Activity

R&D

Location

Sophia-Antipolis

Country

France

Reference

CMC-APIMAN0419

Responsabilities

The candidate is in charge of all the aspects of API management within the Nicox group. A CMC expert used to working with CMOs within a US/EU-GMP environment, the CMC-API Director is responsible for the development and the manufacturing of new chemical entities generated by the Company’s research department for both early and late stage molecules. The candidate is also in charge of other pharmaceutical ingredient sourcing from the market, including other APIs, intermediates and pharmaceutical excipients. The candidate is responsible for the definition, the organization and the implementation of the manufacturing plan for the Company’s molecules from the research phase and until the end of the Phase 3 clinical. He/she drives the building of the 3.2.S part of the drug registration dossier.

Profil

To apply, candidates must have a Chemical Engineer or a Bachelor of Science degree, ideally with an additional qualification in API manufacturing, or a significant experience and track record “on the job”. The CMC-API Director is the company expert for all pharmaceutical ingredients. A strong background in GMP manufacturing of pharmaceutical drug substances is required for this position. At least 5 years, experience ideally 10 years, in API manufacturing development and transfer is required. As the leader of the API development process for the whole Nicox group, the candidate must demonstrate good personal organization and robust skills in project management. Fluent English is mandatory. Travels abroad will be required.