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Position Overview
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.
The Sr. Bioinformatician brings innovative thinking to problem-solving, a cross-disciplinary mindset, and awareness of industry best practices and competitive landscapes in bioinformatics.
This position will be onsite in San Diego.
Essential Duties
Include, but are not limited to, the following:
- 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.
- Ability to work independently and collaboratively in a fast-paced, regulated environment.
- Strong attention to detail and commitment to data integrity.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Maintain regular and reliable attendance.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to travel up to 5% of working time away from work location, may include overnight/weekend travel.
Minimum Qualifications
- 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. We are unable to sponsor or take over sponsorship of employment visas at this time.
Preferred Qualifications
- 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.
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Salary Range:
$119,000 - $178,000
The annual base salary shown is for this position located in US - CA - San Diego on a full-time basis. In addition, this position is bonus eligible.
Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.
Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.
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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.
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