This job ad has been posted over 40 days ago...

Full-time Head of CMC

at Versantis in Zurich CH

The position

The goal of this position is to scale-up the GMP production, validate the manufacturing processes as well as optimize and manage the supply chains of Versantis’ products in view of multi-sites clinical trials and commercialization. The successful candidate will be a highly motivated, entrepreneurial, CMC expert with large hands-on experience across all phases of drug development. This is a unique opportunity to significantly contribute to the success of a disruptive therapy tackling high unmet medical needs while being part a promising early-stage biotechnology company.

Duties and responsibilities

  • Work closely with the senior executive team in a collaborative and welcoming environment. 
  • Identify, select, and manage CROs/CDMOs.
  • Deliver and continuously work on optimizing robust, scalable, and cost-effective manufacturing routes, from raw materials to packaging.
  • Prepare or edit quality agreements with third-party manufacturers.
  • Drive third-party manufacturers through technology transfer, process and method development, and analytical qualification/validation of all manufacturing operations.
  • Prepare, review or edit all required documents prior to GMP productions (e.g., cGMP batch records, product specifications, in-process controls etc….).
  • Manage all QC/QA relevant issues and support third-parties’ investigations (out of specifications, stability issues…).
  • Anticipate the needs and ensure timely supply of drug product to support on-going non-clinical a...
Read the full job description on Startup Jobs by investiere

Recent jobs at Versantis
Full-time Head of CMC (w/m) 100% at Versantis in Zurich 16-12-2019

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Published at 16-12-2019
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