Senior Manager, Particulate Analytics in Biotherapeutics

8525-Cilag GmbH International Legal Entity

Schaffhausen

Presencial

CHF 180.000 - 240.000

Jornada completa

Hace 3 días
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Descripción de la vacante

Johnson & Johnson Schaffhausen is seeking a Scientific Senior Manager for Particulates Analytical Development. You will lead a team delivering end-to-end particle analytics for large-molecule projects, ensuring GMP-compliant strategies and clear regulatory narratives for submissions.

You will translate complex data into robust content, supervise the BSL-2 lab, and partner with global teams to advance analytical capabilities while upholding Credo-driven, inclusive leadership in a highly regulated

Formación

  • Master’s or PhD with extensive experience in analytical sciences or pharmaceutical sciences.
  • Experience in analytical method development, qualification, validation or transfer for particle counting.
  • Proven ability to translate complex data into regulatory narratives and submissions.

Responsabilidades

  • Provide scientific leadership for particulate matter analytics in cross-functional teams.
  • Define analytical strategies for visible and subvisible particulates aligned with product development.
  • Lead method development, validation, transfer and lifecycle activities for particulate assays.
  • Author and review technical and regulatory documents for regulatory submissions.
  • Coordinate deliverables with R&D, manufacturing, QC labs and external partners.

Conocimientos

Analytical skills
Biochemistry
CMC
Leadership
Regulatory submissions

Educación

Master’s degree in life sciences / engineering
PhD in life sciences

Descripción del empleo

Johnson & Johnson Schaffhausen is seeking a Scientific Senior Manager for Particulates Analytical Development. You will lead a team delivering end-to-end particle analytics for large-molecule projects, ensuring GMP-compliant strategies and clear regulatory narratives for submissions.

You will translate complex data into robust content, supervise the BSL-2 lab, and partner with global teams to advance analytical capabilities while upholding Credo-driven, inclusive leadership in a highly regulated

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