Das ist der Job
Proven ability to manage CMO relationships, conduct risk assessments, and author regulatory submissions.
Darum lohnt es sich
Job Responsibilities
• Lead operational oversight of clinical external manufacturing (CMO) of drug product
• Develop and execute robust, phase‑appropriate aseptic strategies for monoclonal and bispecific antibody drug products
• Manage CMOs and technology transfer of processes to external Contract Manufacturing Organizations
• Ensure strict adherence to cGMP requirements and global health authority expectations regarding aseptic controls
• Collaborate with formulation and device development teams to create stable, high‑concentration liquid formulations
• Execute risk assessments and define process control strategies using QbD principles
• Troubleshoot manufacturing issues, analyze data, and implement process improvements
• Lead deviation investigations, CAPAs, and change controls
• Review CMC sections for regulatory submissions including INDs, IMPDs, and BLAs
• Serve as a subject‑matter expert during regulatory agency interactions
• Manage vendor and CDMO relationships, ensuring alignment with project deliverables, budgets, and timelines
Requirements
• Bachelor of Science and 12 years or Master’s and 10+ years of experience in Chemical Engineering, Biochemistry, Pharmaceutics, or related scientific discipline
• 10+ years’ experience in drug product CMC support
• Up to 5‑10% of travel required
• Deep understanding of protein stability, prefilled syringe handling, isolator/RABS technologies, and sterile manufacturing
• Extensive knowledge of cGMP standards, ICH guidelines, and authoring BLAs for commercialization
• Proven track record as a people leader with strong cross‑functional communication and strategic problem‑solving abilities
Core Competencies
Demonstrates expertise in leading clinical external manufacturing operations, ensuring compliance with cGMP standards, and executing aseptic strategies for monoclonal and bispecific antibody drug products.
