The SR. QC Scientist will work closely with our operations group to set up QC processes and standards for gene production. In collaboration with biologists and chemists, the successful candidate will create, modify, and maintain QC protocols to monitor a complex production line. The Sr. QC Scientist will be able to learn and understand the molecular biology and next-gen sequencing behind our processes in intimate detail, in order to set up QC that monitors all aspects of the process and points clearly and quickly to sources of variation or anomaly. Good data analysis and interpersonal skills are highly valued.
What You’ll Be Doing:
●Developing, modifying, and maintaining QC protocols for molecular biology processes
●Working with R&D and Bioinformatics to define data analysis methods and metrics to track quality, with an emphasis on NGS sequencing
●Working with operations to set up and monitor the day-to-day QC work in our lab
●Working with stakeholders to set quality standards including product quality documentation, quality assurance policies, procedures protocols (SOPs)
●Preparing of product and process quality reports by collecting, analyzing, and summarizing information and trends
●Follow regulatory and ISO 13485 requirements
●M.S. or Ph.D. or equivalent experience (6+ years) in molecular biology
●Solid understanding of next-gen sequencing
●Technical knowledge of synthetic biology techniques such as PCA, DNA assembly, cloning, etc.
●Strong statistics and data analysis skills
●Excellent grasp of experimental design and data interpretation
●Strong communication and interpersonal skills
Preferred Qualifications
●Experience with DNA synthesis and/or assembly
●Industrial experience in quality (GMP, ISO, FDA)
●Deep knowledge of Tableau software
