Scientist, Molecular Biology

Position Overview Located at our large molecule headquarters in RTP, North Carolina, the Scientist, Molecular Biology will be experienced and well versed in various molecular biology (MolBio) techniques related to Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) assays. This position is on-site based and is part of the Large Molecule & Advanced Therapy Medicinal Products Services laboratory environment following Good Manufacturing Practices (GMP). Critical Performance Areas Consistently & reliably document client and control samples through nucleic acid isolation, PCR, & NGS assays with minimal supervision. In addition to performing above, conduct quality lab activities to maintain optimal laboratory function/performance in a highly regulated environment. Coordinate with the Senior Scientist &/or Team Lead to execute daily laboratory tasks, such as processing client samples, assay development project design and testing, as well as training activities. Assist in the development, validation, and transfer of analytical methods for the analysis of cell & gene therapy products according to GMP requirements. Perform routine testing of client samples across various phase appropriate validated GMP assays. Manage multiple tasks at the same time and ensure on-time testing and delivery of the highest quality results. Generate data, record assay metrics, provide troubleshooting support, and proactively implement performance improvements. Communicate effectively with the MolBio leadership, and across various teams at RTP. Essential Job Functions Ensure compliance with GMP regulatory requirements and SOPs. Process client samples, qualify controls/standards, document all processes in Laboratory Information Management Systems/Electronic Lab Notebooks (LIMS/ELN), review draft protocols, and other aspects of a laboratory operations regulated environment. Participate in investigations of processing Quality Events (QE): deviations, non-conformity, OOS, change controls, and other QEs as they occur. Train peers and analysts in the team as needed. Requirements . Life Sciences with 3+ years, . with 5+ years, or /. with 7+ years relevant experience. Experience working on NGS, qPCR, ddPCR, genomic library preparation, and nucleotide extraction in a GMP, GLP, or GCP environment. Experience working in a regulated operational & development environment involved in validation of qPCR, ddPCR, NGS assays, and other emerging technologies. Other Desired Skills/Abilities Previous CRO experience. Excellent organizational skills along with the ability to work both independently and collaboratively in a team environment. Strong written and verbal communication skills. Experience working with spreadsheets, LIMS, ELNs, laboratory automation, databases, statistics/programming, and building slide decks for client presentation. Lean 6Sigma training. Able to multitask and adjust prioritization as necessary. Bioinformatics experience is desirable, but not a requirement. Reporting Structure This job typically reports to: Team Lead: Molecular Biology. NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization. Disclaimer: Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting. #J-18808-Ljbffr solvias