Senior Analyst, Virology at Solvias

Morrisville, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Sep, 26

Salary

0.0

Posted On

24 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Viral Culture Maintenance, Viral Quantification, Infectious Titer, rcAAV, RCL, Viral Characterization, Vector Design, Cell Line Development, Gene Editing, GMP Compliance, GLP Compliance, Molecular Biology Assays, LIMS, Lean 6Sigma, Data Analysis, Sample Preparation

Industry

Pharmaceutical Manufacturing

Description

Located at our US headquarters in RTP, North Carolina, the Senior Analyst, Virology position will be experienced in basic laboratory techniques related to viral and cell culture maintenance and viral quantification methods. This role will support the execution and analysis of virology and molecular biology assays, with a strong emphasis on Infectious titer, rcAAV, RCL, and viral characterization, in a highly regulated environment. Additionally, experience with vector design, cell line development, and gene editing technologies are desirable skills. The successful candidate will perform assay execution and support development and validation activities for client programs in gene therapy, vaccines, and biologics, while ensuring compliance with GMP/GLP regulations and data integrity standards. This position is on-site based in the newly built US headquarters in RTP. The position is part of the Large Molecule & Advanced Therapy Medicinal Products Services laboratory environment and follows Good Manufacturing Practices (GMP). Critical Performance Areas * 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 efforts. * 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 Virology leadership with regard to project status, issues encountered, and/or other technical challenges/successes. * Communicate effectively with the Virology leadership, and across various teams at RTP. 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

Responsibilities

Execute and analyze virology and molecular biology assays, focusing on viral characterization and titer in a GMP/GLP environment. Support development and validation activities for gene therapy, vaccines, and biologics programs while ensuring data integrity.