mRNA CMC Lead

We are seeking an experienced mRNA LNP CMC Lead to join our R&D center in Barcelona and contribute to delivering innovative biopharmaceuticals to Dermatology patients.

As our mRNA LNP CMC Lead, you will be a key member of the mRNA LNP projects, responsible for leading and coordinating all mRNA LNP CMC activities within the R&D organization, collaborating with a network of CDMOs and partners. Your role encompasses 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.

You will work closely with colleagues across various departments and maintain communication 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. 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, including protocols, reports, and regulatory submissions.
6. Troubleshoot technical issues related to mRNA LNP development and manufacturing.
7. Stay updated on 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 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

• Knowledge of quality systems, GMP requirements, and regulatory processes.
• Experience leading 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 focusing on CMC aspects.

Values

Our core values: Care, Courage, Innovation, and Simplicity are embedded in all we do, guiding our mission and vision toward the future.