We are looking for an experienced mRNA LNP CMC Lead to join our R&D center in Barcelona and help us bring innovative biopharmaceuticals to dermatology patients.
Our pipeline is growing, and we need your expertise to ensure our goals are met.
As the mRNA LNP CMC Lead, you will be a key member of the mRNA LNP projects team. Your primary role will be to lead and coordinate all mRNA LNP CMC activities within the R&D organization, working with a network of CDMOs and partners. This includes process and analytical method development, GMP manufacturing of Active Ingredient and Drug Product, and contributing to regulatory documentation. We seek someone with hands-on experience in mRNA LNPs who is eager to share their expertise in developing such projects.
You will collaborate closely with colleagues across various departments and work within multidisciplinary project teams, maintaining close contact with our global network of CDMOs.
Tasks and Responsibilities
1. Lead and coordinate the mRNA LNP CMC strategy for development projects (preclinical and clinical).
2. Oversee and manage outsourced activities at CDMOs, including development and GMP manufacturing.
3. Collaborate with R&D, Quality, Regulatory Affairs, and Supply Chain teams.
4. Develop and implement CMC strategies aligned with project timelines and goals.
5. Review and approve technical documents such as protocols, reports, and regulatory submissions.
6. Troubleshoot and resolve technical issues related to mRNA LNP development and manufacturing.
7. Stay current with industry trends and advancements in mRNA LNP technology.
8. Author and review CMC regulatory documents.
9. Enhance organizational knowledge on mRNA-LNP (CMC).
Education
* Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
* At least 8 years of experience in the pharmaceutical or biotech industry, focusing on CMC.
* Specific expertise in mRNA LNPs.
* Proven experience managing CMC activities and overseeing outsourced development and manufacturing.
* Strong understanding of regulatory requirements for mRNA LNP products.
* Excellent project management and organizational skills.
* Ability to thrive in a fast-paced, dynamic environment.
* Effective communication and interpersonal skills.
Specific Knowledge
* Familiarity with quality systems, GMP requirements, and regulatory processes.
* Ability to lead cross-functional teams.
* Strong collaboration skills and experience working with external partners.
* Proficiency in English communication.
Experience
Minimum of 8 years in the pharmaceutical or biotech industry, with a focus on CMC.
Values
Our core values: Care, Courage, Innovation, and Simplicity are embedded in everything we do. They underpin our mission and vision, guiding us today and into the future.
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