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
Requirements
- Bachelor’s or Master’s degree in Virology, Microbiology, Molecular Biology, or related field with 3+ years of experience.
- Hands-on experience working on viral & cell culture, vector design, cell line development, and gene editing technologies in a GMP, GLP, or GCP environment.
Prior CRO/CDMO experience is strongly preferred .
-
Other Desired Skills/Abilities
- Excellent organizational skills, 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 slide decks for client presentation.
- Lean 6Sigma.
Able to multitask and adjust prioritization as necessary.
-
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.
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.
Requirements
- Bachelor’s or Master’s degree in Virology, Microbiology, Molecular Biology, or related field with 3+ years of experience.
- Hands-on experience working on viral & cell culture, vector design, cell line development, and gene editing technologies in a GMP, GLP, or GCP environment.
Prior CRO/CDMO experience is strongly preferred .
-
Other Desired Skills/Abilities
- Excellent organizational skills, 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 slide decks for client presentation.
- Lean 6Sigma.
Able to multitask and adjust prioritization as necessary.
-
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.
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.
Essential Job Functions
- Independently execute virology assays including TCID50, rcAAV, infectivity, and neutralization assays
- Perform mammalian cell culture, viral propagation, and sample processing
- Conduct qPCR and ddPCR for viral quantification and detection
- Ensure compliance with GMP regulatory requirements and SOPs.
- Process client samples, qualify controls/standards, document all processes in Laboratory Information Management Systems/Electronic Lab Notebooks (LIMS/ELN), review draft protocols, and other aspects of a laboratory operations regulated environment.
- Participate in investigations of processing Quality Events (QE): deviations, non-conformity, OOS, change controls, and other QEs as they occur.
- Contribute to process improvements for effective and efficient workflows in the lab.
- Maintain inventory, order laboratory supplies, organize instrument maintenance, etc.
- Work collaboratively with cross-functional teams.
Essential Job Functions
- Independently execute virology assays including TCID50, rcAAV, infectivity, and neutralization assays
- Perform mammalian cell culture, viral propagation, and sample processing
- Conduct qPCR and ddPCR for viral quantification and detection
- Ensure compliance with GMP regulatory requirements and SOPs.
- Process client samples, qualify controls/standards, document all processes in Laboratory Information Management Systems/Electronic Lab Notebooks (LIMS/ELN), review draft protocols, and other aspects of a laboratory operations regulated environment.
- Participate in investigations of processing Quality Events (QE): deviations, non-conformity, OOS, change controls, and other QEs as they occur.
- Contribute to process improvements for effective and efficient workflows in the lab.
- Maintain inventory, order laboratory supplies, organize instrument maintenance, etc.
- Work collaboratively with cross-functional teams.
