Specialist External Analytical Sciences

Job Description

Join our Global Quality organization and play a key role in ensuring the uninterrupted supply of life-changing biologics and vaccines to patients worldwide. This is a highly visible role where analytical expertise, stakeholder management and external laboratory oversight come together in a dynamic international environment.

For our Oss site, we are looking for a: Specialist External Analytical Sciences

• →Provide analytical oversight for commercial large molecule biologics and vaccines products within the external testing network.
• →Act as the primary technical contact for external testing laboratories and manufacturing partners.
• →Build strong relationships with internal and external stakeholders while supporting governance and cross-functional collaboration.
• →Lead analytical investigations, deviations and troubleshooting activities to resolve complex testing challenges.
• →Drive continuous improvement initiatives to enhance analytical performance, compliance and operational efficiency.
• →Support analytical method lifecycle activities, including method transfer, validation and performance monitoring.
• →Manage projects, timelines and deliverables across multiple analytical and commercial initiatives.
• →Ensure inspection readiness and regulatory compliance while authoring and reviewing technical documentation supporting product release, licensure and regulatory submissions.

• Bachelor's degree in Biology, Chemistry, Biochemistry or another relevant scientific discipline with at least 5 years of relevant industry experience; or
• Master's degree in a relevant scientific discipline with at least 4 years of relevant industry experience; or
• PhD in a relevant scientific discipline with at least 2 years of relevant industry experience.
• Minimum 2 years of experience within a laboratory environment focused on biologics, vaccines or other large molecule products.
• Experience with analytical method development, validation, transfer and lifecycle management.
• Strong knowledge of analytical testing for biologics and vaccines, including techniques such as ELISA, cell-based assays and chromatography methods.
• Experience within biopharmaceutical manufacturing, Quality Control, Technical Operations or commercial product support in a GxP environment.
• Knowledge of analytical product lifecycle activities, including IPCs, method transfer, validation, release testing, stability testing and applicable regulatory requirements (ICH, USP, Ph. Eur.).
• Excellent communication, project management and stakeholder management skills, with the ability to troubleshoot complex issues and effectively collaborate with internal and external partners.

Current Employees apply HERE

Current Contingent Workers apply HERE