Scientist Job Alert at Foundation Medicine | Apply Now
Looking for a Scientist Job in the life sciences field? Here’s an exciting opportunity with Foundation Medicine, a global leader in precision oncology. This role offers hands-on experience in Next Generation Sequencing (NGS), assay development, and validation within a regulated environment. If you’re exploring Foundation Medicine careers or seeking life science jobs in US, this position could be your next big step.
Job Details
- Job Position: Scientist I, Diagnostic Development & Validation
- Location: 400 Summer Street, Boston, Massachusetts, United States
- Job Type: Full Time
About the Company
Foundation Medicine is a global, patient-focused precision medicine company delivering high-quality, transformative diagnostic solutions in cancer and other diseases. As part of growing Foundation Medicine careers, the organization focuses on innovation, collaboration, and improving patient outcomes through advanced genomic profiling. It is one of the leading names offering impactful life science jobs in US.
Job Description
This Scientist Job role supports the full product development lifecycle, from concept through commercial launch, of new Next Generation Sequencing (NGS)-based assays under 21 CFR part 820 Quality System Regulations (QSR) Design Control. This scientist job contributes to laboratory and documentation activities in collaboration with a cross-functional team to verify and validate product requirements, assay design, and assay performance.
The role also performs validation test planning as well as hands-on execution in the laboratory. Regular onsite work at a designated FMI location is an essential function of this position, making it a strong opportunity within Foundation Medicine careers and among top life science jobs in US.
Qualifications
This Scientist Job Role requires:
Basic
- Bachelor’s Degree in a life science
- 2+ years of directly related industry experience
Preferred
- Ability to work in a laboratory environment with chemicals and reagents
- PhD in Molecular Biology, Biochemistry, Genetics, or Cancer Genetics
- Clinical Laboratory Science or Clinical Molecular Biology license
- Experience with molecular biology techniques and NGS (DNA-seq, target-enrichment)
- Experience developing genomic assays in regulated environments
- Experience with robotic liquid handlers, lab automation, and instrumentation
- Experience with FDA-QSR, CLIA, CAP, and ISO regulations
- Experience writing SOPs, validation protocols, and reports
- Strong project management and multitasking skills
- Ability to work in fast-paced team environments
- Strong collaboration and problem-solving skills
- Understanding of HIPAA and patient data privacy
- Excellent organizational skills and attention to detail
Salary & Benefits
The expected salary range for this scientist job in Boston, MA is $95,000 – $115,000 per year. Compensation is based on education, experience, and market conditions. A discretionary annual bonus and comprehensive benefits are also included, making it a competitive offering among life science jobs in US.
Key Responsibilities
This Scientist Job Role responsibilities include:
- Prepare and handle biological specimens including blood, plasma, formalin-fixed paraffin-embedded samples, and extracted nucleic acids.
- Execute development, verification, and validation studies for novel diagnostic NGS assays.
- Process and manage samples using automated workflows and Laboratory Information Management System (LIMS).
- Lead training and performance qualification testing during technology transfer between product development and laboratory operations teams.
- Author Performance Qualification (PQ) and Process Performance Qualification (PPQ) study protocols.
- Author detailed records of experimental data, present results, and prepare reports for submission to regulatory agencies (FDA).
- Analyze and compile data for study reports.
- Prepare and organize study reagents.
- Document design control documentation, CDx assay requirements, functional specifications, and study results in a QSR-compliant manner.
- Collaborate with Quality Assurance and Regulatory teams to meet audit and accreditation standards.
- Establish and validate performance parameters, quality control, and stability specifications for critical reagents.
- Support processing and reporting of oncology samples.
- Conduct investigations to troubleshoot and improve assay capabilities.
- Perform other duties as assigned.
