Senior Manager, CMC Biologics

Jobtailor; München; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobtailor in Munich is seeking a senior CMC/Regulatory Submissions expert to author and oversee GMP/CMC documentation for late-stage development and PPQ activities.

You will collaborate with CDMOs, QPs, and internal teams to ensure regulatory submissions meet global expectations and project milestones, leveraging your deep knowledge of biologics and cGMP.

Qualifikationen

• 7+ years of experience in the biopharmaceutical industry.
• Strong background in CMC Development and GMP documentation.
• Experience with regulatory submissions (BLA/NDA) preferred.
• Familiarity with global cGMPs and ICH guidelines.
• Excellent technical writing and communication skills.

Aufgaben

• Author, review, and maintain CMC and GMP documentation.
• Prepare and review technical docs for development, manufacturing, tech transfer, validation, PPQ.
• Support late-stage GMP manufacturing, commercial readiness, PPQ execution.
• Collaborate with CDMOs, QPs, and internal stakeholders to ensure program delivery.
• Contribute to CMC content for global regulatory submissions.
• Act as SME for investigations, tech transfer activities.
• Partner with Regulatory Affairs, QA, and Project Management to ensure milestones.
• Maintain effective communication with stakeholders.

Kenntnisse

CMC Development

GMP Documentation

Technical Writing

Regulatory Submissions

Biologics Knowledge

Phase III Support

PPQ Execution

Cross-functional Collaboration

Ausbildung

Advanced degree in life sciences

Jobbeschreibung

• 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.

Highest-signal resume keywords

• CMC Development
• GMP Documentation
• Technical Writing
• Regulatory Submissions
• Biologics Development

Hard Skills

• CMC Documentation
• GMP Compliance
• Technical Operations
• Process Development
• Analytics
• Manufacturing Sciences
• Biologics Knowledge
• Regulatory Requirements
• Phase III Support
• PPQ Execution

Soft Skills

• Proactive Mindset
• Structured Approach
• Effective Communication

Industry Keywords

• Biopharmaceutical Industry
• ICH Guidelines
• Global Regulatory Expectations
• Qualified Persons
• CDMOs
• CROs