Frankfurt, Hesse, Germany
Senior leader with extensive leadership experience in liquid & solid manufacturing. Guided and developed highly effective, cross-functional teams to ensure cGMP standards, operational performance & safety, utilizing VACC principles (Visionary, Architect, Coach, Catalyst). Hands-on knowledge in process and cleaning validation, equipment qualification, change management and regulatory inspections – both, as an certified GMP-auditor and as main representative of department in internal & external audits.
•Following re-organzitation, I assumed strategic and disciplinary leadership for a department of 60+ specialists across Operations, Maintenance, Project Engineering, Site Services, and Pharmaceutical Technologies, expanding responsibilities. • Expanded role includes overseeing the maintenance, qualification, and optimization of technical equipment and media systems and validation of manufacturing & cleaning processes as Technical System Owner to ensure reliable production. • Took on responsibility for managing the site-wide CAPEX budget, including the development and execution of long- and mid-term investments in infrastructure and technical systems.
• Overall responsibility for liquid formulation, filling, and packaging at Bayer PSDC Darmstadt as part of the Site Leadership Team • Ensuring the achievement of site volume and cost targets (production volume: >15 million packaging units per year) • Representation of the department in GMP-Audits of authorities and internal QA • Personnel management and development (Direct Reports: 3, Indirect Reports: 30) • Further development of GMP, Lean, and HSE standards in the work areas
Continuation of the activities mentioned below - additionally: • Main contact of department for quality topics - responsible for ensuring GMP compliance in the manufacturing area • Initiating and tracking of change control procedures for processes & procedures • Disciplinary guidance and development of a five-member team
• Coordination of development & transfer projects for solid drugs in an international GMP environment • Supervision of the development and validation of analytical methods & manufacturing processes • Alignment of priorities and timeline with clients and external service providers
• Supervision of the practical course "Pharmaceutical Analysis" • Mentoring and training of students and research interns
• Providing part-time relief services in the pharmacy
• Responding to pharmaceutical inquiries from doctors and pharmacists • Writing and revising internal and external product information