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Project/CMC manager

Leiden

About the company

20Med Therapeutics is a Dutch biotechnology company applying innovative nanotechnology to the development of vaccines and therapeutics. Our non-viral delivery platform is based on bio-responsive polymeric Nanoparticles specifically designed to meet the needs of next generation nucleic acid-based vaccines. We currently focus on the preclinical development of the technology in a prophylactic vaccine towards first in human use. Our long-term ambition is to provide an efficient platform technology that can be used for rapid response to emerging infectious diseases. To support the development of our growing pipeline of RNA and DNA based vaccines we are expanding our team in Leiden. 

Job Summary

As project and Chemistry, Manufacturing and Controls (CMC) manager you will bring the development of novel vaccines to the next phase. The position requires the ability to coordinate the development of RNA and DNA based polymeric nanoparticles vaccines for prophylactic and therapeutic applications. You will provide structure and support in multiple internal and external development projects and are the contact person for outsourced activities regarding the manufacturing and analysis of polymer-based nanoparticles and vaccines.

Location: Leiden, The Netherlands

Responsibilities

  • Project-, timeline- and document management

  • Coordinate in-house and external CMC development activities 

  • Support and collaborate with the scientific team performing in-house CMC activities

  • Support/manage the scale-up and transfer of manufacturing and formulation processes from R&D laboratory to GMP production

  • Help establish the CMC regulatory strategy and support activities. 

  • Collaborate with vaccine and formulation scientists for preparation of CMC sections of regulatory dossier

  • Contribute to the communication with regulatory authorities 

Qualifications

  • Background in (Bio) Chemistry, Pharmaceutical Sciences or related field

  • Minimum of 5-year experience in a pharmaceutical company and 2-year experience with CMC development

  • Experience in vaccine development; experience with mRNA or polymeric nano- or microparticles preferred

  • Strong knowledge of product and process development, GMP and regulatory requirements

  • Proven project management skills

  • Organized and structured

Our offer
We offer an exciting and innovative working environment in a young biotech organization, with competitive benefits including an annual performance bonus and flexible working arrangements. 

If you are interested please send your cover letter and resume to the following address, or get in touch if you have any questions: careers@20medtx.com

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