Perform process analytics and product release testing on therapeutic lentiviral vector products. Requires training and practical experience characterizing the physical and molecular attributes of lentiviral vectors using ELISA, qPCR, Westerns, microfluidics, HPLC, particle sizing and other appropriate assays. Direct experience with biological testing of vectors for their ability to transduce target cells using flow cytometry and other relevant methods preffered. Work collaboratively to develop and perform automated and high throughput analytical screening methods,and lentiviral vector formulation and stability studies. Lead efforts to define the most relevant viral vector product quality attributes and design efficient and validatable assays to measure these parameters. Provide written contribution to regulatory agency briefing books and to other development reports. Work collaboratively with internal colleagues and external partners to improve and transfer assay methods to CMOs and to internal Novartis manufacturing sires. Fully trained in viral vector manufacturing and analytics technologies. Observe relevant BSL2 safety policies governing work with lentivirus vectors.
M.S. or B.S. with at least 3 years' experience in lentiviral vector analytical methods. English. Have excellent assay documentation training and thorough practical awareness of viral vector purification and GMP compliance principles. Have excellent communication and project management skills to facilitate interactions with internal colleagues and with external collaborators and partners. Ability to Analyze other viral and non-viral format vectors. Excellent attention to detail.