Senior Scientist, Molecular Biology

Senior Scientist, Molecular Biology Located at our large molecule headquarters in RTP, North Carolina, the Senior 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). Position Overview On-site based within a GMP‑compliant laboratory environment, the role focuses on leveraging advanced molecular biology techniques for the development, validation, and transfer of analytical methods to support CGT drug substance and product testing. Critical Performance Areas Supervise, participate in lab activities, and act as the subject matter expert (SME) for molecular biology assays including qPCR, ddPCR, and NGS. Coordinate with the Team Lead to train, develop, and coordinate daily laboratory tasks for the team. Function as a scientific lead to develop, validate, and transfer analytical methods for the analysis of CGT drug substance/drug products using PCR and NGS assays according to GMP requirements. Manage multiple projects simultaneously and ensure on‑time testing and delivery of results to clients. Analyze, interpret data, and present findings clearly to senior/junior Solvias team members and clients; track assay performance/metrics, troubleshoot assays as needed, and proactively implement process improvement initiatives. Communicate effectively across teams, Solvias sites, and with clients, providing scientific expertise to projects and meeting goals. Author and review documents required for onboarding of instrumentation, development/validation projects, raw data from operationalized assays, and navigate the quality management system (QMS) at Solvias. Responsibilities Ensure compliance with GMP regulatory requirements and SOPs. Review and approve data in digital or paper-based lab notebooks, draft & review protocols, validate analysis tools/formulas, and ensure accuracy of internal and external reports. Investigate under GMP regulatory guidelines for deviation, non‑conformity, OOS, change controls, and other quality events. Train scientists and analysts on the team as needed, coach team members for scientific and professional development, and manage a subset of direct reports. Contribute to process improvements for effective and efficient operational workflows in the lab. Oversee inventory maintenance, ordering of laboratory supplies, and instrument maintenance. Work collaboratively with cross‑functional teams at Solvias and clients on projects/initiatives. Be able to multitask and adjust prioritization as necessary. Requirements M.S. or Ph.D. in Life Sciences with 5+ years relevant experience or B.S. with 10+ years relevant experience. Experience working on NGS, qPCR, ddPCR, genomic library preparation, and nucleotide extraction in a GMP, GLP, or GCP environment. Experience in method development, qualification & validation of qPCR, ddPCR, NGS assays, and emerging technologies. Client‑facing experience for assay development and operational processing updates is expected. Other Desired Skills/Abilities Excellent organizational skills, constant attention to detail, ability to work independently and collaboratively in a team environment. Strong written and verbal communication skills. Experience working with LIMS, automation, databases, statistics/programming, and building/presenting slide decks for client‑facing presentations. Lean 6Sigma. Reporting Structure Team Lead, Molecular Biology Additional Information 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. A presentation by the candidate is expected if the candidate passes the screening stage. 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. About Us: Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end‑to‑end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards. #J-18808-Ljbffr Solvias