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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 Privacy 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

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