Senior Manager, Particulate Analytics & Regulatory Strategy

Johnson & Johnson Co.

Schaffhausen

On-site

CHF 180,000 - 210,000

Full time

33 hours ago

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Job summary

Johnson & Johnson in Schaffhausen seeks a Scientific Senior Manager to lead the Particulates Analytical Development team. You will drive end-to-end analytics for large‑molecule programs, shaping strategies for visible and subvisible particulates in a GMP setting.

You will translate complex data into regulatory submissions, oversee the BSL-2 AD lab, mentor staff, and partner with R&D, QC, and external collaborators to advance analytical capabilities across the portfolio.

Qualifications

Master’s degree with 10+ years of industry experience in life sciences or related field.
Option for PhD with 7+ years of relevant experience in analytical sciences or pharmaceutical sciences.
Proven ability to translate analytic data into regulatory narratives and submissions.

Responsibilities

Provide scientific and strategic leadership for particulate matter analytics across development programs.
Lead method development, qualification, validation, transfer, and lifecycle activities for particulate assays.
Author and review regulatory documents and responses for health authority submissions.
Coordinate cross-functional work with R&D, manufacturing, and quality control teams.