Scientist, Molecular Biology

Solvias • Morrisville, NC

10h • Onsite

About The Position

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). 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

• Experience and well versed in various molecular biology (MolBio) techniques related to Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) assays.
• Good Manufacturing Practices (GMP) knowledge.
• Ability to manage multiple tasks and ensure on-time testing and delivery of high-quality results.
• Troubleshooting skills.
• Effective communication skills.

Nice To Haves

• Experience in assay development, validation, and transfer of analytical methods for cell & gene therapy products.

Responsibilities

• Consistently & reliably document client and control samples through nucleic acid isolation, PCR, & NGS assays with minimal supervision.
• 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.

What This Job Offers

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