Our CMC development team is expanding, and we are looking for a
(SR.) CMC MANAGER ANALYTICSsupporting 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.
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.
- PhD or equivalent degree in Biochemistry, Organic Chemistry, Pharmaceutical Sciences or related field
- Minimum of 5 years of significant analytical CMC experience in the (bio)pharmaceutical industry
- Good knowledge of GMP and CMC considerations related to the manufacture of (bio)pharmaceutical products
- Understanding of analytical development and validation, GMP release testing, and stability studies.
- Ideally, experience in supporting the transition of products from clinical phase to commercialization
- Experience in collaboration with external vendors and subcontractors
- Very good communication skills including excellent command of English
- You are motivated to work on an innovative solution for a tremendous global problem
- You are known to walk the extra mile when needed, you do not settle for the sub‑optimal
- You are interested in building and contributing to a fun, supportive, yet critical team
- You have a strong attention to detail with excellent organization and presentation skills
Ideally our new CMC Manager started yesterday, or at least as soon as possible. But we are willing to wait for the best candidate, so we understand you have a notice period or already planned your annual leave. We are an equal opportunity employer, so we firmly believe that people thrive in a diverse and inclusive team. We are looking for people who can make an impact and work on our purpose, together.
Are you as excited about Leyden Labs, our mission and the role as we are? Then please hit the button and let me know you’re interested by sending me a short cover letter and your cv and I will get in touch within 4 working days to plan a first call. Also do not hesitate to reach out should you have any questions.
#J-18808-Ljbffr€70000 - €90000 monthly