About the vacancy
Drug Development
Infectious Diseases & Vaccines
Respiratory & Pulmonary Disorders
Small molecules
Manufacturing
Clinical R&D
About Your Next Job
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.
About Your Next Colleagues
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.
About Your Tasks and Responsibilities
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
About Your Skills and Experience
- 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 inhaled product combinations such as dry powder inhalers, nebules and intranasal products is considered a pré.
- Experience in collaboration with external vendors and subcontractors
- Very good communication skills including excellent command of English
Where Molecules Meet Opportunities
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.
Only apply if...
You have at least 5 years ofCMC experience in drug-device combiniation products.
You are eligible to work in EU
We only accept applicants who are eligible to work in the EU
Contact person
Maisi Man
No video available
Leyden Labs is a Dutch biotechnology company employing a novel, non-vaccine approach to fight back against the threat of respiratory viruses. The goal is to provide unprecedented breadth of protection against respiratory viruses right in the palm of the hand of those who need protection the most. The company's product candidates are nasal sprays that are developed following the principles that they must provide protection right at the gate of viral entry (in the airway) and deliver superior breadth of protection. These product candidates offer an opportunity to overcome major limitations of existing vaccine-based protection.