Knowledge and Critical Skills/Expertise
§ Extensive experience with PCR and other nucleic acid-based technologies including strong knowledge for molecular clinical assay development.
§ Demonstrated expertise in the functional areas of molecular assay development, project management, team building and support for clinical lab compliance.
§ Ability to work in a fast paced growth environment without compromising quality.
§ Ability to write and edit critical technical documents.
§ Ability to innovate new techniques and methodologies utilizing research literatures, team collaboration, and testing new ideas etc.
Position Requirements (Education, Experience, Licensure/Certifications)
§ MS in molecular biology, biochemistry, microbiology, genetics or related science with 3+ years of industry experience in Molecular Assay or Product Development.
§ PhD in Molecular Biology, Biochemistry, Microbiology, Genetics or related science. Direct relevant industry experience in Molecular Assay or Product Development preferred
Tasks, Duties and Responsibilities
· Interacts with physicians, employees and clients in a positive manner consistent with the mission and values of the company.
§ Contributes to the design, modification, and validation of existing and new Laboratory Developed Tests (LDTs) in compliance with CLIA and CAP guidelines.
§ Keeps laboratory notebooks up to date and with sufficient details that results can be reproduced
§ Effectively self-manage all assigned Molecular Assay Development and or Innovation projects/activities
§ Reviews data being generated from the clinical laboratory to identify potential issues and assay enhancements.
§ Reviews and assesses the scientific literature relating to new and existing molecular assays, and provide insight to the Vice President of R&D and/or CEO when new potential assays are recognized.
§ Other duties as assigned.