Senior Research Associate
Company: Takeda
Location: Boston
Posted on: July 13, 2025
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Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge. Job Description Pursuant to Section 20
C.F.R. 656.10, you are hereby notified that an application for
Alien Employment Certification will be filed by Takeda Development
Center Americas, Inc. for the following job opportunity: JOB
LOCATION: Cambridge, MA POSITION : Senior Research Associate
POSITION DESCRIPTION : Takeda Development Center Americas, Inc. is
seeking a Senior Research Associate with the following duties:
Manage the analytical release and stability testing of multiple
products currently under clinical development; Review, enter, and
approve all GMP testing data for analytical methods used in lot
release that are tested by a contract laboratory; Manage
relationship with external laboratory; Organize data in an internal
sample management system (PEARL) to generate trending tables that
are utilized in regulatory filings described below; Verify GMP test
data meets the established product specifications and produce
Certificates of Analysis (CoAs) for GMP batches using PEARL; Manage
analytical investigations and deviations under supervision which
may a direct impact on GMP product release and shelf life;
Represent the Analytical Controls group within Pharmaceutical
Science CMC project teams, which requires excellent organizational
and communication skills; Assist in the planning and ownership of
quality systems and may execute basic change control tasks in the
respective system; Review analytical data and contents of
analytical sections within an IND/NDA filing, that involves working
within Quality Managed Systems such as MEDIVA and VEEVA; Author
sections of regulatory dossiers for clinical trials (including
specific areas of technical expertise such as Reference Standard
management, stability design, shelf-life determination and study
conclusions, and analyses of multiple product batches to
demonstrate suitability for clinical or commercial development);
Design and oversee the execution of Drug Substance and Drug Product
stability studies. 84% remote work allowed with 5 days/month
onsite. REQUIREMENTS: Master’s degree in Regulatory Affairs,
Pharmacy, Biochemistry, Biology, or science related field plus 3
years of related experience. Prior experience must include: Conduct
regulatory sections authoring, review, and content verification for
CTD Quality modules; Perform GMP testing data review and data
integrity checks; Conduct data entry in validated systems like EDMS
(Electronic Document Management System) and provide electronic
documentation support; Use TrackWise and VEEVA to ensure accurate
tracking and compliance of records; Demonstrate interpersonal,
organizational, and communication skills to collaborate and manage
tasks. Full time. $92,000 - $153,800 per year. Competitive
compensation and benefits. Qualified applicants can apply at
https://jobs.takeda.com . Please reference job R0157405. EOE Any
individual may provide documentary evidence bearing on this
application, with information on available workers and information
on wages and working conditions, to the Certifying Officer, U.S.
Department of Labor, Employment and Training Administration, Office
of Foreign Labor Certification, 200 Constitution Avenue, NW, Room
N-5311, Washington, DC 20210. Locations Boston, MA Worker Type
Employee Worker Sub-Type Regular Time Type Full time
Keywords: Takeda, Arlington , Senior Research Associate, Science, Research & Development , Boston, Massachusetts
