Scientist, Assay Validation Laboratory Ops - SII

Job Location(s) US-MD-Baltimore
Posted Date 2 months ago(3/16/2022 9:46 AM)
# of Openings
Job ID
Sysmex Inostics


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This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way. improve the lives of others.

Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory. build a promising future. 


Sysmex Inostics, a Sysmex Corporation subsidiary, empowers discoveries in oncology by providing cost-effective and ultra-sensitive quantitative liquid biopsy solutions with groundbreaking digital PCR (OncoBEAM™) and NGS (SafeSEQ) technologies. As pioneers in blood-based cell-free tumor DNA (ctDNA) mutation detection, Sysmex Inostics has provided custom assays and CLIA-certified lab services to leading BioPharma companies over the last 10 years with the overall goal: to develop therapeutics that extend lives and provide diagnostics to monitor response to therapy, identify targetable resistance alterations, and detect minimal residual disease (MRD).
Sysmex Inostics’ U.S. headquarters and CLIA-certified laboratory is based in Baltimore. The European headquarters for research and development are located in Hamburg, Germany.


We currently have a great opportunity available for a Assay Validation Scientist. The Assay Validation Scientist manages technical aspects of all CLIA certified lab work, ensuring that the laboratory meets state and federal guidelines and achieves excellence in quality at every level. Plan and organize the validation for clinical testing assays.


Essential Duties and Responsibilities:


  1. The Assay Validation Scientist will work with the R&D and RA/QA to validate complex genetic tests.
  2. The primary focus of this role is to prepare and organize reports and documentation for validation studies, with occasional contribution toward wet lab activities.
  3. Plan and organize validation studies; write formal validation plans.
  4. Collaborate with laboratory supervisors to optimize laboratory processes for increased efficiency and effectiveness.
  5. Draft technical SOPs and equipment operation SOPs.
  6. Assist laboratory supervisors with creating training programs and forms for new procedures.

Physical Demands: Regular exposure to risk that may require alertness, but with minimal precautions.

Physical Demands. Light physical effort.  Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work.  May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.


  • Bachelor’s Degree and 6 years of experience, not less than 2 years in a clinical laboratory with a director at the doctoral level
  • Master’s Degree and 4 years of experience, not less than 2 years in a clinical laboratory with a director at the doctoral level
  • Molecular biology knowledge and experiences using PCR and Next Generation Sequencing
  • Proficient in Microsoft Office including Word, Excel, PowerPoint. 
  • Good typing and alphanumeric data entry skills required
  • Excellent critical thinking skills to support quality decision-making
  • Proven problem solving/troubleshooting abilities
  • Excellent oral and written communication skills
  • Leadership abilities
  • Ability to provide guidance on analytical issues

Sysmex’s COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by your start date.  To the extent permitted by applicable law, any offer of employment extended will be conditioned upon the individual’s ability to provide proof of current vaccination status.  Sysmex makes reasonable accommodations when needed for medical or religious reasons.  However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job.


Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.


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