Scientist - Virology
Location: Boston
Posted on: June 23, 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 Vaccines,
Inc. for the following job opportunity: JOB LOCATION: Cambridge, MA
POSITION : Scientist - Virology POSITION DESCRIPTION : Takeda
Vaccines, Inc. is seeking a Scientist – Virology with the following
duties: Collaborate with Project Managers and Contract
Manufacturing Organizations (CMO) on multiple aspects of GMP Dengue
vaccine manufacturing, specifically providing analytical testing
support/troubleshooting of cell bank and working virus seed, to
ensure safety and purity testing compliant to U.S. Food and
Administration (FDA) and European Medicines Agency (EMA)
regulations; act as project lead on development of an in-house
specialized immunoassay for Host Cell Protein (HCP); act as primary
contact and project lead for development of a novel HCP method:
Liquid Chromatography- Mass Spectrometry (LC-MS) with a Contract
Research Organization (CRO). Main responsibilities include managing
the CRO’s project timelines, providing scientific expertise when
needed, in addition to reviewing and approving CRO’s Study
protocols for Method Development, Bridging studies and
Qualification, compliant with quality and regulatory requirements;
participate in internal audit for external manufacturing sites;
provide continuing regulatory support – responses to agency
requests for information in order to gain approvals for vaccine
product; provide technical support to external laboratories and
national laboratories performing commercial testing of Takeda’s
vaccine products; involved in exploration of Next Generation
Sequencing for adventitious agents testing across different
functions; act as author and reviewer for Standard Operating
Procedures (SOPs), Analytical Risk Assessments, Product
Specifications, Laboratory Investigations, Change Controls,
Deviations, CAPA, Protocols and Reports. Less than 5% domestic and
international travel required to attend meetings or CMO/CRO sites.
Up to 20% remote work allowed. REQUIREMENTS: Master’s degree in
Cell and Molecular Biology, Plant and Animal Genetics, or related
field, plus 10 years of related experience. Prior experience must
include: increase efficiency in developing new vaccine methods or
biologic assay by leveraging training in Design of Experiment,
statistical methodologies and JMP, and stay current with vaccine
literature, virology, biochemistry, molecular biology and vaccine
development; develop and validate vaccine or biologic assays with a
focus on accuracy and reliability, ensuring compliance with
regulatory requirements, including GMP, GLP, FDA, and ISO
standards; streamline documentation and project management using
advanced skills in word processing, data presentation, and
Microsoft Project; exhibit strong oral and written communications
skills to effective reporting and collaboration within
multidisciplinary teams; and demonstrate reliability and
responsibility by prioritizing tasks and working effectively in
team to contribute positively to overall project goals. Full time.
$126,800 to $191,600 per year. Competitive compensation and
benefits. Qualified applicants can apply at https://jobs.takeda.com
. Please reference job R0149712 . 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: , Cambridge , Scientist - Virology, Science, Research & Development , Boston, Massachusetts