CMC Manager
Leyden Labs
Job description
For the CMC development team we are looking to hire a
CMC MANAGER
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 process development, scale-up, GMP production and analytical method development, combined with working experience in CMC/GMP management.
More about the team:
Our CMC team currently includes a Senior Manager, a Senior Scientist, 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. We are delighted to be at a pivotal moment in our journey having recently secured a further $70M in funding. 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.
This is what are you going to do on a daily basis and these are your responsibilities:
Management of CMC operational activities, e.g. defining of critical quality attributes and critical process parameters, overseeing in-process controls and, process validation, ensuring starting material and drug substance/product quality, characterization, and coordinating stability studies
Coordination of development tasks towards collection of required information and contribution to respective documents (e.g. risk analysis, briefing books, IND, IMPD, study plans and reports) in close collaboration with other technical teams and the regulatory affairs team
Communication with CMOs and analytical laboratories for GMP manufacturing and quality control for supply of clinical studies
(Support) management of production process for lead product
Establish collaborations with CMOs for production of biologics, including peptides and monoclonal antibodies
Job requirements
MSc or equivalent degree in Biochemistry, Organic Chemistry, Pharmaceutical Sciences or related field
Minimum of 5 years of significant CMC experience in the (bio)pharmaceutical industry
Good knowledge of GMP and CMC considerations related to the manufacture of (bio)pharmaceutical products
Understanding of process development, scale-up, GMP production and analytical method development
Knowledge of formulation and production processes relating to pharmaceutical development. Ideally, experience in supporting the transfer of products from development to market
Experience in collaboration with external vendors and subcontractors
Very good communication skills including excellent command of English
About you:
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 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. The team works a hybrid on-site schedule, and 2-3 days on-site in the office are required and on-site interviews are part of the recruitment process. Therefore, we are looking for someone who is currently residing in the Netherlands with eligibility to work in the EU.
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 2-3 weeks to plan a first call.
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