(Sr.) CMC Manager Devices

For the CMC development team we are looking to hire a

(SR.) MANAGER CMC DEVICES

supporting all 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 the design, development, and lifecycle management of medical devices and drug-device combinations, thorough knowledge of the regulatory device requirements, combined with working experience in CMC/GMP project management for the management of CMO’s and suppliers.

This is what are you going to do on a daily basis and these are your responsibilities:

• Management of CMC operational activities from early to late-stage development, e.g. device selection for new drug-device combination products, risk management plan, L/E studies, device characterization and testing.

• Coordination of development tasks towards collection of required information and contribution to respective documents (e.g. risk analysis, briefing books, IND, IMPD, BLA, study plans and reports) in close collaboration with other technical teams and the regulatory affairs team

• Communication and collaboration with CMOs and device manufacturer ensuring seamless supply for clinical studies

• (Support) management of production process for lead product

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.

Requirements

• PhD or equivalent degree in in Engineering, Life Science or related field

• Minimum of 5 years of significant CMC experience in the (bio)pharmaceutical industry with a focus on medical devices and drug-device combinations

• Good knowledge of GMP and CMC considerations related to the manufacture of (bio)pharmaceutical products

• Understanding of development and life cycle management of drug-device combinations. Experience with nasal devices is considered a pré.

• Experience in collaboration with external vendors and subcontractors

• Very good communication skills including excellent command of English

More about you:

• Motivated to work on an innovative solution for a tremendous global problem

• Known to walk the extra mile when needed, you do not settle for the sub-optimal

• Interested in building and contributing to a fun, supportive, yet critical team

• Have a strong attention to detail with excellent organization and presentation skills

Ideally our new Manager CMC starts 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. Depending on the geographic location of the candidate remote or hybrid working are possible for this position. At this time we are only considering candidates currently residing in Europe. 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 reaching out should you have any questions.