Lead a team associated with the design, construction/synthesis, cloning, production, and evaluation of investigational lentiviral vectors for pre-clinical activities, as well as the generation of processes and procedures for vector production and purification including process design, process improvement, scale-up, technology transfer and troubleshooting.The Manager will have outstanding technical skills in molecular biology and the scientific aspects of lentiviral vector production, including an understanding of, and compliance to, GxP, with an excellent understanding of scientific concepts. AAV vector experience is also highly desired.
· LeadsR&D activities associated with viral vector generation and production.
· Develops and refines scientific strategy for viral vector production.
· Ensures production of lentiviral vectors to support pre-clinical activities including, but not limited to; lead candidate screening, selection and optimization, in vitro and in vivo efficacy studies, in vitro and in vivo mechanism of action or proof of concept studies, early stage pharmacology and toxicology studies, and assay development activities.
· Provides early-stage characterization of viral vectors.
· Interprets data/results to refine processor applies new technologies as appropriate to optimize vector potency or manufacturing process to increase yield, efficacy and safety.
· Directs multiple projects and troubleshoots unexpected problems.
· Ensures relevant lab space is fitted with state-of-the-art equipment; ensures relevant lab equipment is qualified, validated and appropriately documented; ensures team is trained and appropriately following all processes and procedures, ensuring the highest quality vector preparations.
· Reviews relevant literature and emerging data to remain current and cutting edge within gene therapy field.
· Contributes to regulatory submissions.
· Inspires, builds, and develops a team, creating an atmosphere of collaboration, communication and shared learning.
· Defines capital needs (e.g., maintenance of existing and/or design and build-out of new lab space, FTE/resource needs, budget forecasts and budget management for team activities.
· Bachelor’s degree (e.g., A.B., B.A,B.S.) or equivalent in Biotechnology, Molecular Biology, Virology, BiochemicalEngineering or related discipline with substantial experience in gene therapy and viral vectors; MS, PhD or equivalent strongly preferred.
· At least 5 years of experience working with lentiviral vectors; experience with AAV vectors also valued.
· Experience designing, constructing, and producing recombinant viral vectors; experience with the iCELLis platform for vector production preferred.
· Experience producing viral vectors by transient transfection as well as from stable producer cell lines.
· Broad perspective of the overall gene therapy field.
· Experience with regulatory requirements for viral vectors.
· Strong leadership skills; able to inspire a group of scientists.
· At least 3 years people management/leadership experience.
· Strong team player with the ability to work cross-functionally and collaboratively.
· Strong planning, management, and excellent organizational skills with an ability to multi-task and manage others to do the same.
· Ability to respond to and manage change.