Associate Director, Cmc Program Lead, Cell Therapies

Details of the offer

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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeBy applying, you consent to your information being transmitted by GrabJobs to the Employer, as data controller, through the Employer's data processor SonicJobs.
See Takeda Pharmaceutical Terms of Use at https://www.takeda.com/terms-of-use/ and Privacy Policy at https://www.takeda.com/privacy-notice/ and SonicJobs Privacy Policy at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at https://www.sonicjobs.com/us/terms-conditions


Nominal Salary: To be agreed

Source: Grabsjobs_Co

Job Function:

Requirements

Licensed Psychologist

Thriveworks is currently seeking Licensed Clinicians to provide a mix of telehealth and face-to-face sessions in Newton, MA. ***For a limited time, we are of...


Thriveworks - Massachusetts

Published 8 days ago

Licensed Psychologist

Thriveworks is currently seeking Licensed Clinicians to provide a mix of telehealth and face-to-face sessions in Newton, MA. ***For a limited time, we are of...


Thriveworks - Massachusetts

Published 8 days ago

Clinical Social Worker

Thriveworks is currently seeking Licensed Clinicians to provide a mix of telehealth and face-to-face sessions in Framingham, MA.***For a limited time, we are...


Thriveworks - Massachusetts

Published 8 days ago

Clinical Social Worker

Thriveworks is currently seeking Licensed Clinicians to provide a mix of telehealth and face-to-face sessions in Framingham, MA.***For a limited time, we are...


Thriveworks - Massachusetts

Published 8 days ago

Built at: 2024-12-23T16:34:06.632Z