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Associate Director, CMC Program Lead, Cell Therapies

Takeda Pharmaceutical
Posted a day ago, valid for a year
Location

Boston, MA 02203, US

Salary

$221,900 - $255,600 per annum

Contract type

Full Time

By applying, a Takeda Pharmaceutical account will be created for you. Takeda Pharmaceutical's Terms of Use and Privacy Policy will apply.

Sonic Summary

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  • Takeda Development Center Americas, Inc. is hiring an Associate Director, CMC Program Lead, Cell Therapies in Cambridge, MA.
  • Candidates must have a Master’s degree in Biotechnology, Biomedical Engineering, Bioengineering, or a related field, along with 5 years of relevant experience.
  • The role involves developing and optimizing manufacturing processes for cell and gene therapy products, utilizing methodologies like DMAIC and Six Sigma.
  • Responsibilities also include leading process development, technical writing, and supporting regulatory submissions, with up to 60 percent remote work allowed.
  • The salary range for this position is $221,900.00 - $255,600.00 per year.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time




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By applying, a Takeda Pharmaceutical account will be created for you. Takeda Pharmaceutical's Terms of Use and Privacy Policy will apply.