oracle
Senior Scientist, Virology
Solvias Group
USA
Senior
USD 115000 / year
Discovered 1 months ago
Full Job Posting
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 environment.
- 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.
- Strong knowledge of regulatory compliance and quality assurance processes in CMC (Chemistry, Manufacturing, & Controls) of Cell and Gene Therapies, biologics, and vaccines
- Experience in method development, qualification & validation of CGT, biologics, vaccines, and emerging technologies.
Responsibilities
- 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.
- Supervising, coaching and mentoring junior scientists in a growing team within our multidisciplinary environment.
About Solvias Group
Pharmaceutical Manufacturing800 employeesFounded 1999
Privately held contract research organization providing cGMP analytical testing and manufacturing services to pharmaceutical and biotech companies.
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