Dominik Schäfer

Biotech Operations Manager | USP & DSP Manufacturing | Scale-up, GMP Compliance & Team Leadership

Frankfurt, Hesse, Germany

About

I am a Biochemical Engineer (Dr.-Ing.) with a strong focus on bridging science and industrial manufacturing. With over 5 years of experience in the biotech industry, I specialize in scaling bioprocesses from early development to robust, large-scale production (USP & DSP). In my current role as Operations Manager Production USP & DSP, I lead end-to-end manufacturing operations, ensuring reliable, compliant, and efficient production. I oversee large-scale fermentation and downstream processing while driving operational excellence, continuous improvement, and performance optimization across the organization. I lead and develop an organization of ~40 employees and work closely with cross-functional teams including Quality, Engineering, and Supply Chain to ensure sustainable production performance. In addition, I contribute to budget planning and focus on cost-efficient, KPI-driven manufacturing. My core strength lies in translating complex biotechnological processes into scalable and reliable manufacturing systems, while aligning operational execution with strategic objectives. I am passionate about building high-performing teams, driving operational excellence, and taking ownership in dynamic, high-stakes environments.

Experience

  • Corden BioChem (Full-time · 5 yrs 4 mos)
    • Operations Manager Production USP & DSP
      Feb 2026 - Present · 5 mos

      • Lead daily USP and DSP production operations, ensuring reliable end-to-end manufacturing performance • Drive process optimization, operational excellence, and continuous improvement initiatives across USP and DSP • Oversee large-scale fermentation and purification, maintaining high product quality and yield • Ensure compliance with regulations, safety standards, and internal procedures throughout all production stages • Coordinate cross-functional collaboration with Quality, Engineering, and Supply Chain to support production • Monitor KPIs to improve throughput, reduce deviations, and enhance overall plant performance

    • Plant Assistant USP & Head of Microbiological Quality Control (QCM)
      Mar 2025 - Feb 2026 · 1 yr

      • Co-lead daily operations and drive strategic initiatives in collaboration with the Plant Manager • Drive process optimization, technology implementation, and scale-up activities to improve efficiency • Oversaw microbiological quality control (QCM) in line with regulatory and certification standars • Ensureed biosafety and regulatory compliance (GenTSV §28(5)) • Lead and developed a multidisciplinary team across production and quality functions • Ensured compliance with certification standards (e.g., FSSC, GMP+, ISO)

    • Project & Process Manager USP
      Mar 2021 - Mar 2025 · 4 yrs 1 mo

      • Led process engineering activities across technology transfer, process development, optimization, and scale-up • Coordinated cross-functional teams to implement new products into large-scale production • Acted as primary technical key contact for technology transfer and routine operations. • Supported upstream operations as Deputy Plant Manager • Ensured biosafety and regulatory compliance (GenTSV §28(5))

  • Research Scientist (Institute of Biochemical Engineering) & Doctoral Candidate at TU Munich at Technische Universität München
    Dec 2017 - Mar 2021 · 3 yrs 4 mos

    • Contributed to the BMBF-funded joint project PRO-SUGAR • Developed biotechnological processes for the production of sugar monomers from agricultural residues • Utilized Aspergillus niger in upstream fermentation and bioprocess developmen • Focus on bioprocess optimization, substrate utilization, and fermentation control