Senior Scientist, Virology

Job Description

Join our dynamic team as a Senior Scientist Virologist, working in a fast-paced department delivering safety testing to the pharmaceutical industry during the manufacture and testing of cell and gene therapies, biologics and vaccines in a fast-moving GMP environment, and serving manufacturers of pharmaceuticals worldwide.

The candidate will have expertise in key virology skills, including viral culture techniques, virus identification, virus-host interaction analysis, and be familiar with the principles of detection of adventitious viruses in biological materials. Such as, unprocessed bulk harvest, biological raw materials, and drug substance and drug product testing. Familiarity with viruses across the range of human and veterinary viral pathogens, including typical growth characteristics and detectability with the standard endpoints of cytopathic effect, hemadsorption, and hemagglutination. The candidate should be able to demonstrate seniority in knowledge of cellular virology and be conversant with the characteristics of the major virus families and their effects in cell culture. The ability to speak on this subject with clients at varying levels of seniority will be a plus.

Proficiency in viral and cell culture maintenance and quantification methods is essential. Additionally, experience with vector design, cell line development, and gene editing technologies will be critical in optimizing therapeutic applications.

The applicant must have strong knowledge of regulatory compliance and quality assurance processes in CMC (Chemistry, Manufacturing, & Controls) of Cell and Gene Therapies, biologics, and vaccines to ensure adherence to regulatory compliance and meet industry GMP standards.

Your leadership and collaboration skills will be vital in guiding operational activities, while also coaching and mentoring junior scientists in a growing team within our multidisciplinary environment.

• Day to day performance and supervision of viral detection assays as per EP 5.2.3 and EP 2.6.16.
• Supervision of lab technicians and scientists in the execution of diverse virology assays including assays for adventitious viruses and vector quantitation assays with endpoints such as flow cytometry and Elisa.
• Tracking, trending, and monitoring of assay performance metrics and maintenance over time, in compliance with Solvias’ Quality Management System/improvement initiatives.
• As the SME, you will be consulting with clients on specific attributes of samples, processing, and troubleshooting prior/during testing of biological matrices to ensure optimal testing strategies for product types.
• Day to day liaison with the commercial and project management teams to ensure appropriate inputs for costing and quoting of work and flawless execution of work, along with suitably prioritized timelines and deliverables for departmental projects and revenue streams. The ability to work with cross-disciplinary teams across the sites in the Solvias organization is a must, and communication and presentation skills should be excellent.
• Maintenance and curation of key reagents including virus stocks and cell banks with periodic renewal and implementation of new stocks / reagents for an expanding portfolio.

Requirements

• M.S. or Ph.D. Life Sciences with 5+ years relevant experience or B.A/B.S. with 10+ years relevant experience.
• Experience working on viral & cell culture, vector design, cell line development, and gene editing technologies in a GMP, GLP, or GCP
• Experience in method development, qualification & validation of CGT, biologics, vaccines, and emerging technologies.

Reporting Structure

• Team Lead, Molecular Biology & Virology

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.

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.

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