Exciting, well-funded start-up developing innovative high throughput diagnostic systems that enrich biological cell samples for life science research, cellular therapy, and clinical lab applications. This high profile role reports to the Director of R&D and works with cross-functional teams and Key Opinion Leaders (KOLs) to understand and establish application-specific product requirements, and develop plans for extending the company’s consumables and instrumentation products. This role requires a minimum of three years’ experience in industry, and demonstrated expertise and broad experience with cellular and molecular biology techniques developing medical diagnostic and/or device applications. The Senior Application Scientist works directly with potential customers, clinical advisors, KOLs, and CROs to develop and execute test protocols and studies, and to deploy and support products at investigational sites.
- Work with cross-functional company teams and KOLs to establish application-specific product requirements derived from user needs.
- With guidance from clinical advisors, KOLs, and the Research, Product Development, Clinical/Regulatory, and Marketing teams, research methods and develop assays and experimental studies to benchmark product performance against product requirements and competing products.
- Serve as a key internal VOC (voice of customer) scientific representative in the development and evaluation of product performance, including usability.
- Participate in product deployment to external sites, including contributions to documentation, user training, and oversight of technical deliverables.
- Partner with Field Application Specialists supporting pre-sales pipeline efforts and existing customers.
- Use statistical tools in planning and analyzing internal and external experimental bench and preclinical studies.
- Lead, mentor, and direct the research activities of a small team of scientists and engineers.
- Stay up-to-date on scientific discoveries and introduce new concepts to junior staff.
- Communicate technical issues and risks to the team and propose solutions and mitigation strategies.
- Participate in the preparation for and execution of Phase-Gate and Technical Design Reviews.
- Actively participate in regular technical and project meetings.
- Prepare documents, presentations, and technical publications to support sales and marketing efforts.
- Generate patent disclosures and support IP and regulatory filings.
- Travel up to approximately 20%.
Experience and Qualifications:
- PhD degree, with heavy focus on cellular and molecular biology.
- At least three years of commercial protocol, assay, and application development experience in medical diagnostic devices, in an industrial environment;pre- clinical animal model experience desirable.
- Cross-functional team participation in industry, in at least one commercial product project.
- Working understanding of FDA, GLP, GCP, GMP, and ISO regulations.
- Fluency in flow cytometry, fluorescence microscopy, histology, cell culture, cell-based functional assays, ELISA, PCR, and related techniques.
- Highly proficient with statistical analysis and Design of Experiment software tools.
- Perceptive and diplomatic in working with colleagues and customers at all levels of an organization.
- Demonstrates a sense of urgency and fosters an environment of collaboration.
- Excellent organization, problem solving, and written and verbal communication skills.