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 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 Clinical Laboratory
The Director of Clinical Laboratory will oversee the processing of samples from clinical studies, and will work closely with engineering, assay development, and machine learning departments to drive product development, verification, and validation.
The successful candidate will establish a CLIA/CAP-certified lab and support FDA clearance and IVDR approval of Inflammatix products and will report directly to the CTO.
- Manage all aspects of clinical sample processing and data generation for both registrational (GCP) and non-registrational clinical trials on NanoString and rapid HostDx platforms
- Organize and run Verification and Validation activities for a novel test system with support from CTO
- Implement sample processing automation and scalable, compliant LIMS
- Manage clinical lab reporting and documentation required for FDA clearance and IVDR approval of Inflammatix products
- Develop laboratory infrastructure to support the continued growth of clinical studies
- Write and execute a plan for CLIA/CAP certification
- Ensure clinical lab compliance with state and federal environmental health & safety regulations
- Ensure clinical lab implementation of Inflammatix quality management system
- Manage a team of ~2 people and continue to build a world-class R&D team Build an efficient, world-class clinical lab team
- 5+ years experience as a clinical laboratory scientist performing work in a CLIA certified laboratory
- Master’s degree or higher in chemistry, physics, biology, or clinical laboratory science
- Experience in sample processing automation
- Experience in verification & validation processes required, experience to operate as an FDA-registrational trial site desired
- Experience in establishing LIMS systems
- Experience in complex diagnostic molecular testing techniques, namely qRT-PCR, preferably Loop-mediate Isothermal Amplification, and NanoString nCounter
- Experience with nucleic acid extraction methods for multiple sample types
- Working knowledge of 21 CFR 820, ISO:13485 Quality System requirements and risk management processes (e.g. ISO:14971)
- Successful experience with CLIA/CAP/CMS audits
- 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
COMPENSATION AND CLASSIFICATION:
- Classification: Full-time position located at our SF Bay Area, California headquarters
- Compensation: Competitive and commensurate with experience; including a strong 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