| Job Description | HTG Molecular is seeking a Senior Staff Scientist for its molecular diagnostic assay development programs. This position supports the Clinical Product Development Program’s assay development from late concept through clinical validation and is located in Tucson, Arizona. Candidates should have a Master’s or Ph.D. degree (preferred) and a strong background in gene expression assays and array technology as well as familiarity with FDA regulatory requirements. The successful candidate will work with a team of development scientists to bring novel molecular assays through validation, FDA approval, and commercialization.
Responsibilities:
Supports molecular diagnostic assay development from late concept through clinical validation.
Works with a group of development scientists to bring novel molecular assays through validation, FDA approval and commercialization.
Collaborates with external research and clinical investigators.
Mandatory Qualifications:
Education/Training: Master’s or Ph.D. (preferred) Degree in Genetics, Molecular or Cellular Biology or related field
Experience:
Minimum 8 years industrial experience
Demonstrated experience managing time and projects to meet deadlines
Experience with product development design controls
Ability to lead teams
IVD product development experience required
Knowledge of (position requirements at entry):
Statistical methods and mathematics.
Assay techniques, such as gene expression assays, array-based assays, ELISA assays, protein assays, including oligonucleotide probe design and use of BLAST.
Automated laboratory instruments (pipettors, wash stations, etc.).
Optical detection and optical probes.
Regulatory requirements such as FDA, GMP, GNP, IND, CLIA.
Skills and Abilities in (position requirements at entry):
Ability to contribute novel ideas to solve problems.
Ability to independently carry out objectives.
Ability to make detailed experimental observations, review and analyze data, and interpret experimental results. |
| | Company | | HTG Molecular Diagnostics, Inc. | Job Code | | State or Province | | Arizona | | |
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