We are seeking an experienced mRNA LNP CMC Lead to join our R&D center in Barcelona and contribute to delivering innovative biopharmaceuticals for Dermatology patients.
As the mRNA LNP CMC Lead, you will play a key role in managing mRNA LNP projects within our organization. Your primary responsibilities will include leading and coordinating all mRNA LNP CMC activities across the R&D organization through a network of CDMOs and partners, covering process and analytical method development up to GMP manufacturing of Active Ingredient and Drug Product. You will also participate in preparing CMC sections of regulatory documentation. We value hands-on experience in mRNA LNPs and encourage sharing your expertise to advance our projects.
You will collaborate closely with colleagues across various departments, participating in multidisciplinary project teams and working with our global network of Contract Development and Manufacturing Organizations (CDMOs).
Tasks and Responsibilities
* Lead and coordinate the mRNA LNP CMC strategy for development projects (preclinical and clinical stages).
* Oversee and manage outsourced activities at CDMOs, including development and GMP manufacturing.
* Collaborate with R&D, Quality, Regulatory Affairs, and Supply Chain teams.
* Develop and implement CMC strategies aligned with project timelines and goals.
* Review and approve technical documents such as protocols, reports, and regulatory submissions.
* Troubleshoot and resolve technical issues related to mRNA LNP development and manufacturing.
* Stay updated on industry trends and technological advancements in mRNA LNPs.
* Author and review CMC regulatory documents.
* Enhance organizational knowledge on mRNA-LNP (CMC).
Education
* Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields.
* 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.
* Leadership experience in cross-functional teams.
* Strong collaboration skills and experience working with external partners.
* Proficiency in English communication skills.
Experience
Minimum of 8 years in pharmaceutical or biotech industries with a focus on CMC.
Values
Our core values: Care, Courage, Innovation, and Simplicity are embedded in our culture and drive our mission and vision for the future.
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