mRNA CMC Lead

Almirall Hermal GmbH; Málaga; Presencial; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

An innovative biopharmaceutical company is seeking an experienced mRNA LNP CMC Lead to join their R&D team. In this pivotal role, you will spearhead the mRNA LNP CMC strategy, overseeing development projects from preclinical to clinical stages. Your expertise will guide cross-functional teams and ensure compliance with regulatory standards while collaborating with global partners. If you're passionate about advancing biopharmaceuticals and thrive in dynamic environments, this opportunity offers a chance to make a significant impact in the field of dermatology.

Formación

• 8+ years in pharma/biotech with CMC focus.
• Hands-on experience with mRNA LNPs and regulatory documentation.

Responsabilidades

• Lead mRNA LNP CMC strategy for development projects.
• Oversee outsourced activities at CDMOs and manage timelines.
• Collaborate with cross-functional teams and resolve technical issues.

Conocimientos

mRNA LNP expertise

Project management

Regulatory knowledge

Analytical method development

Collaboration skills

Problem-solving

Communication skills

Educación

Ph.D. in Chemistry

Ph.D. in Biochemistry

Ph.D. in Pharmaceutical Sciences

Herramientas

GMP standards

Quality systems

Descripción del empleo

We are looking for an experienced mRNA LNP CMC Lead to join the team in our R&D center in Barcelona and help us bring the best innovative biopharmaceuticals to Dermatology patients.

Our pipeline is growing, and we need your competences to secure our end goals are met.

As our mRNA LNP CMC Lead, you will be an instrumental team member of the mRNA LNP projects. The primary role of this position is to lead and coordinate all topics mRNA LNP CMC topics for the R&D organization through a network of CDMOs and partners, going from process and analytical method development, up to GMP manufacturing of Active ingredient and Drug Product. You will also contribute directly to CMC parts of regulatory documentation. We are looking for someone with hands-on experience in mRNA LNPs and that is willing to bring and share its experience in developing such projects.

You will work in close collaboration with colleagues across the organization, as a member in our multidisciplinary project teams and in close contact with our network of global Contract Development Manufacturing Organizations (CDMOs).

Tasks and Responsibilities

• Lead and coordinate the mRNA LNP CMC strategy for development projects (preclinical and clinical stage).
• Oversee and manage outsourced activities at CDMOs, including development and GMP manufacturing.
• Collaborate with cross-functional teams, including R&D, Quality, Regulatory Affairs, and Supply Chain.
• Develop and implement CMC strategies to support project timelines and objectives.
• Review and approve technical documents, including protocols, reports, and regulatory submissions.
• Troubleshoot and resolve technical issues related to mRNA LNP development and manufacturing.
• Stay current with industry trends and advancements in mRNA LNP technology.
• Author and review CMC regulatory documents.
• Enhance the organization knowledge on mRNA-LNP (CMC).

Education

• Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 8 years of experience in the pharmaceutical or biotechnology industry, with a focus on CMC aspects.
• Specific knowledge and experience with mRNA LNPs.
• Proven track record of 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 work effectively in a fast-paced, dynamic environment.
• Strong communication and interpersonal skills.

Specific Knowledge

• Familiarity with quality systems and GMP requirements and regulatory processes.
• Demonstrated ability to lead cross-functional teams.
• Strong collaboration skills and experience working with external partners.
• Communication skills in English.

Experience

Minimum of 8 years of experience in the pharmaceutical or biotechnology industry, with a focus on CMC aspects.

Values

Our strong values: Care, Courage, Innovation, and Simplicity are incorporated into everything we do, and they are behind our mission and vision which guide us today and lead us to the future.