Associate Director/Director, Downstream Process Development KBI Biopharma
THIS JOB HAS EXPIRED The Associate Director/Director will manage a team of scientists in the downstream process development team to ensure seamless execution of all projects. Activities in the downstream process development area range from the development of downstream processes to enable the progression of biological entities into clinical trials, technology transfer to manufacturing, production of toxicology material, process characterization/design space studies in support of late-stage programs and the development of novel downstream process technologies. Knowledge of the latest developments in the downstream process area and experience in the development of robust processes for clinical & commercial stage programs is essential. Ability to work and collaborate effectively with allied functional areas is critical.
?Directs the activities of the Downstream process development group, developing purification processes for recombinant proteins for transfer to manufacturing.
?Plans and utilizes resources to meet development and production schedules.
?Identifies project delay issues and implements appropriate actions to keep projects on track.
?Ensures that the Downstream group works within budgets and meets project timelines.
?Mentors and develops a staff of scientists to execute all activities in the downstream process development area.
?Works with Business Development and area management in developing project scopes and budgets.
?Prepare annual expense and capital budgets for the Downstream Development group.
?Projects new equipment requirements for development and production.
?Maintains liaison with other functional areas to ensure timelines and company milestones are met.
?PhD in Biochemistry/Biochemical Engineering.
?8+ years of related experience and/or training with significant managerial experience.
?Must have knowledge of cGMPs and biotechnology-derived product regulations.
||Durham, NC |
THIS JOB HAS EXPIRED