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JOB SUMMARY
This position is responsible for the research and development of immunodiagnostics assays for the product development group. Responsibilities include directing research/development activities relating to developing new tests and technologies for improving maternal and fetal healthcare. Position will lead Company's product development functions for assay development from proof of concept to assay optimization and/or transfer/scale up for production.
DESCRIPTION OF POSITION RESPONSIBILITIES:
- Works with the Vice President of Product Development and senior management to ensure that assay development milestones and timelines are consistent with the Business/Marketing plan.
- Lead all phases and facets of the development of immuno-based assay development to ensure that key organizational goals are achieved.
- Responsibilities will include design and implementation of the product development plan, experimental design and execution, and analysis and interpretation of data.
- Lead by example, i.e. with a "hands on" technical management style. Build and maintain an effective organization; promote a high performance environment, ensuring that department is appropriately staffed and employees are properly trained.
- Ensure budget, staffing and other corporate/program goals are met.
- Direct, coordinate and allocate scientific resources.
- Identify and assess new markers and technology for application to immunodiagnostics.
- Seek out and participate in external scientific influence, attend scientific conferences and participate in licensing activities.
- Manage and track product development programs.
- Provide support and direction to regulatory product submissions.
- Ensure product development unit complies with design control requirements
- Prepare annual research and development budgets, and manage effective performance versus budget.
- Stimulate publication and presentation of scientific research.
- Develop key patents for the Company on an ongoing basis,
- Interact externally with university-based scientists, customers of the Company and government research organizations.
- Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.
- Perform other related duties as assigned.
RELATED BUSINESS/TECHNICAL SKILLS, KNOWLEDGE, ABILITIES:
- Accuracy and detail orientation extremely important.
- Ability to use independent judgment and to work independently.
- Solid organizational skills and time management skills.
- Excellent verbal and written communication skills.
EDUCATION AND EXPERIENCE REQUIREMENTS:
Requires a Ph.D. in a scientific discipline or equivalent with a minimum of 10 plus years experience in an R & D environment. At least 4 years research and development and clinical experience with immunoassays in the in vitro diagnostics industry. Prior assay development management experience, including the successful transfer from R&D to manufacturing and launch of such products into commercialization. Prior supervisory/management experience of at least five years in managing direct reports. Demonstrated ability to effectively analyze and interpret clinical data and reduce to practice.
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