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Senior Manager, Biologics Analytical Development (Bioassay)

Otsuka

United States, United States, United States Full time July 21, 2026
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Vacancy Description

The Sr. Manager, Biologics Analytical Development (Bioassay) will execute and support the development, qualification, and lifecycle management of bioassays supporting biologics programs from early development through late-stage clinical and commercial manufacturing. This role provides scientific technical oversight n for cell-based and ligand-binding assays to support product characterization, potency determination, comparability, and regulatory submissions.

Key Responsibilities

  • Execute and support development, optimization, qualification, and validation of bioassays, including:Cell-based potency assaysBinding and functional bioassays (e.g., ELISA, MSD, SPR, flow cytometry)
  • Support development of assay strategies aligned with regulatory expectations for biologics.
  • Manage assay robustness, transfer, and comparability across product lifecycle stages.
  • Serve as subject matter expert (SME) resource supporting bioassays activities on cross-funct...

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    Vacancy Details

    Location United States, United States
    Country United States
    Type Full time
    Category Life Scientists
    Posted July 21, 2026

    About Otsuka

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    Otsuka

    United States, United States

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