Scientist

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.

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 reponse 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.