Senior Bioinformatician - Genetics Job at Exact Sciences (San Diego)

Job Description

The Sr. Bioinformatician plays a critical role in supporting clinical and research operations through advanced data analysis, pipeline management, and regulatory compliance. This position leads complex projects, mentors junior staff, and ensures the integrity and quality of genomic data in a regulated environment. The role requires deep technical expertise in next-generation sequencing (NGS), variant interpretation, and bioinformatics infrastructure, along with a strong understanding of regulatory frameworks and emerging trends in precision medicine.

Job Responsibility

Lead and execute complex bioinformatics analyses across multiple platforms and studies
Diagnose and resolve pipeline errors
troubleshoot QC issues and sequencing anomalies
Develop and maintain tools for variant calling, annotation, and artifact detection, incorporating new approaches and technologies
Review and interpret intermediate and final test results, ensuring analytic performance meets regulatory standards
Perform advanced case investigations for discordant results, contamination, and false positives
Coordinate data delivery for clinical studies and clinical reporting
Stay current with industry advancements, tools, and techniques
apply innovative solutions to bioinformatics challenges
Serve as Testing Personnel under CLIA and NYS regulations
Participate in verification and validation studies for new assays and workflow improvements
Assist with regulatory inspections and implement corrective and preventive actions (CAPAs)
Review and revise SOPs
ensure documentation aligns with current regulatory expectations
Evaluate proficiency testing data and contribute to regulatory submissions
Act as bioinformatics lead on cross-functional projects involving R&D, clinical, and laboratory stakeholders
Mentor and train junior bioinformatics staff
sign off on training and competencies
Present complex findings and strategic recommendations to laboratory management and executive stakeholders
Foster consensus and collaboration across teams, leveraging a strong understanding of how bioinformatics integrates with assay development, data science, and IT infrastructure

Requirements

PhD in bioinformatics, computational biology, computer science, or field as outlined in the essential duties
or Master’s degree plus 4 years of experience in lieu of a PhD
or Bachelor’s degree plus 6 years of experience in lieu of a PhD
5+ years of experience in bioinformatics and/or bioinformatics operations in industry or academia
3+ years in a regulated environment (e.g., medical device, IVD, biotech, or pharma)
Proficiency in Linux-based HPC or cloud computing environments
Proficiency writing custom code with the ability to adapt to commonly used languages
Expertise in NGS and genomics
Experience with statistical software (e.g., R, JMP)
Strong documentation, communication, and problem-solving skills
Demonstrated ability to perform the essential duties of the position with or without accommodation
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis

Nice to have

8+ years of experience in regulated bioinformatics roles
Experience in a regulated product development and submissions
Familiarity with public human genome variation databases
Experience with variant artifact classification and LIMS systems
Prior leadership or project management experience
Demonstrated understanding of the competitive landscape in bioinformatics or clinical genomics

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility

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Senior Bioinformatician - Genetics

Job Description

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Requirements

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