Associate Director, CMC Program Lead, Cell Therapies

Takeda Pharmaceutical Company • Boston, MA

435d • $221,900 - $255,600 • Remote

About The Position

The Associate Director, CMC Program Lead for Cell Therapies at Takeda Pharmaceutical is responsible for overseeing the development, transfer, industrialization, and optimization of manufacturing processes for cell and gene therapy products. This role involves applying advanced biotechnology principles and project management techniques to enhance productivity and product quality in Chemistry, Manufacturing & Control (CMC) processes.

Requirements

• Master's degree in Biotechnology, Biomedical Engineering, Bioengineering or related field.
• 5 years of related experience in biotechnology or a similar field.
• Experience in developing, transferring, and optimizing manufacturing processes for cell and/or gene therapy products.
• Knowledge of structured problem-solving and process improvement methodologies such as DMAIC, Agile, Six Sigma, Lean, and FMEA.
• Proficiency in technical project management principles and analytics software (JMP, Minitab).

Responsibilities

• Utilize principles of biotechnology, engineering, and good manufacturing practices to develop, transfer, industrialize, and optimize manufacturing processes for cell and/or gene therapy products.
• Apply structured problem-solving and process improvement methodologies (DMAIC, Agile, Six Sigma, Lean, FMEA) to drive productivity and product quality improvement in 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.
• Lead cell and gene therapy process development including design of experiment (DoE), process optimization and control studies, unit operation automation and scale-up.
• Conduct technical writing including protocol development, reports, SOP authoring, and batch record development.
• 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.

Benefits

• Competitive salary ranging from $221,900 to $255,600 per year.
• Up to 60 percent remote work allowed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Master's degree
• Number of Employees: 1,001-5,000 employees