Reagent Manufacturing Associate I

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.

Position Summary:
As a Reagent Manufacturing Associate I you will support the production of critical reagents used in Karius NGS-based infectious disease diagnostic assays. This role is hands-on and process-focused with responsibility for manufacturing and qualifying reagents supporting RUO and IVD product workflows performing quality testing and maintaining accurate documentation in an ISO 13485-compliant environment. You will work closely with scientific and operational teams to support equipment readiness material management troubleshooting validation activities and continuous process improvement. The ideal candidate is detail-oriented reliable and comfortable working with chemical and biological materials in a fast-paced manufacturing setting where quality consistency and patient impact are central to the work.

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: Sr. Manager Manufacturing and Technical Operations

Location: Redwood City CA (100% onsite)

Primary Responsibilities:

• Support equipment qualification activities including IQ/OQ/PQ preventive maintenance routine maintenance basic troubleshooting and required documentation in accordance with ISO 13485 requirements.
• Assist with planning and execution of validation activities including reagent stability studies shelf-life extension testing documentation and data review.
• Perform reagent manufacturing activities including formulation filling labeling assembly packaging material handling in-process quality checks and accurate batch documentation for RUO and IVD products.
• Receive inspect label store stage and reconcile raw materials components and finished goods while maintaining accurate lot control FIFO usage traceability and inventory records.
• Prepare work orders stage materials support line setup verify material identity and quality print labels using controlled templates and perform manual or semi-automated operations such as pipetting capping and sealing tubes and 96-well plates.
• Perform in-process and lot-release QC testing for clinical diagnostic reagent manufacturing support data analysis review results for accuracy and completeness and escalate issues as appropriate.
• Follow SOPs and work instructions maintain organized manufacturing records and assist with drafting or revising SOPs batch records work instructions and material specifications.
• Assist in identifying documenting escalating and supporting resolution of nonconformance events deviations CAPAs and related root cause investigations.

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:

• Bachelors degree in Biology Molecular Biology Genetics Chemistry Biochemistry or a related field preferred. An Associates degree in a life sciences field or High School Diploma/GED with relevant experience may be considered.
• 02 years of relevant laboratory reagent manufacturing life sciences production or regulated manufacturing experience.
• Basic hands-on molecular biology experience preferred including DNA/RNA purification nucleic acid handling PCR qPCR and/or related techniques.
• Exposure to NGS workflows reagent manufacturing or regulated environments such as ISOCFR Part 820 cGMP and/or GDP is a plus.
• Strong attention to detail willingness to follow established procedures and commitment to accurate documentation and record-keeping.

Personal Qualifications:

• Ability to work independently and collaboratively with team members.
• Highly goal-driven and have demonstrated the ability to effectively prioritize and focus on time-sensitive objectives.
• Strong problem-solving skills.
• Strong teamwork and motivation skills are essential.
• Strong organizational record-keeping and communication (verbal and written) skills.
• Strong work ethic to generate high quality work under tight deadlines.

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.

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.