ABOUT THE COMPANY:
Inflammatix, Inc. is a venture-backed diagnostics company bringing the power of precision medicine to the point of care. We are building novel diagnostic, prognostic, and predictive HostDx™ tests that combine rapid detection of host mRNA panels with advanced machine learning and computational biology. These tests will be performed on our rapid, point-of-care, isothermal molecular platform instrument currently under development. Our late-stage products, HostDx-Sepsis and HostDx-Fever, focus on enabling physicians to better diagnose acute infections and sepsis. Inflammatix is further developing a pipeline of groundbreaking tests that take advantage of our expertise in reading the immune system.
JOB DESCRIPTION: Director of Assay Research and Development
The Director of Assay R&D will oversee wet lab personnel in the development of our sample-to-answer isothermal quantitative RNA assays. The role will work closely with engineering and machine learning departments to drive the development of assay chemistry and support translation of assays onto our microfluidic cartridge. The successful candidate will implement GLP and ISO:13485 in support of FDA clearance and CE Mark of Inflammatix products, and will see their assays translated to the clinic. He or she will also oversee early-stage next-generation assay work. The role reports directly to the CTO.
- Manage all aspects of BSL-2 wet lab functions related to assay research and development
- Organize and prioritize assay R&D activities to meet project milestones on time and on budget
- Work with engineering, clinical affairs, machine learning, and quality departments to ensure assays meet customer and product requirements
- Oversee external partnerships related to assay development and transfer
- Work with quality department to implement R&D components of Inflammatix quality management system under GLP and ISO:13485 guidelines
- Manage studies, reporting, and documentation required to support FDA clearance and CE Mark of Inflammatix products
- Develop laboratory infrastructure to support continued growth and expansion of the product menu
- Ensure compliance with state and federal environmental health & safety regulations
- Oversee experimental assay research for next-generation products
- Manage a team of ~6 people and continue to build a world-class R&D team
- 5+ years of industry experience in the diagnostic assay and/or device development
- Experience taking IVDs through product launch and providing technical leadership for on-market products
- In-depth understanding of common molecular biology and biochemistry techniques
- Experience with nucleic acid extraction methods for multiple sample types
- Experience with qRT-PCR and/or loop-mediated isothermal amplification (LAMP)
- Track record of managing successful projects, including external partnerships
- Working knowledge of 21 CFR 820, ISO:13485 Quality System requirements and risk management processes (e.g. ISO:14971)
- Experience in a start-up environment aligning multiple strategies and ideas
- Track record of recruiting, building, and managing strong teams
- Strong interpersonal skills working with peers and cross-functional teams
- Ph.D. in molecular biology, biochemistry or related field
ADDITIONAL RELEVANT QUALIFICATIONS:
- Experience with government contracting experience
- Experience implementing laboratory automation
COMPENSATION AND CLASSIFICATION:
- Classification: Full-time position located at our Burlingame, California headquarters
- Compensation: Competitive and commensurate with experience; includes equity package.
- Benefits: Medical, dental, and vision; 401(k) and more.
HOW TO APPLY: Please forward a cover letter and resume to: email@example.com