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CMC Project Specialist

Neurimmune AG
Schlieren

2W

Neurimmune AG is a biopharmaceutical company focused on the development of a unique class of human antibody therapeutics for the treatment of diseases with high unmet medical need. To further strengthen our organization, we are recruiting for a:

CMC Project Specialist

We are looking for a motivated person who is willing to work in the Zurich area on a full-time, permanent basis.

Responsibilities include:

  • Manage assigned CMC activities for Neurimmune product candidates from pre-clinical through clinical development stages.
  • Evaluate and manage external service providers (CDMOs, CLOs) for respective CMC deliverables.
  • Ensure regulatory compliance of outsourced CMC activities in support of clinical studies.
  • Monitor, analyze and report CMC project status to CMC Project Lead and project teams.
  • Compile and maintain CMC documentation in compliance with regulatory requirements by FDA, EMA, and Swissmedic.

Requirements:

  • Life Sciences background (MSc in Biotechnology, Biochemistry, Cell Biology or equivalent is required).
  • At least 2 years professional experience in a CMC area or in managing CMC activities (ideally in process and/or analytical development, packaging and/or product characterization).
  • Experience in working in a GMP environment or proven record of GMP knowledge; ideally in the field of biologics.
  • Fluency in English (mandatory) and German.
  • Excellent interpersonal and communicative skills.
  • Well organized, self-motivated and ability to work efficiently with a focus on deliverables.

If you are interested, please forward your CV and motivation letter to:

Christine Frei, Human Resources, Neurimmune AG, Wagistrasse 18, CH-8952 Schlieren.
hr@neurimmune.com