Job Description
OBJECTIVES:
The Manager, Analytical Development is responsible for leading and executing analytical method development, qualification, validation, and assay transfer activities to support biologics and vaccine development programs from early development through Phase 2 clinical trials. The position holder applies strong scientific judgement in the design and execution of analytical methods and is well-versed in current biologics analytical development trends across a broad range of modalities, including viral, mRNA, and protein-based vaccines.
The position holder manages a team of analytical scientists and provides hands-on scientific leadership and project ownership. The role works in close collaboration with Early Development and Preclinical, Process Development, Quality Control, Regulatory Affairs, and external partners to ensure analytical readiness, non-GMP testing support, compliance with regulatory expectations, and timely program progression.
RESPONSIBILITIES:
Anal...
The Manager, Analytical Development is responsible for leading and executing analytical method development, qualification, validation, and assay transfer activities to support biologics and vaccine development programs from early development through Phase 2 clinical trials. The position holder applies strong scientific judgement in the design and execution of analytical methods and is well-versed in current biologics analytical development trends across a broad range of modalities, including viral, mRNA, and protein-based vaccines.
The position holder manages a team of analytical scientists and provides hands-on scientific leadership and project ownership. The role works in close collaboration with Early Development and Preclinical, Process Development, Quality Control, Regulatory Affairs, and external partners to ensure analytical readiness, non-GMP testing support, compliance with regulatory expectations, and timely program progression.
RESPONSIBILITIES:
Anal...
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