Associate Director, CMC Program Lead, Cell Therapies

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Takeda Development Center Americas, Inc. is seeking an Associate Director, CMC Program Lead, Cell Therapies in Cambridge, MA with the following requirements: Master’s degree in Biotechnology, Biomedical Engineering, Bioengineering or related field plus 5 years of related experience. Prior experience must include: Utilize principles of biotechnology, engineering, and good manufacturing practices to develop, transfer, industrialize, and optimize manufacturing processes for cell and / or gene therapy products, including allogeneic therapies; Apply structured problem-solving and process improvement methodologies (DMAIC, Agile, Six Sigma, Lean, FMEA) to drive productivity and product quality improvement in Chemistry, Manufacturing & Control (CMC) processes; Employ technical project management principles (project planning, RACI, Scenario Analysis, performance indicators, strategy matrix, communication plans, Gantt charts) and analyze and interpret development data utilizing analytics software (JMP, Minitab) to drive strategic decision-making, define product strategy, and support roadmap development for product development; Lead cell and gene therapy process development including design of experiment (DoE), process optimization and control studies, unit operation automation and scale-up, technical writing including protocol development, reports, SOP authoring, batch record development and support regulatory submissions including pre-IND briefing book packages and IND filings; Represent Cell Therapy CMC teams in technical, program, and governance forums and drive program strategy and decision-making. Up to 60 percent remote work allowed.

Full time. $221,900.00 - $255,600.00 /year.

Apply on-line at www.takedajobs.com and search for Req # R0137330.