CMC Manager

Meletios Therapeutics is a French biotech, founded in April 2020, developing broad-spectrum treatments for viral infections. We have a pipeline of several candidates and our R&D is based on two complementary programs:

  • A Host Targeting Agent (HTA) program of small molecules targeting host mechanisms or functions hijacked by the virus.

MLT103 is our most advanced candidate and is part of our HTA program. It has demonstrated broad-spectrum activity against the entire family of coronaviruses and also H1N1 Influenza. Phase II of MLT103 is planned for H2 2023.

  • A program based on defective viral genome (DVG) technology from the Institut Pasteur. DVGs are RNA sequences that will parasitize the viral machinery.

Position:
Meletios Therapeutics is recruiting a CMC / Galenics / Pharmaceutical Development Manager

The mission is to take charge of the synthesis process and the supply of active ingredients, as well as the formulation and manufacturing of the products in the portfolio, taking into account the regulatory constraints, in order to allow the completion of preclinical studies and the first clinical phases of the products developed by the company in the targeted indications.

Missions:

Coordination of CMC activities, from the development of the chemical synthesis process, from galenics to industrial scale-up

  • Development of the active ingredient synthesis process with partners.
  • Process development and scale up.
  • Characterization/Analytical Validation API and Drug products.
  • Pre-formulation and formulation studies (outsourced).
  • Batch generation for toxicity studies and GMP batch for clinical studies
  • Follow-up of the production and validation of non-GMP and GMP batches
  • Conduct of CMC regulatory activities related to regulatory files
  • Follow-up/Drafting of scientific, technical and regulatory files (IMPD, eCTD, IND, NDA)
  • Search and evaluation of subcontractors,
  • Coordination of subcontractors involved in pharmaceutical development, in compliance with quality and regulatory standards, deadlines and costs
  • Management of preclinical and clinical logistics
  • Securing the supply of active ingredients

 

You have a scientific background (Master 2 Industrial Pharmacy / formulation / production processes, Chemical Engineer, PharmD or PhD). You have a solid knowledge of chemistry and galenics (properties of active ingredients, properties of excipients, galenic forms), associated manufacturing processes and regulatory requirements. You have a minimum of 5 years of successful experience related to the missions expected for this position.

 

You have a taste for challenge and you are motivated to join a young and innovative company. You are autonomous, innovative, have a strong sense of initiative and are attracted by teamwork. You communicate fluently in English, both in writing and orally, and have a sense of priorities and organization.

 

Position to be filled immediately. Paris

Contact: Please send your application to contact@meletiostx.com

 

 

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