Reagent Manufacturing Associate I

About Karius
Karius is a venture-backed life science startup focused on transforming the way infectious diseases are diagnosed.  Combining Next-Generation Sequencing and proprietary data analysis, we can identify over 1,000 pathogens from a single blood sample with typical turnaround time in one business day. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, with a future vision of accelerating clinical trials, discovering new microbes, and reducing patient suffering worldwide.

Position Summary
As a Reagent Manufacturing Associate I you will work alongside scientific leaders in NGS-based infectious disease diagnostics providing meaningful contributions to making an impact in the lives of patients while contributing to the company’s growth and development. You will also have the opportunity to foster process excellence for a state-of-the-art NGS infectious disease diagnostic assay by manufacturing and qualifying reagents for Karius assays (RUO and IVD).
In addition, you will support reagent manufacturing equipment, material management, and ISO 13485-compliant processes, while following procedures in fast-paced environments. The ideal candidate should be Detail-oriented professional with hands-on experience in reagent manufacturing, including handling chemical and biological materials. Knowledgeable in reagent manufacturing equipment, material management, and ISO 13485-compliant processes, with the ability to follow procedures in fast-paced environments. Assist in manufacturing and quality testing of RUO and IVD products, troubleshooting, validation planning and execution, and documentation development and revision.

Why Should You Join Us?
Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s 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 Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is 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:        Sr Manager Manufacturing and Technical Operations
 
Location:          Redwood City, CA (100% on site)
 
Primary Responsibilities
Equipment:
• Assist with equipment qualification (IQ/OQ/PQ),  PM maintenance, and basic troubleshooting of equipment. 
• Perform daily maintenance and maintain records in accordance with ISO13485 requirements.

Validation:
• Assist with planning and execution of validation activities.
• Support reagent stability and shelf life extension testing. 

Production:
• Inventory, material control, production planning: Assist with inventory management: receive, inspect label and store raw materials and components, ensuring accurate lot control, FIFO usage, and traceability in accordance with inventory procedures.Conduct physical inventory counts, cycle counts, and material reconciliations of the raw materials, components, and finished goods.  Maintain an accurate inventory management system. Prepare work orders (including material preparation, staging, line setup, and records for production), verify identity and quality of materials used for manufacturing.

Product Assembly:

• Performing tasks including reagent formulation, filling, assembly, packaging, material handling, in-process quality checks, adherence to safety protocols, accurate documentation, and support for continuous improvement initiatives Print labels using control templates in Bartender or equivalent tool and ensuring adequate process controls.  Perform manual and semi-automated operations for labeling, pipetting, and capping/ sealing across tubes, 96-well plates.  

Quality Testing:
• Perform clinical diagnostic reagent manufacturing in process and lot release  QC testing and data analysis. 

Quality:
• Documentation: Assist in drafting and revising Reagent Manufacturing documentation such as SOPs, batch records, and material specifications.Follow standard operating procedures (SOPs) and work instructions. Maintain detailed and organized manufacturing records, including logs, and batch records per ISO 13485, FDA, cGMP and GDP guidelines. 

• NCE/ CAPAS/ Deviations: Assist in identifying, documenting, and escalating non conformance events. Support root cause  investigations and resolution implementation.
• May be required to perform other duties as assigned.

What’s 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 don't suffice. You will get to see how much your work really matters. 

Travel:          No travel 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
• Bachelor's degree in Biology, Molecular Biology, Genetics or related field preferred. At a minimum  associate's degree in life sciences or related field; or High School Degree/General Education Diploma and 2 years of relevant experience in lieu of Bachelor’s degree. 
• 1+ years of experience in a general laboratory setting through prior job experience, education, or a combination of both.
• A minimum of 0-2 years of experience in manufacturing medical devices 21CFR820 and ISO 13485, cGMP manufacturing environment preferred.
• Strong molecular biology skills; e.g. DNA/RNA purification, nucleic acids hybridization, PCR, qPCR, ddPCR.
• Experience with NGS (preparing libraries, running NGS instruments); NGS data processing is a big plus. Experience with automation (e.g, Hamilton, Bravo) is a big plus.
• Critical thinking, attention to detail, and thorough record-keeping.
• Proficient in the use of Microsoft Office Excel and Word. Experience using ERP systems such as Netsuite is a big plus.

Personal Qualifications
• Ability to work independently and collaboratively with team members.
• Be flexible with tasks and schedules. 
• Strong problem-solving skills with the ability to identify quality issues. 
• Comfortable working in a fast-paced, high-growth company environment, with the flexibility and drive to support evolving priorities. 

• Team player with excellent communication skills.
• Excellent organizational record-keeping and attention to details, effective written and verbal communication skills.
• Strong work ethic to generate high quality products under tight deadlines.

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 individual’s 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 recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities.