Associate Director, CMC Program Lead, Cell Therapies
Company: Takeda Pharmaceutical
Location: Boston
Posted on: October 29, 2024
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Job Description:
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's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionTakeda 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
and search for Req # R0137330.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Lynn , Associate Director, CMC Program Lead, Cell Therapies, Executive , Boston, Massachusetts
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