Scientist II, Bioinformatics QC

Duties and Responsibilities

• Execute bioinformatics QC analyses across multi-omics assays (e.g., RNA-seq, WGS, structural variation, epigenetic profiling) to support product quality assessment and release
• Analyze and interpret data against established acceptance criteria; escalate atypical results and support investigation activities
• Prepare and maintain compliant documentation supporting QC review, deviation investigations, and audit readiness
• Support root cause analysis and re-analysis workflows for QC deviations and process excursions
• Maintain traceability of data, methods, and outputs in alignment with GMP and data integrity expectations
• Collaborate with QC, QA, Manufacturing, and R&D teams to support sample processing timelines and data delivery
• Contribute to process improvements, workflow optimization, and automation initiatives for bioinformatics QC
• Aid in the development and evaluation of new analytical methods to support characterization of product lots and intermediates
• Support qualification and validation activities for bioinformatics pipelines and systems

Education and Experience

• PhD in Bioinformatics, Genomics, Computational Biology, or related field (or equivalent combination of education and relevant experience)
• Hands-on experience with NGS data analysis pipelines (RNA-seq, WGS, or similar)
• 3 or more years of experience working in the life sciences industry or other regulated environments (GMP/GxP), including understanding of data integrity expectations

Job Specifications

• Genomics Expertise: Strong understanding of human genetics and genomics, including variant analysis, gene expression, and structural variation in applied settings
• Programming: Proficiency in scripting and data analysis tools (e.g., Python, R, Bash) to support reproducible workflows
• Data Quality: Excellent attention to detail with demonstrated ability to produce accurate, high-quality, and traceable datasets
• QC/QA Processes: Familiarity with QC and QA workflows, documentation practices, and audit readiness requirements
• Biological Interpretation: Ability to interpret biological and genomics data in clinical or translational contexts to support QC decision-making
• Communication: Strong written and verbal communication skills, with the ability to clearly document and explain analytical methods and results
• Scientific Judgment: Comfort working with ambiguity and applying scientific reasoning to analyze and troubleshoot real-world datasets
• Validation & Systems: Exposure to qualification and validation of bioinformatics systems and pipelines in regulated environments
• Workflow Design: Ability to contribute to the design, improvement, and scaling of bioinformatics workflows and organizational systems

Working Conditions

• Office and Lab environment
• Frequent exposure to toxic or caustic chemicals
• Ability to perform experiments in the laboratory, and type and use a computer
• No Cleanroom access needed

Physical Demands

• Regularly stand, walk, sit, use hands to finger, handle, or feel, reach with hands and arms, talk or hear
• Occasionally lift and/or move up to 10 pounds
• Close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus

Total Rewards and Culture

• Competitive total compensation package
• Time-off in addition to Company observed holidays
• Medical/Dental insurance benefits
• Onsite gym
• Other wellness perks