Person, Animal, Mammal, Canine, Pet, Text

Scientist I

Full Time | Cambridge | Massachusetts | United States

About the Job

The Scientist I, Companion Diagnostics (CDx) 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. The position 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 position also performs validation test planning as well as hands-on execution in the laboratory. 

Key Responsibilities

• 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 the product development and laboratory operations teams.

• Author Performance Qualification (PQ) and Process Performance Qualification (PPQ) study protocols.

• Author detailed, accurate, and accessible records of experimental data, present results at group meetings, to external collaborators, and preparation of reports for submission to regulatory agencies (FDA).

• Analyze and compile data for preparation of study reports and generate study reports.

• Prepare and organize study reagents.

• Prepare and document design control documentation, CDx assay requirements, functional specifications, performance and study results, and other data in a QSR-compliant manner.

• Partner collaboratively with the Quality Assurance and Regulatory teams to ensure that all procedural and submission documentation meets audit and accreditation standards.

• Establish and validate performance parameters, quality control, and stability specifications for critical reagents.

• Support the timely processing and reporting of oncology samples to internal and external collaborators.

• Conduct investigations and analyses to troubleshoot and improving assay capabilities, enhance technical robustness and existing methods.

• Other duties as assigned.


Basic Qualifications

• Bachelor’s Degree in a life science and 5+ years of directly related industry experience

• Alternatively, Master’s Degree in a life science plus 2+ years of directly related industry experience

Preferred Qualifications

• Ability to work in a laboratory environment where chemicals and regents are present

• PhD in Molecular Biology, Biochemistry, Genetics or Cancer Genetics

• Current California Clinical Laboratory Science or Clinical Molecular Biology license

• Experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq and target-enrichment

• Experience in the development and/or implementation of genomic assays in a regulated environment including writing standard operating procedures, validation protocols and reports

• Experience with robotic liquid handlers, lab automation and instrumentation (especially Hamilton)

• Experience developing, implementing and supporting high complexity clinical assays in a regulated environment (such as with Food and Drug Administration-QSR, Clinical Laboratory Improvement Amendments, College of American Pathologists, and International Organization for Standardization regulations)

• Experience writing standard operating procedures (SOPs) validation protocols and data reports

• Track record of successfully managing multiple concurrent initiatives and maintaining one’s own workflow with timely completion ahead of deadlines

• Demonstrated ability to work in a dynamic, fast paced team environment

• Strong cross-functional collaboration and problem solving skills

• Understanding of HIPAA and the importance of privacy of patient data

• Ability to work well under pressure while maintaining a professional demeanor

• Excellent organizational skills and attention to detail

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Internal applicants, please use your FMI email address.

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