Snapshot of Responsibilities:
- Manages multi-tiered functional organization responsible for development of molecular diagnostic assays and associated enabling technologies
- Works with executive management to prioritize projects and assign resources, communicating resource gaps as necessary
- Works with technical leaders within functional organization to outline development, optimization and design verification plans
- Collaborates with outside groups/companies as needed.
- May participate in cross-functional product development core teams
- Supervises the design, evaluation, and optimization of experiments to develop safe and effective products.
- Applies biochemical, molecular and biophysical techniques to develop measurable parameters to assure reproducibility and stability in product manufacturing
- Designs experiments, evaluates data, communicates results to others and determines subsequent course of action consistent with project and company goals.
- Develops technical staff in the design of experiments and proper use of controls and laboratory notebook keeping.
- Provides expert technical advice on competitor products, new products, and current scientific concepts that may lead to new products. Should maintain ongoing surveillance of marketing, scientific, and patent literature to stay abreast of new developments and products that may impact OraSure Technologies, Inc. business.
- Prepares and presents papers at scientific meetings and/or publishes in scientific journals
- Writes invention disclosures describing patentable inventions arising from work performed
- Determines needs for clinical specimens for product development and participates in the planning of analytical studies
- Assures compliance with all pertinent safety and regulatory policies.
What You Bring:
- Past experience in successful development of molecular diagnostics products released for sale in US and/or international markets
- Demonstrable experience in developing in vitro diagnostic products in the area of infectious disease
- Demonstrable skill in developing clinical sample preparation methods that achieve product design goals under design control
- Demonstrable technical skill and experience in the design and optimization molecular (preferably isothermal) in vitro diagnostic assays
- Familiarity with FDA Quality Systems regulations
- Excellent written and oral communication skills
- Willing to work at the bench to assist in teaching technical skills to subordinates.
- Ph.D. with 12+ years of industry experience, preferably leading in vitro diagnostic assay development teams
- Previous experience in leading technical teams responsible for the development of products or components of in vitro diagnostic assays including assays for infectious disease agents
- Previous experience participating in cross-functional product development teams and investigations.
- Expertise in optimization of formulations and production processes, conduct of Design of Experiments (DOEs) and evaluation of product performance
Top Skills
What We Do
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics.
The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions.
OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers.