Notable Labs is looking for a senior product development scientist to develop clinical applications of our ex vivo drug sensitivity testing platform. You’re a development scientist with experience and enthusiasm for translating novel technologies into clinical solutions, who wants to contribute to the goals and strategic direction of both the science team and the broader company. As a key member of the Product Development team at Notable, you will design and lead assay development and validation projects which translate technology developed by our Research & Development team into CLIA tests focused on hematologic malignancies.
What You’ll Do
Product development scientists at Notable must work within cross-functional teams which integrate the various disciplines necessary to build clinically impactful diagnostics (product marketing, quality & regulatory compliance, clinical operations, software, program management, etc). The team will look to your assay development and validation expertise in defining product requirements, setting deadlines for key technical milestones, designing specification and validation studies, and executing the roadmap you help define. This role will entail roughly 60% planning and 40% hands-on lab-based responsibilities.
- Assay Development
- Lead assay development and validation in accordance with FDA’s medical device Quality System Regulation (21CFR820 / ISO 13485:2016)
- Develop and maintain documents related to user requirements, product requirements, and assay validation
- Develop and refine standard operating procedures for CLIA assay protocols
- Develop and execute studies for flow cytometry assay development, including proof-of-concept, feasibility, specification, optimization, verification, and validation
- Process human specimens (blood and bone marrow) to single cell suspension
- Analyze samples and data to characterize both primary immune cell populations and cell lines by multiparameter flow cytometry
- Troubleshoot issues that may arise during assay development
- Cross-functional Leadership
- Manage and oversee the work of a junior product development scientist
- Coordinate design transfer of technologies and protocols from Research & Development to Product Development
- Participate in collaborations with industry and academic partners
- Represent the Product Development team on cross-functional product core teams
- Present at group meetings, company-wide seminars, and international conferences
- Model and foster team culture centered on patient focus, deep collaboration, and growth mindset
- Must have
- Ph.D. in cell biology, cancer biology or other related field with 10+ years of hands-on experience in clinical diagnostic product development
- Strong knowledge of CLIA assay validation requirements
- Proven experience developing and validating assays under Design Control for FDA cleared or approved products
- Excellent experimental design, data analysis and troubleshooting skills
- Strong organization, presentation, and writing skills for both technical and non-technical audiences
- Nice to have
- Experience in therapeutics or diagnostics for hematologic malignancies
- Hands-on experience with multicolor flow cytometry execution & analysis
What We Offer
- Collaboration and learning from experts with diverse backgrounds in drug development, engineering, data science, clinical operations, and patient advocacy
- Collaborative environment with a team dedicated to both your personal and professional growth
- Highly competitive, early-stage company compensation package
- Benefits including health insurance, 401(k), and flexible vacation policy
Notable Labs is a precision medicine company that is developing an ex vivo drug sensitivity prediction platform focused on identifying therapeutic options for relapsed and refractory cancer patients. In June 2020, our team published early feasibility studies with Stanford University demonstrating 85% accuracy (Blood Advances).
Our investors include Builders Venture Capital, Founders Fund, First Round Capital, Y Combinator, B Capital Group, several prominent angels and seed-stage funds, and Accelerate Brain Cancer Cure, a venture philanthropy firm founded by Steve Case. We have offices and a laboratory in Foster City, in the San Francisco Bay Area.
At Notable Labs we value diversity and are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.