Participates and supports the design, development, evaluation and validation of protocols for both clinical testing and translational research using advanced technologies such as but not limited to next generation sequencing in a CLIA designated lab.
Responsibilities:
Designs, validates and maintains quality assurance benchmarks for clinical and translational research protocols.
Works in a team environment and oversees work performed by other lab members in the execution of projects determined by the laboratory director.
Oversees all technical performance of advanced molecular and proteomic technologies such as but not lmited to next generation sequencing for clinical or research utility.
Evaluates new advanced molecular technologies and assays such as but not limited to targeted panels, clinical exome, whole exome and whole genome analysis.
Communicates results in oral and written fashion as presentations at national meetings, local seminars and published abstracts and manuscripts.
Writes and reviews all SOPs as designated by the laboratory director.
Develops and maintains standard operating procedures and documentation for required activities.
Maintains quality assurance and quality control documentation.
Maintains monthly maintenance documentation for all advanced technology equipment and reagents based upon regulatory standards .
Participates in preparation of regulatory and accrediting agencies inspections of the laboratory (i.e., CAP inspection, DHMC safety inspections).
Responsible for Molecular Pathology CAP checklists in Lab general, Molecular Pathology and NGS.
Responsible for QA documentation for NGS and other advanced technologies (i.e., SOP's, databases).
Responsible for Clinical testing proficiency reporting to regulatory agencies (i.e., CAP Surveys for sequencing).
Performs all other duties as required or assigned.
Minimum Qualifications:
Bachelors in genomic or related science with a strong academic record and one year of related lab experience.
Masters in genomic or related science preferred.
An ASCP (MB) certification, or eligibility, preferred.
PhD in genomic or related science with minimum of one-year of post-doctoral training preferred.
Experience with Nucleic Acid Extraction and Purification, Detection Techniques for Nucleic Acids, Nucleic Acid Amplification Techniques (i.e. PCR, RT-PCR, qPCR), Electrophoresis and Capillary Electrophoresis.
Experience with DNA Sequencing.
Must be proficient at routine and preventative maintenance, operation, and trouble shooting for technical and software related issues.
