About Us



Associate Director, Product Development
·         Directs research and development of multiple projects within area of the company business objectives. Analyzes data, identifies and evaluates fundamental issues, provides strategy and direction for major functional areas through assessment of intangible variables with projects in various phases. Key technical support for commercialization, such as planning and executing of the clinical study plans, and interacting/supporting with regulatory affair agency, which leads to successful FDA cleared/approved or CE marked products.
·         Responsible for meeting project milestones, for the quality of the scientific approach and for compliance with company quality processes. Works with other departments to facilitate the successful completion of the projects.
·         Responsible for overall program plans and resource allocation within area of responsibility.
·         Interfaces with product development, production/manufacturing and marketing groups to assure new and existing product production in place (schedule, inventory, quality, labeling/packaging, shipping and cost).
·         Stimulates publications and presentations of scientific research. Participates and supports development of key patents for the Company on an ongoing basis.
·         Serves as technical resource for cross-functional teams
·         May act as a technical advisor for specific products
·         May supervise one to several Assay Development research associates or scientists, with the primary function to generate new products. Carries out supervisory responsibilities in accordance with the organization's policies. Responsibilities include resolving problems as they related to research projects; participating interviewing, hiring, and training Assay Development employees; assisting planning, assigning, and directing work; appraising performance; rewarding, training, and disciplining direct reports when needed within the Assay Development program.
·         Works with VP of Assay Development to ensure project strategic plans align with the corporate goals and long-term company plans.
·         Requires a PhD in molecular biology, biochemistry, genetics or related discipline with 6-8 years of experience in development of FDA cleared/approved or CE marked molecular diagnostic products.
·         2-4 years of clinical study experience including planning and executing of the plan and interacting/supporting with regulatory affair agency which lead to successful development of FDA cleared/approved or CE marked products.
·         6-8 years of experience with molecular diagnostics, in particular quantitative real-time PCR
·         Experience with strategic planning with ability to define execution of various programs and projects
·         Motivated to lead and handle multiple projects effectively with fair project management skills. Meet timelines by prioritization of resources without detriment of quality.  
·         Ability to mentor and guide members of the group to promote their career advancement
·         Ability to develop and write specifications, risk assessments, technical plans, timelines, budgets and justifications for complex projects
·         Ability to write and edit critical technical documents
·         Ability to work closely and effectively with upper management
·         Previous project management experience is required
·         Excellent communication skills and interpersonal skills with a demonstrated ability to work well in a team-oriented environment
·         Must be highly motivated, show initiative/independence, and be driven to make important contribution
·         Flexible with sense of urgency

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