Senior Scientist, Molecular Biology

Solvias • Morrisville, NC

8h • Onsite

About The Position

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). 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.

Requirements

• Experienced and well versed in various molecular biology (MolBio) techniques related to Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) assays.
• Subject matter expert (SME) for molecular biology assays including qPCR, ddPCR, and NGS.
• Ability 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.
• Ability to manage multiple projects at the same time and ensure on-time testing and delivery of results to clients.
• Proficiency in analyzing/interpreting data and presenting clearly to senior/junior Solvias team members/clients.
• Ability to track assay performance/metrics, troubleshoot assays as needed, and proactively implement process improvement initiatives.
• Effective communication skills across teams, Solvias sites, and with clients.
• Ability to provide scientific expertise to projects and meeting goals.
• Experience authoring and reviewing documents required for onboarding of instrumentation, development/validation projects, raw data from operationalized assays.
• Familiarity with navigating the quality management system (QMS) at Solvias.

Responsibilities

• 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 at the same time and ensure on-time testing and delivery of results to clients.
• Exceed at analyzing/interpreting data and present clearly to senior/junior Solvias team members/clients, track assay performance/metrics, troubleshooting 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 draftly navigate the quality management system (QMS) at Solvias.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed