(Senior) Scientist - Quality Control (m/f/d)

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.

We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world's first and only chikungunya vaccine, as well as certain third-party vaccines.

Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.

Responsibilities

• Assay planning, analysis, review and troubleshooting of established routine methodologies (scientific, technical and organizational aspects)
• Writing GxP documents (technical protocols/reports, validation documents, analytical testing, SOPs)
• Verification and validation of assays used for release and stability testing as well as validation of computerized systems
• Qualification of analytical equipment, deviation and change management
• Assay transfer and interpretation of results for the release of raw materials, intermediate products and final products, including preparation/completion of protocols and reports
• Execution of analytical procedures, for testing of test, release and stability samples, according to defined Standard Operating Procedures, and protocols in compliance with the same
• Compliance with and continuous improvement of best cGMP working standards
• Collaborate with internal and external stakeholders to advance projects