Senior Manager, CMC Biologics

Stellenbeschreibung:

Author, review, and maintain CMC and GMP documentation in accordance with regulatory requirements and industry best practices
Prepare and review technical and GMP documentation supporting development, manufacturing, technology transfer, validation, and PPQ activities
Support late-stage GMP manufacturing, commercial readiness, and PPQ execution
Collaborate with CDMOs, CROs, Qualified Persons (QPs), and internal stakeholders to ensure successful program delivery
Contribute to CMC content for BLA, NDA, and other global regulatory submissions
Act as a key scientific subject matter expert (SME), supporting manufacturing investigations, technical issue resolution, and technology transfer activities
Partner with CMC Biologics, Regulatory Affairs, Quality Assurance, and Project Management teams to ensure milestones, supply continuity, and compliance
Maintain effective communication with internal and external stakeholders

Requirements

advanced degree in a natural or life sciences discipline
7+ years of relevant experience in the biopharmaceutical industry
background in CMC Development, Technical Operations, Process Development, Analytics, Manufacturing Sciences, or related functions
solid knowledge of biologics development, preferably antibodies
ideally have experience supporting late-stage development programs, including Phase III, PPQ, and regulatory submission activities
strong understanding of cGMP requirements, ICH guidelines, and global regulatory expectations
excellent technical writing skills
highly proactive professional with a structured and solution-oriented mindset
excellent English skills (at least C1 level)
preferably proficiency in German

Core Competencies

Demonstrates expertise in CMC Development and GMP documentation, with a strong focus on biologics and regulatory submissions. Proficient in technical writing and collaboration with cross-functional teams to ensure compliance and successful program delivery.