(Sr.) CMC Manager Analytics
Our CMC development team is expanding, and we are looking for a
(SR.) CMC MANAGER ANALYTICS
supporting all (pre) clinical projects with respect to production of Leyden Labs products, product quality, and CMC documentation for regulatory dossiers.
The ideal candidate is someone who has an understanding of analytical development and method validation, GMP release testing and stability studies, combined with working experience in CMC/GMP project management for the management of CMO and analytical contract labs.
This is what are you going to do on a daily basis and these are your responsibilities:
Management of early and late stage CMC operational activities, e.g. define critical to quality attributes, spec setting, method development & validation, GMP DS and DP release & stability testing and trouble shooting
Coordination of development tasks towards collection of required information and contribution to respective documents (e.g. risk analysis, method descriptions, stability plans and reports, JoS, briefing books, IND, IMPD, BLA, study plans and reports) in close collaboration with other technical teams and the regulatory affairs team
Management and technical oversight of the analytical methods and stability programs for our product(s).
Manages the project invoices, budget tracking and final reconciliation
Effectively collaborate and communicate with CMOs and analytical contract laboratories selected for the production and testing of our lead product and with other functions of the project team.
More about the team:
Our CMC team currently includes two senior managers CMC, a principal technician and an associate scientist. In this role you will be reporting to the Director of CMC.
Why would you want to work with us:
With innovation at the forefront, Leyden Labs is on a mission to develop cutting-edge mucosal protection platforms designed to free people from the threat of respiratory viruses, such as influenza and coronaviruses. Working at Leyden Labs will give you the opportunity to work with a group of talented people and immerse yourself in truly meaningful medical science.