Product Technical Specialist

Biodesix•De Soto, KS

2h•$83,800 - $90,000•Onsite

About The Position

The Product Technical Specialist supports Biodesix late-stage product concepts under the Quality Management System adhering to product development process. This role includes providing support for integration into laboratory operations as well as on market product support. As an experienced bench scientist, the Product Technical Specialist specializes in developing and executing chromatography, mass spectrometry and ELISA methods, or maintaining and troubleshooting chromatography, mass spectrometry and ELISA related instrumentation. Specifically, the Product Technical Specialist will develop and optimize chromatography, mass spectrometry, and ELISA methods to meet clinical and analytic requirements for our regulated product service diagnostic tests in the regulated Kansas Laboratory. The Product Technical Specialist will carry out preventative maintenance and troubleshooting of chromatography, mass spectrometry and ELISA equipment, and ensure all maintenance activities are completed according to schedule. The Product Technical Specialist will contribute individually and in cross-functional teams. Appropriate designees may act as responsible delegates according to the established Roles and Responsibilities, including day to day responsibilities required for CAP/CLIA and NYS CLEP, as well as all state-specific requirements in which Biodesix is an approved test facility.

Requirements

Outstanding technical laboratory skills
Ability to operate and troubleshoot ELISA, HPLC and LC-MS equipment and processes
Practical and technical knowledge of ELISA, LC-MS and/or HPLC
Excellent verbal and written communication skills
Must be able to prioritize workload according to project timelines with guidance and supervision
Must be comfortable working with diverse levels of scientists and non-scientists to complete product development projects
Must be able to analyze complex and large data sets and develop graphs and/or tables to summarize results
Must be able to interpret results and communicate observations and conclusions in a clear and logical manner in both large and small group settings
Excellent attention to detail with a strong commitment to thoroughness and quality
Exceptional organizational and documentation skills
Knowledge of lab safety and GLP
Basic computer skills required (Microsoft Office suite)
Take initiative and self-motivate to excel
Ability to provide operational guidance and leadership to technical staff
Master’s or Doctoral degree in a chemical, physical, biological or clinical laboratory science or medical technology, with at least 2 years of related experience; or Bachelor’s degree with at least 6 years relevant experience
Experience with ELISA, HPLC and/or LC-MS QQQ required
This role shall comply, at a minimum, with the responsibilities and qualifications outlined in: CLIA: Clinical Laboratory Improvement Amendments (CLIA) Requirements, Title 42 Code of Federal Regulations Part 493
CAP: College of American Pathologists (CAP)
NYS CLEP: New York State Department of Health, Clinical Laboratory Evaluation Program (CLEP), New York State Public Health Law, Article 5 Title 5
All other applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD
Occupational Safety and Health Administration (OSHA)

Responsibilities

Make technical contributions to our fast-paced, dynamic team in developing clinical diagnostics to accelerate the use of proteomic testing for personalized medicine
Comply with the Laboratory Continuing Education program and all other business assigned Trainings required for performance of job requirements
Collaborate and assist in the planning, development and execution of laboratory and product development studies
Perform benchwork including, but not limited to, sample preparation, preventative maintenance of instrumentation and conduct experiments for development of proteomic techniques such as mass spectrometry and chromatography
Maintain proper documentation of all studies conducted in a laboratory notebook following GDP
Ensure proper care in the use and maintenance of equipment and supplies
Carry out preventative maintenance on laboratory equipment and maintain schedules of maintenance activities, according to policies and SOPs
Collaboration with the CAP/CLIA and NYS Laboratory Directors, and with other cross-functional team members in later-stage Product Development, Laboratory Operations, Applications Engineering, Commercial Operations, Legal, Quality and Regulatory
Complete training and Competency Assessment for all new and existing procedures, as applicable
Contribute to the creation and revision of Laboratory SOPs, Protocols, and Reports in the Quality Management System (QMS)
Contribute to the Internal Audit readiness through good documentation practices
Perform all job functions in accordance with HIPAA
Communicate effectively with on-site and remotely located management/support teams
Work independently and with others in a collaborative team environment
All other duties as assigned