About the position
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.
Responsibilities
- Collaborate with Project Managers and Contract Manufacturing Organizations (CMO) on GMP Dengue vaccine manufacturing.
- Provide analytical testing support/troubleshooting of cell bank and working virus seed.
- Act as project lead on development of an in-house specialized immunoassay for Host Cell Protein (HCP).
- Manage CRO's project timelines and provide scientific expertise.
- Review and approve CRO's Study protocols for Method Development, Bridging studies and Qualification.
- Participate in internal audit for external manufacturing sites.
- Provide regulatory support and responses to agency requests for information.
- Provide technical support to external laboratories and national laboratories.
- Explore Next Generation Sequencing for adventitious agents testing.
- Act as author and reviewer for SOPs, Analytical Risk Assessments, Product Specifications, Laboratory Investigations, Change Controls, Deviations, CAPA, Protocols and Reports.
Requirements
- Master's degree in Cell and Molecular Biology, Plant and Animal Genetics, or related field.
- 10 years of related experience.
- Experience in developing new vaccine methods or biologic assay using Design of Experiment and statistical methodologies.
- Ability to develop and validate vaccine or biologic assays ensuring compliance with regulatory requirements.
- Advanced skills in word processing, data presentation, and Microsoft Project.
- Strong oral and written communication skills.
- Ability to prioritize tasks and work effectively in a team.
Benefits
- Competitive compensation and benefits.
