Equal Opportunity Employer

At Karius we value a diverse and inclusive workplace and provide equal employment opportunities for all applicants and employees and are committed to honor and invest in the full diversity of people in our hiring recruiting and development of employees across the Company. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individuals race color sex gender identity and gender expression (including transgender individuals who are transitioning have transitioned or are perceived to be transitioning to the gender with which they identify) religion age national origin or ancestry citizenship physical or mental disability medical condition family care status marital status domestic partner status sexual orientation genetic information military or veteran status or any other basis protected by federal state or local laws. If you are unable to submit your application due to a disability please contact us at emailprotected and we will accommodate qualified individuals with disabilities.

$163611 - $245417 a year

Required Experience:

Manager

About KariusKarius is a life science venture-backed clinical metagenomics company focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics ...