Direct product development programs related to assay development using DxTerity’s DxDirect® technology and/or consumables for the FDA-regulated molecular diagnostic market in compliance with FDA and ISO regulations.
- Direct one or more product development programs related to assay using DxTerity’s DxDirect® technology and/or consumables.
- Provide Technical oversight for projects and programs, including critical review of data and technical reports.
- Perform Program related administrative tasks: Manage budgets, manage employee development and performance, allocate resources, oversee project planning and management.
- Ensure activities are consistent with project critical path, and respond appropriately to changing priorities. Manage activities and assigned projects to reach agreed objectives.
- Work closely with team members in a collaborative environment.
- Develop work plans and approaches to deliver results as efficiently as possible.
- Adjust work schedule meet time-sensitive project milestones.
Measures of Contribution/Impact:
Contribution is measured through, but not limited to, timely achievement of program milestones, innovative solutions to meet key customer requirements, successful transfer of products to OEM manufacturers, successful regulatory agency clearances and avoidance of customer inquiries and post-launch product support investigations.
Education and Experience:
Ph.D. in Genetics, Microbiology, Molecular Biology or a related field and at least 5 years program management experience in design and development of clinical diagnostic products in a regulated environment is preferred. M.S degree will be considered, with additional industry experience.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Expertise in genomics and molecular biology, principles of nucleic acid hybridization, probe and primer design, and technologies for amplification of specific gene sequences.
- Experience with product design and development of nucleic acid-based assays for disease detection and diagnosis of disease or development of pharmaceutical products in a regulated environment, preferably in a company manufacturing diagnostics products for the clinical lab and/or doctor’s office market.
- Organizational, planning and detail follow-up skills required. Ability to utilize tasking, scheduling and other project management tools.
- Leadership and motivational talent needed with ability to relate to both highly educated and unskilled team members.
- Ability to handle and resolve conflicts and work under stressful conditions
- Demonstrated ability or track record of successful results
- Ability to understand complex scientific, engineering and business concepts
- Demonstrated ability to be flexible and resourceful. Excellent communication and diplomacy skills.