OBJECTIVE OF THE POSITION:
The Scientist or Sr. Scientist will play a key role in the initiation and development of IVD assays based on our molecular ddPCR and NGS platforms. Bench experience with assay development in oncology for IVD using the currently available NGS and ddPCR technologies is required. The position will require knowledge of the studies required for IVD submissions and experience designing and executing development plans under design controls to meet FDA submission requirements. Duties will also include routine trouble-shooting, development of QC measures for monitoring instrument and assay performance, and participation in risk analyses. Participation in meetings with partner and with state and federal regulatory agencies is expected.
The successful candidate will be expected to contribute both as an individual, and as part of a Product Development Core Team. Presentation of findings at internal and external meetings and contribution to written technical reports and publications is expected. On-going training will be provided to supplement key skills required to perform the functions of this position as applicable.
Biodesix maintains a culture of transparency and requires that all team members are willing and open to share data and technical knowledge, practice superior cross-departmental communication skills that are aligned with the Biodesix cultural beliefs, and to execute toward on-time delivery of complete and quality results.
· Provides critical bench strength related to IVD validation of molecular technologies leading to FDA submissions.
· Documents all laboratory activities with compliance to quality systems.
· Works at the bench with support from Research Associates and Scientists to execute on studies required for FDA submission.
· Writes technical plans, protocols and reports supporting analytic instrument and assay performance.
· Clearly presents and discusses data to any level of the organization including technical staff and management.
· Provides technical mentoring and expertise to Lab staff specifically regarding assay development execution and FDA readiness.
· May perform other duties as required or assigned.
COMPETENCY OR POSITION REQUIREMENTS:
· Ability to work within Design Control principles in the development of test products implemented in a regulated Laboratory.
· Expertise in state-of-the-art methods development in Clinical molecular assays including ddPCR and NGS.
· Able to independently determine and develop scientifically-sound solutions.
· Can assume a lead role in team efforts for technical evaluation, including technical components of risk analyses.
· Superior written and verbal communication skills.
· Ability to set, communicate, manage and meet deadlines.
· Demonstrated ability to comply with required established testing procedures, laboratory safety procedures, and HIPAA.
· Proficient in laboratory handling of human specimens.
· Excellent laboratory technical skills with various molecular and pre-analytic techniques including sample preparation and trouble-shooting.
· Strong data evaluation skills. Proficient in computer skills including management of NGS data, other scientific data and common statistical analysis tools.
Appropriate designees may act as responsible delegates according to the Biodesix Quality Matrix.
EDUCATION AND EXPERIENCE:
· PhD or MS in Chemistry/Molecular Biology/Biochemistry, or closely related field. Position title will be benchmarked based on demonstrated laboratory experience and scientific competency in the development of design controlled IVD validation studies.