Analyst, Molecular Biology

Solvias•Morrisville, NC

5h•Onsite

About The Position

Located at our large molecule headquarters in RTP, North Carolina, the Analyst, Molecular Biology will be experienced in basic laboratory techniques, aseptic handling of reagents and samples, and is required to have a general understanding of molecular biology (MolBio) processes, such as, but not limited to, Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS). This position is on-site based at the newly built North America Center of Excellence in RTP, North Carolina and part of the Large Molecule & Advanced Therapy Medicinal Products Services laboratory adhering to Good Manufacturing Practices (GMP) standards. 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 in basic laboratory techniques
Aseptic handling of reagents and samples
General understanding of molecular biology (MolBio) processes, such as, but not limited to, Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS).
Adhering to Good Manufacturing Practices (GMP) standards.

Responsibilities

Perform quality lab activities according to assigned schedule.
Process samples for release and stability testing of drug product/drug substances as part of the Operations routine testing team, including complex sample preparation and in compliance with GMP requirements.
Document experiments, sample tracking, and raw data according to Standard Operating Procedures (SOPs) and GMP standards.
Support development and validation of PCR & NGS assays.
Generate raw data, perform data analysis, and interpret data for assays as needed.
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.
Generate data, record assay metrics, and proactively implement performance improvements.
Communicate effectively with the MolBio leadership with regard to project status, issues encountered, and/or other technical challenges/successes.
Communicate effectively with the MolBio leadership, and across various teams at RTP.