Scientist – Virology Position Available In Suffolk, Massachusetts

Job Description:

By clicking the “Apply” button, I understand that my employmentapplication process with Takeda will commence and that theinformation I provide in my application will be processed in linewith Takeda’s Privacy Notice and Terms of Use . I further attestthat all information I submit in my employment application is trueto the best of my knowledge. Job Description Pursuant to Section 20C.F.R. 656.10, you are hereby notified that an application forAlien Employment Certification will be filed by Takeda Vaccines,Inc.

for the following job opportunity:

JOB LOCATION

Cambridge, MAPOSITION :

Scientist – Virology

POSITION DESCRIPTION

: TakedaVaccines, Inc. is seeking a Scientist – Virology with the followingduties: Collaborate with Project Managers and ContractManufacturing Organizations (CMO) on multiple aspects of GMP Denguevaccine manufacturing, specifically providing analytical testingsupport/troubleshooting of cell bank and working virus seed, toensure safety and purity testing compliant to U.S. Food andAdministration (FDA) and European Medicines Agency (EMA)regulations; act as project lead on development of an in-housespecialized immunoassay for Host Cell Protein (HCP); act as primarycontact and project lead for development of a novel HCP method:

Liquid Chromatography- Mass Spectrometry (LC-MS) with a ContractResearch Organization (CRO). Main responsibilities include managingthe CRO’s project timelines, providing scientific expertise whenneeded, in addition to reviewing and approving CRO’s Studyprotocols for Method Development, Bridging studies andQualification, compliant with quality and regulatory requirements;participate in internal audit for external manufacturing sites;provide continuing regulatory support – responses to agencyrequests for information in order to gain approvals for vaccineproduct; provide technical support to external laboratories andnational laboratories performing commercial testing of Takeda’svaccine products; involved in exploration of Next GenerationSequencing for adventitious agents testing across differentfunctions; act as author and reviewer for Standard OperatingProcedures (SOPs), Analytical Risk Assessments, ProductSpecifications, Laboratory Investigations, Change Controls,Deviations, CAPA, Protocols and Reports. Less than 5% domestic andinternational travel required to attend meetings or CMO/CRO sites.

Up to 20% remote work allowed.

REQUIREMENTS

Master’s degree inCell and Molecular Biology, Plant and Animal Genetics, or relatedfield, plus 10 years of related experience.

Prior experience mustinclude:

increase efficiency in developing new vaccine methods orbiologic assay by leveraging training in Design of Experiment,statistical methodologies and JMP, and stay current with vaccineliterature, virology, biochemistry, molecular biology and vaccinedevelopment; develop and validate vaccine or biologic assays with afocus on accuracy and reliability, ensuring compliance withregulatory requirements, including GMP, GLP, FDA, and ISOstandards; streamline documentation and project management usingadvanced skills in word processing, data presentation, andMicrosoft Project; exhibit strong oral and written communicationsskills to effective reporting and collaboration withinmultidisciplinary teams; and demonstrate reliability andresponsibility by prioritizing tasks and working effectively inteam to contribute positively to overall project goals. Full time.$126,800 to $191,600 per year. Competitive compensation andbenefits. Qualified applicants can apply at https://jobs.takeda.com. Please reference job

R0149712 . EOE

Any individual may providedocumentary evidence bearing on this application, with informationon available workers and information on wages and workingconditions, to the Certifying Officer, U.S. Department of Labor,Employment and Training Administration, Office of Foreign LaborCertification, 200 Constitution Avenue, NW, Room N-5311,Washington, DC 20210. Locations Boston, MA Worker Type EmployeeWorker Sub-Type Regular Time Type Full time