Job Description

Isto Biologics, a 100% biologics-focused company dedicated to helping patients heal faster, is seeking a Scientist in their Carlsbad, CA facility. With a portfolio comprised of the market-leading autologous concentration device as well as a differentiated bone grafting portfolio that offers functional solutions to meet patient and procedural challenges, Isto is equipped to offer a range of customizable options to surgeons of varying specialties.Biomedical engineer or similar focusing on specific tasks, experiments, and studies under guidance geared towards developing products with tissue engineering / regenerative medicine applications to improve patient outcomes in at least one of the following: sports medicine, orthopedics, general surgery, and / or wound healing.

This position requires a deep functional understanding of various disciplines, including but not limited to immunology, biochemistry, biologics, biomaterials, tissue engineering, and regenerative medicine, along with a passion for advancing cutting-edge science into clinical applications. Day-to-day activities range from running and overseeing experiments to answer technical questions, designing and detailing solutions, managing direct reports, and project management aspects.

Research experience specifically in bone, skin or allograft and allograft processing is required.

Essential duties and responsibilities include:

Research and Development

• Apply engineering and biology-based principles to translate scientifically proven concepts into commercially viable products or to develop new technology platforms for medical applications, under the supervision of Director / CSO.
• Develop laboratory protocols for fabrication of prototypes of medical devices under an existing project with known product specifications.
• Choose or develop appropriate assays or models to characterize product characteristics or predict product performance.
• With or without the assistance from direct reports and with little supervision, execute experiments and studies, collect data, and analyze results. Troubleshoot any unexpected results or issues with assay / model reliability.

Product Development and Sales and Marketing Support

• Work with process engineering to transfer laboratory processes to manufacturing instructions.
• Manage work to create preclinical data packages for use by sales and marketing in the form of brochures, presentations, etc.
• Answer technical questions from sales personnel that arise from the field. This may include running experiments for sales and marketing support to help drive sales post launch.

Documentation

• Document the appropriate evidence necessary to distinguish the relationship among materials, processes, design and product performance in order to build economically efficient systems directed toward a specific medical application.
• Review and approve laboratory documentation of direct reports.
• Publish results in internal reports and present results to upper management and possibly outside collaborators.

Relationships

• Take ownership of all technical aspects of data generation for an existing project. This includes scheduling to stay within a prescribed deadline and keeping budget conscious of overall costs. Report results to supervisor / upper management on a bi-weekly to monthly basis.
• Supervise one or more research associates to assist in projects, as well as provide mentorship and career development.
• Interface with other lab members / groups in R&D to keep a safe, efficient, organized, and cost-conscious laboratory.
• Interface with other departments, including Process Engineering, Operations, and Sales and Marketing, when necessary.

Skills

• Has mastery over experimental design, including but not limited to the concepts of well controlled experiments, statistical power, etc.
• Has mastery of data analysis, including various methods of statistical analysis and meta-analysis, as well as handling large data sets with high levels of accuracy.
• Has mastery over day-to-day logistics of lab operation, including but not limited lab safety, hazardous waste disposal, best lab practices, etc.
• Has mastery over pre-clinical models of various biological processes including but not limited to bone formation, wound healing, angiogenesis, inflammation/immune response required.
• Is familiar with clinical procedures and applications of medical devices in at least one of the following required: sports medicine, orthopedic surgery, general surgery, and / or wound care.
• Is familiar with FDA regulations and able to apply guidelines to designing products and/or processes.
• Is familiar with allograft processing and tissue banking.
• Is familiar with the competitive landscape of similar products and technologies.
• Stays up to date on state of the art in basic science and the commercial landscape.
• Excellent verbal and written communication skills required

Education/Experience

· Ph.D. in bioengineering/ biomedical engineering or related field and up to five years of relevant working post grad experience required.

· M.S. degree in bioengineering/biomedical engineering or related field and a minimum of 5 years relevant experience may also be considered.

· Travel may be required two or more times annually, either for attendance at technical conferences, trips to collaborators for technical support, or trips to customers to serve as a technical expert to customers.

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