Person, Text, Face

 

Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.

 

Sr Application Scientist

  • North Carolina, United States
  • Full Time

About the Job

The Senior Application Scientist is a key member of the Laboratory Operations Team at Foundation Medicine and provides onsite assay and process optimization and technical support for Next Generation Sequencing (NGS) based clinical assays. This position works in a lab environment around the presence of chemicals and reagents.

This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.

Key Responsibilities

• Initiate, execute, and direct investigations into Clinical Lab performance issues and communicate findings to stakeholders across the organization.

• Lead the successful transfer of NGS and other molecular-based assays and processes to the CLIA/CAP/FDA regulated laboratory facility from internal partners.

• Lead continuous improvement efforts by generating detailed reports summarizing assay and process performance and determining next steps.

• Lead assay qualification (IQ/OQ/PQ) for products, process and instruments.

• Build consensus with stakeholders across the organization based on scientific understanding, data analysis and operational findings when required.

• Author technical and scientific sections of various QMS documentation (CAPA, NCR, etc.) based on Quality and Regulatory frameworks (CAP, CLIA, ISO, FDA).

• Independently gather data from multiple data systems; wrangle data and combine disparate data streams to drive investigations, decision making and insights.

• Supervise interns and/or other junior members of the Product Care group.

• Make technical decisions that can have an impact across Lab Ops organization.

• Serve as a SME for the Lab Ops organization.

• Hold a technical leadership role on project teams and organizational initiatives.

• Travel domestically up to 10% of the time.

• Other duties as assigned.

Qualifications

Basic Qualifications

• Masters Degree in Molecular Biology, Biochemistry, Genetics, Biomedical Engineering, or other scientific field of study

• 7+ years working in industry and/or academia

• 4+ years of hands-on experience with next generation sequencing and associated methodologies to analyze solid and liquid oncology specimens, including DNA and RNA sequencing protocols

Preferred Qualifications

• Strong experience with DNA/RNA extraction and library construction methodologies

• Strong experience with target-enrichment approaches such as hybrid capture and multiplex PCR

• Experience driving the systematic optimization and troubleshooting of complex molecular diagnostic and NGS-based assays through integration of information related to the input sample, lab processes and data analysis pipeline

• Expertise creating and optimizing robust protocols for use in high throughput laboratory automation systems

• Formal training and experience operating in a Laboratory Information Management Systems (LIMS)

• Experience with NGS analysis of solid and liquid biopsies

• Experience with common NGS data management and analysis tools (e.g. SAMtools, IGV/Picard, Python/Perl, R)

• Experience utilizing tools such as RCA, SPC and LEAN frameworks to drive improvements to process and aid in investigations.

• Understanding and Application of Quality and Regulatory requirements of governing bodies (CAP, CLIA, ISO, FDA)

• Demonstrated experience using various Statistical and Analytics approaches to assess performance

• Demonstrated history of work in a fast-paced environment with changing and competing priorities

• Excellent time management, organizational capabilities and attention to detail

• 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

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

 

About Foundation Medicine

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

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