Vice President – Assay Development
Status: Full Time (Regular)
Primary Location: Company Office (Downtown Detroit)
Secondary Location: Wayne State University Research Laboratory (Detroit)
Overview
Responsible for program management, assay development, clinical studies and talent development/management for R&D and laboratory functions. Responsible for establishing product development roadmap and project milestones consistent with the company expectations. Requires extensive experience with developing an Invitro Diagnostic (IVD) from concept through FDA submission.
Key Responsibilities
• Responsible for establishing product develop roadmap and project milestones consistent with company expectations
• Responsible for program management, managing all external development partnerships and suppliers to deliver products to market on time
• Develop Experimental Design and standardized protocols to help Seraph Biosciences grow in technical experience and discipline
• Mentor existing lab staff
• Present technology and product development strategy and progress to investors, customers, and Board of Directors
• Ensures strategic planning process for the company’s business. Ensures market and competitive forces are appropriately considered with regular review and updates to the plan
• Lead design reviews, data analysis, documentation and design controls.
• Represents the scientific perspective on the Company’s Executive Leadership Team and provides scientific input for decisions that strategic direction
• Inform Executive Leadership team on current scientific trends and market
• Collaborate closely with the VP Engineering, CSTO, CEO, COO and Board of Directors, in addition to external partners and customers
Qualifications
• Expert knowledge of life sciences and in vitro device markets
• Accomplished product development leader with broad cross-functional acumen in engineering and In Vitro Diagnostics development
• Proven experience in design controls, cGMP standards, and working with external development partners
• Skilled in design and integration of complex IVD systems including mechanical, electrical, and fluidics hardware, firmware, software, and reagents
• Experience developing infectious disease IVD systems is a must
• Capable of critical thinking and decision making
• Exceptional written and verbal communication skills
• Demonstrated customer focus – prior commercial (sales/marketing) a plus
• Flexible and collaborative, with a demonstrated ability to lead a start-up company
• Ability to assess scientific strengths and weaknesses, identify new opportunities and recommend scientific direction. Experience transferring technology from academic institution to commercial environment a plus
• Demonstrated program management skills including command of budgeting and timeline tools such as SmartSheets and MS_Project
• Demonstrated program management skills including command of budgeting and timeline tools such as SmartSheets and MS_Project
• Ability to quickly synthesize complex situations, rapidly problem solve, and communicate to diverse group of investors, management, and staff
• B.S. or M.S with 10+ years’ experience, or Doctoral degree with 7+ years’ experience; experience includes 5+ years in start-up company
• Degree in life sciences, engineering, sciences, or related discipline preferred
EEO & Employment Eligibility
Seraph Biosciences, Inc. is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Seraph Biosciences, Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Company
Seraph Biosciences was created specifically to commercialize Seraspec®, a Raman spectroscopy-based platform technology for real time pathogen detection and identification at the point of care. Seraspec® represents a paradigm shift away from existing methods for identification of dangerous bacterial, viral, fungal, and parasitic infections. Our patent-pending technology and method of detection effectively eliminates the need for costly and time-consuming laboratory-based methods of specimen collection, processing and pathogen identification.
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Please feel free to send completed applications (resume, cover letter & references) to our company email or via mail at Seraph Biosciences, Inc., 1001 Woodward Avenue, Detroit, Michigan 48226.
Seraph Biosciences, Inc. is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.