About the Job

The Application Scientist plays a key role in a new chapter of our organization, providing onsite assay optimization and technical support for Next Generation Sequencing (NGS) based and quantitative immunochemistry clinical assays. This individual will work closely with the Director of Lab Operations and the Director of Operational Systems to ensure seamless technical transfer, implementation, improvement, monitoring and troubleshooting of assays. The Application Scientist supports automation initiatives within the key domains of in-vitro diagnostics manufacturing to support implementing and optimizing automated systems to streamline the production of diagnostic reagents; and automation of sample processing workflows in the CLIA compliant lab. This role requires an analytical mindset, strong interpersonal skills, and a dedication to maintaining operational efficiency and compliance. The ideal candidate will collaborate with cross-functional teams and external partners to ensure the smooth execution of lab processes and maintenance of high-quality standards. 

The incumbent of this role will join a dynamic and rapidly expanding team, with the unique opportunity to contribute to the development and implementation of testing processes from the ground up, 

This position requires working in a lab environment around the presence of chemicals and reagents. The position requires the ability to travel nationally (10%). 

Key Responsibilities

• Technical support and troubleshooting: 
  • Provide technical support during regular operations and troubleshooting on Next Generation Sequencing (NGS) based and quantitative immunochemistry clinical assays, the workflows, instrumentation, automation, and process monitoring therein. 
  • Identify, investigate, and resolve complex product performance issues within laboratory operations and customer-facing applications. 
  • Develop root cause analysis (RCA) and corrective/preventive actions (CAPA) to resolve technical issues. 
  • Support failure analysis for NGS workflows and systems, including reagent kits, instruments, and software. 
• Process optimization and Continuous Improvement 
  • Assist with the effective transfer of NGS and other molecular-based assays and processes from development to the CLIA/CAP regulated laboratory team. 
  • Optimize protocols for sample preparation, library preparation, sequencing, and data analysis. 
  • Design and execute experiments to improve existing workflows, reduce variability, and increase throughput. 
  • Generate and analyze data, summarize findings, and make recommendations to improve product reliability and operational efficiency. 
• Cross-functional Collaboration 
  • The Application Scientist collaborates cross-functionally with dedicated teams in IVD reagent manufacturing and CLIA-compliant clinical laboratory operations, ensuring that automation initiatives are designed and implemented in alignment with the distinct regulatory, operational, and quality requirements of each domain. 
  • Collaborate with the Product Development, Process Engineering, Technology, Development Operations, Laboratory Operations, Bioinformatics, Quality Assurance and Regulatory teams to assist with assay and process development. 
  • Support new product introduction (NPI) initiatives by participating in design transfer and validation activities. 
  • Contribute to product obsolescence, replacements, and change management processes. 
  • Act as a liaison between internal and customer facing teams. 
  • Provide technical support, training, and education-focused presentations to internal stakeholders and, when necessary, customers. 
• Documentation and reporting 
  • Author and review technical documentation, including work instructions, protocols, instrument qualifications, technical reports, and troubleshooting guides. 
  • Document non-conformance reports (NCRs), corrective and preventive actions (CAPAs), and other quality system records. 
  • Generate detailed reports summarizing assay and process performance. 
  • Support regulatory and quality audits as a technical representative. 

Qualifications

Basic Qualifications

• Option 1: 
  • PhD in Molecular Biology, Biochemistry, Genetics, Biomedical Engineering, or a scientific field of study and 
  • 2+ years Hands-on experience with next generation sequencing and associated methodologies to analyze solid and liquid oncology specimens, including DNA sequencing protocols. 
• Option 2: 
  • Master’s degree in Molecular Biology, Biochemistry, Genetics, Biomedical Engineering, or a scientific field of study and 
  • 5+ years working in industry and/or academia including: 
  • 2+ years Hands-on experience with next generation sequencing and associated methodologies to analyze solid and liquid oncology specimens, including DNA sequencing protocols. 
• Option 3: 
  • Bachelor’s degree in Molecular Biology, Biochemistry, Genetics, Biomedical Engineering, or a scientific field of study and 
  • 7+ years working in industry and/or academia including: 
  • 2+ years Hands-on experience with next generation sequencing and associated methodologies to analyze solid and liquid oncology specimens, including DNA sequencing protocols. 
  • 1+ years Hands-on experience with immunochemistry assays 

Preferred Qualifications

• Strong experience with target-enrichment approaches such as multiplex-polymerase chain reaction and hybrid selection. 
• Experience driving the systematic optimization and troubleshooting of complex molecular diagnostics, NGS-based assays, and Immunoassays. 
• Detailed knowledge of regulatory requirements for In-vitro Diagnostics (regulations established by the Food and Drug Administration) and clinical testing in CLIA (Certified Laboratory Improvement Amendments) regulated Laboratories. 
• Excellent time management, organizational capabilities, and attention to detail. 
• Demonstrated history of work in a fast-paced environment with changing and competing priorities. 
• Strong communication skills, demonstrated by a history of complex technical information sharing to internal and external stakeholders in various formats including reports, presentations, and publications. 
• Expertise creating and optimizing robust protocols for use in high throughput laboratory automation systems. 
• Experience with common NGS data management and analysis tools (e.g. SAMtools, IGV/Picard, Python/Perl) 
• Experience using Business Intelligence (BI) tools such as Power BI, Tableau, and Tibco Spotfire to drive information gathering and decision making. 
• Ability to work well under pressure while maintaining a professional demeanor 
• Ability to travel up to 10% 
• Commitment to combining FMI's values: passion, patients, innovation, and collaboration, with the group’s focus on specific aspects of these values, as we aim for rapid decision making, high accountability, willingness to carry uncertainty and to work across swim lanes. 

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