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About the Job
The Scientist II, Assay Development supports the late-stage development and optimization of next generation sequencing (NGS) based assays in our clinical labs. Leveraging strong working knowledge of molecular biology, the incumbent in this position partners closely with other scientists and stakeholders cross functionally on high throughput automation and advancing NGS.
Regular onsite work at a designated FMI location is an essential function of this role.
• Collaborate with molecular biologists, computational scientists and regulatory scientists to support the feasibility and development of clinical oncology NGS diagnostic assays.
• Competent in complex molecular biology techniques, including NGS workflows
• Strong data analysis interpretation and troubleshooting to identify methods to optimize assay features.
• Design and conduct required feasibility and development and validation work, and help to draft standard operating protocols
• Conduct investigations and analyses to improve assay capabilities and technical robustness, enhance existing methods and complete troubleshooting to optimize assay performance.
• Establish performance specifications for NGS assays and partner with stakeholders for implementation.
• Author detailed, accurate, and accessible records of experimental data and protocols, plans and reports within the Quality Management System as needed
• Monitor and evaluate analytical aspects of new and emerging technologies.
• Present scientific and technical data to colleagues in a clear and cohesive manner that adapts to varying levels of knowledge of recipients.
• Contributes to project team deliverables according to project schedules / timelines
• A combination of the following education/experience requirements:
· (A) Bachelor’s Degree in chemical, physical or biological science or medical technology and 6+ years of industry experience
· (B) Master’s Degree in chemical, physical or biological science or medical technology and 4+ year of industry experience
• Advanced Degree (Master’s Degree+) in Molecular Biology, Biochemistry or Genetics
• Strong scientific understanding of molecular biology and genomics
• Extensive experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq, NGS library preparation and target-enrichment
• Experience developing, implementing and supporting high complexity clinical assays
• Experience within the following regulated environments: Food and Drug Administration – Quality System Regulation, Clinical Laboratory Improvements Amendments, International Organization for Standardization and CAP, and in writing standard operating procedures, validation protocols and data reports within these environments
• Experience with Hamilton products, robotic liquid handlers, lab automation and instrumentation
• Demonstrated ability to clearly communicate scientific results in internal and external presentations and publications.
• A “results-oriented attitude”, demonstrated through a history of meeting individual and collaborative project deadlines
• Scientific thought process and understanding of assay parameters illustrating creative approaches to problem solving to inform assay troubleshooting and optimization.
• Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues
• Ability to work in the presence of chemicals and reagents
• Commitment to reflect FMI’s values: Passion, Patients, Innovation, and Collaboration
• Understanding of HIPAA and the importance of patient data privacy
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.
Internal applicants, please use your FMI email address.
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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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