Qc Scientist - Next Generation Sequencing

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.

Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

Job Summary

The QC NGS (Next Generation Sequencing) Scientist will be responsible for the development, validation, and performance of NGS methodologies, including library preparation, data analysis and reporting in support of batch release and Environmental Monitoring (EM). The QC NGS Scientist serves as the NGS Subject Matter Expertise (SME) to provide insight and perform NGS studies in support of other functions within the company.

Job Responsibilities

• Perform validation of the developed procedures, including defining CQA and ATP for each procedure, drafting validation protocol and SOP, performing validation testing and analysis against pre-defined acceptance criteria, authoring validation report
• Create, revise, and finalize standard operating procedures (SOP), product specifications, and other GMP documents
• Provide training to Analysts for newly developed methods
• Contribute to Quality Event reports for Out of Specification (OOS) investigations or other laboratory investigations including Root Cause determination and Corrective Actions and Preventative Actions (CAPA), as needed
• Support other groups or as designated by Management team by providing insights and performing investigatory studies
• Identify new techniques and instrumentation to expand internal capabilities. Prepare justification for new lab equipment.
• Perform NGS testing, including library preparation, data analysis, result reporting
• Prepare purchase orders and coordinate authorization, procurement, and implementation
• Manage the lifecycle of each procedure by monitoring performance characteristics
• Develop library preparation methodologies and bioinformatic pipelines for small genome sequencing on MiSeq for various purposes, e.g. provide data and insight on selecting the most appropriate library prep kits for different purposes, optimize library prep procedure, troubleshooting instrument issues, work with IT on data management, provide data and insight on selecting the most appropriate computing algorithms at each step of the bioinformatic pipeline, establish checkpoint to ensure NGS library quality and bioinformatic pipeline suitability, formulate the NGS report templates

Qualifications

• 4+ years of experience working with Illumina NGS platforms; Experience in assay development, optimization, experimental design, and data analysis, preferably in a GMP or clinical environment
• Ability to work on cross functional teams; Must be able to develop solutions for simple and complex problems, which require a high degree of ingenuity, creativity, and innovation; demonstrate high ethical standards, trustworthiness with strong communication and leadership skills
• Strong background in NGS methodologies; Knowledge of regulatory documents including ICH, USP, EP, and FDA guidance documents is preferred; Familiarity with data collection and management software such as electronic laboratory notebooks (ELN) and LIMS is a plus
• M.S. in molecular biology, biochemistry, or microbiology or related field is required. Education in computational biology or bioinformatics is preferred.

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When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.