Senior Director, Cell Therapy Process Development
3 weeks ago
We are seeking a highly skilled Associate Director, CMC Program Lead, Cell Therapies to join our team at Takeda Development Center Americas, Inc. in Cambridge, MA.
The ideal candidate will have a Master's degree in Biotechnology, Biomedical Engineering, Bioengineering or a related field, plus 5 years of related experience.
Prior experience must include:
- Utilizing 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.
- Applying 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.
- Employing technical project management principles (project planning, RACI, Scenario Analysis, performance indicators, strategy matrix, communication plans, Gantt charts) and analyzing and interpreting development data utilizing analytics software (JMP, Minitab) to drive strategic decision-making, define product strategy, and support roadmap development for product development.
- Leading cell and gene therapy process development, including design of experiment (DoE), process optimization and control studies, unit operation automation and scale-up, technical writing, and support regulatory submissions.
This is a full-time position with up to 60% remote work allowed. The salary is $221,255,600 per year.
Apply online at [insert link] and search for Req # [insert Req #].
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