Director of Engineering
Intabio, Inc. is a Series A funded, early stage company developing analytical solutions to transform biotherapeutic development and manufacturing with products that provide early product quality characterization and profound efficiency gains across all stages of biopharmaceutical development and manufacturing. Intabio's first product, the Blaze system, will provide rapid detection and identification of subtle protein modifications - modifications that can undermine the stability and efficacy of biotherapeutic drugs such as monoclonal antibodies and recombinant proteins. Our innovative core technology is the first to utilize microchip functionality to integrate (1) separation of protein isoforms by capillary isoelectric focusing, (2) 280-nm imaging of protein isoforms for quantitation, and (3) electrospray ionization for delivery of the separated isoforms to an adjacent mass spectrometer.
Intabio, Inc. has an immediate opening for a Director of Engineering in Newark, CA. This high-impact individual will lead hardware development for Intabio’s first commercial platform, an analytical system that utilizes a proprietary microchip technology to separate, quantitate, and transfer intact biotherapeutic proteins by electrospray into a mass spectrometer (MS) for molecular identification. The Director of Engineering will oversee internal engineers, expert contractors, and commercial design/manufacturing teams to bring Intabio’s products to market in an efficient, timely manner. The Director of Engineering reports to the Vice President, Product Development.
Lead planning and execution of hardware design planning, design verification and validation, prototype testing, and technology transfer to manufacturing.
Direct the activities of the Engineering team, including external contractors.
Tightly manage development projects contracted to external design firms.
Hire outstanding performers to fill gaps in the Engineering team.
Plan, prioritize and assign workload of the Engineering team. Ensure Engineering deliverables, timelines, marketing specifications, and budgets are met.
Provide technical and scientific guidance to address engineering challenges.
Lead the engineering development process with design reviews, document control systems and system engineering principles.
Oversee engineering partnerships with external MS suppliers.
Bachelor’s degree or higher in Engineering or physical sciences.
Minimum of 7 years’ experience developing laboratory instrumentation for life science applications, with at least 3 years in a technical management position.
Proven track record of leading mechanical/optical development of technically and commercially successful instrument/reagent system products.
Experience leading development of microfluidic, electrophoresis and liquid handling products highly desired.
Experience managing projects with commercial design houses.
Experience with Solidworks and/or ProEngineer CAD system.
Must be a hands-on leader engaged with the development team to provide day to day technical direction and guidance.
Expertise with analytic tools and experimental methods in one or more of the following areas: macro/micro fluidic design for molecular analysis, precision opto-mechanical design, heat transfer in instrument packaging and reagent vessels, EMI analysis and suppression, injection molding.
Experience using product development processes and tools to drive and manage product development, including a phased product development process, a design review process, DFMEAs and Microsoft Project.
Demonstrated ability in diligent documentation/ERP and incorporating integral quality standards into product development.
Ability to maintain the highest standards of integrity for reporting scientific and clinical data.
Excellent verbal and written communications skills, as well as strong organizational leadership skills are required.
Knowledge of GMP’s, ISO and FDA guidelines related to industry.