Staff Scientist, Manufacturing

About Karius Karius is a venture-backed life science startup focused on transforming the way infectious diseases are diagnosed. Combining Next-Generation Sequencing and cutting edge data analytics, we identify infections caused by over 1,000 pathogens from a single blood sample. By unlocking the information present in microbial cell-free DNA, we are helping doctors quickly solve their most challenging cases, with a vision of accelerating clinical trials, discovering new microbes, and reducing patient suffering worldwide.   Position Summary We are looking for a Staff Scientist to implement and maintain a dedicated manufacturing function within Karius, in support of commercial and research activities. The Staff Scientist will have the opportunity to develop new manufacturing processes, qualification procedures, and tracking systems for assay reagents. Key activities will include designing a dedicated manufacturing space, coordinating interdepartmental activities across the organization to ensure reagent inventory goals are maintained, and providing hands-on technical leadership for reagent manufacturing processes.   Why Should You Join Us? Karius aims to conquer infectious diseases through innovations in genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbes throughout our body, providing clinicians with a 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 and enables them to deliver better care to many otherwise ineffectively treated patients. Our test is the result of 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 at scale.   Reports to: Director of Development   Location:  Redwood City, CA   Primary Responsibilities • Lead the development of scalable reagent manufacturing processes and management systems. • Develop experiments to rapidly and efficiently assess the quality of manufactured reagents. • Provide hands-on technical leadership in manufacturing process development, execution of reagent manufacturing, and inventory management. • Oversee daily operations of the reagent manufacturing department, including but not limited to scheduling, data analysis, troubleshooting, and resolving technical and non-technical issues. • Ensure all operators are proficiently trained on current and new procedures regarding manufacturing reagents, assembling kits, and qualification of assigned reagents, following Good Manufacturing Practices and documenting events following current Good Documentation Practices. • Develop tools for tracking and trending reagent / RUO kit performance. • Collaborate with R&D in developing, transferring, scaling, and validating manufacturing processes and quality control test methods for release. • Support supplier management of critical suppliers, including testing services, reagent suppliers, and manufacturers. • Support management of supply chain, including supplier quality inventory update. • Ensure manufacturing raw material and consumables are adequately stocked.   What’s Fun About the Job? Karius is operating at the edge of what is known to be possible in infectious disease diagnostics. Our reagents and control materials are setting the standard for industry quality. 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 regular 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 • Ph.D. degree in Biological Sciences or related field with a minimum of  5 years of industry experience in reagent/kit manufacturing OR Masters and with a minimum of 8 years of industry experience[1]  • Experience in Next-Generation Sequencing (NGS) is highly preferred. • Demonstrated ability to develop positive working relationships with individuals and teams internally and externally with excellent problem-solving ability. • Strong organizational skills, attention to detail, and ability to manage multiple projects. • Previous experience with startups is a plus.   Personal Qualifications •  Demonstrated ability to manage complex projects with multiple priorities in a fast-paced, team-based environment. •  Must be an excellent communicator and able to balance complex strategic and operational initiatives, including legal/policy and business issues. •  Ability to anticipate and identify potential roadblocks to meeting goals and identify corrective actions. •  Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, sites, and external vendors. •  Must be able to work in a collaborative environment while often independently and consistently demonstrating knowledge, skills, abilities, and behaviors necessary to provide high quality service to both internal and external stakeholders. •  Ability to prioritize and manage deadlines. •  Display a high level of commitment and professionalism and be truly passionate about being on the cutting edge of science to help support and generate the appropriate clinical evidence.   At Karius, we value a diverse and inclusive workplace and provide equal employment opportunity 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.