Product Technical Specialist

Biodesix; De Soto (KS); On-site; USD 84,000 - 90,000; Full time

Benefits offered by this job

Health coverage

Disability & Life Insurance

Vacation 120 hours

Sick leave 72 hours

11 holidays + 3 floating holidays

Employee Assistance Program

Voluntary Benefits

Employee recognition program

Job summary

Biodesix seeks a Product Technical Specialist to support late-stage product concepts within a regulated Kansas laboratory. The role focuses on developing and optimizing chromatography, mass spectrometry, and ELISA methods to meet clinical and analytic requirements for diagnostic tests.

You will perform maintenance, troubleshooting, and ensure documentation aligns with GDP and regulatory standards. You will work with CAP/CLIA and NYS CLEP requires, collaborating with cross-functional teams across

Qualifications

• Master’s or doctoral degree with relevant experience in clinical laboratory science.
• Experience with ELISA, HPLC and/or LC-MS methods in a regulated lab environment.
• Strong documentation and GMP/GLP familiarity.

Responsibilities

• Develop and optimize chromatography, mass spectrometry, and ELISA methods for clinical/analytic requirements.
• Perform preventative maintenance and troubleshoot chromatography, MS and ELISA instrumentation.
• Maintain thorough documentation and adherence to GDP and QMS.
• Collaborate across CAP/CLIA, NYS CLEP and cross-functional teams on late-stage product development.

Skills

ELISA

HPLC

LC-MS

Data analysis

Documentation

Communication

Lab safety

Education

MS/PhD in chemical/biological sciences

Tools

ELISA Instrumentation

HPLC Systems

LC-MS Instruments

Job description

Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics.

Our Mission:

Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs.

Our Vision:

A world where patient diseases are conquered with the guidance of personalized diagnostics.

THE ROLE:

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.

WHAT YOU'LL DO:

• 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

WHAT YOU'LL BRING:

• 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
• Education & Experience
• 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)

WORK ENVIRONMENT:

• This role is performed primarily in a laboratory setting, which may include biological, chemical, or analytical work areas
• The environment may involve exposure to chemical reagents, biological samples, fumes, odors, and/or hazardous materials, consistent with standard laboratory operations
• Employees are required to follow all safety protocols, including the use of personal protective equipment (PPE) such as lab coats, gloves, safety glasses, and closed toe shoes
• Work may involve operating specialized laboratory instruments and equipment
• Noise levels are generally moderate but may vary depending on equipment use
• Work hours may require extended or off shift work based on project, testing needs, or assigned work schedule
• Minimal travel

PHYSICAL REQUIREMENTS:

• Ability to stand, walk, or move between workstations for extended periods during the workday
• Ability to manipulate small tools, laboratory instruments, and delicate materials with precision
• Must be able to lift, move, or carry laboratory items or equipment typically up to 25 pounds
• Ability to read, interpret, and record data accurately from instruments, screens, and written materials
• Visual and manual dexterity sufficient to perform tasks requiring close vision, color differentiation, and fine motor control
• May involve occasional bending, reaching, or stretching to access equipment or storage areas
• Must be able to wear required PPE for extended periods, including gloves, safety goggles, and lab coats
• Ability to respond appropriately in emergency situations (e.g., spills, alarms)

WHAT YOU'LL GET:

• Compensation range $83,800 to$90,000
• Discretionary Bonus opportunity
• Comprehensive health coverage: Medical, Dental, and Vision
• Insurance: Short/Long Term Disability and Life Insurance
• 120 hours of annual vacation
• 72 hours of paid sick time off
• 11 paid holidays + 3 floating holidays
• Employee Assistance Program
• Voluntary Benefits
• Employee recognition program

Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.