Fischbachau, Bavaria, Germany
Currently serving as Deputy Head of Production at AMW GmbH, with expertise in cGMP-compliant manufacturing and sterile drug delivery systems. Focused on scaling operations for biodegradable implants and combination products, contributing to advancements in pharmaceutical and medical device production. Core strengths include process optimization, automation, and fostering operational efficiency through Lean Manufacturing principles. With over eight years of experience in pharmaceutical manufacturing and quality management, dedicated to driving compliant, high-quality production frameworks. Passionate about creating collaborative environments that empower teams to achieve sustainable progress and operational excellence. Skilled in implementing scalable solutions and ensuring manufacturing processes align with industry standards and organizational goals.
Drug Product Manufacturing Sterile Drug Delivery Systems | Biodegradable Implants | Hot Melt Extrusion | CDMO | Combination Products (Pharma & Medical Device) Oversee manufacturing operations for sterile drug delivery systems, including biodegradable implants produced via hot melt extrusion, within a CDMO environment serving both pharmaceutical and medical device sectors Drive upscaling of the value stream, including packaging processes and implementation of process automation Structure and optimize process manufacturing frameworks to ensure scalability, compliance, and operational efficiency Lead the implementation of Lean Manufacturing principles to foster continuous improvement and operational excellence Manage strategic capacity expansion initiatives to support long-term growth and innovation
Reporting, Contractor Management, Trending, QMS, Audit Management, maintaining Accreditation, Site Master File responsible, SPOC for Health authorities
Tactical Manufacturing - Qualification, Audits and SOPs.
Responsible for DSP process and 22 employes.
• Conducted analytical research focused on method development for product safety at the Fraunhofer Institute. • Developed a thesis on the differentiation, identification, and quantification of MOSH and MOAH using advanced techniques. • Utilized GCxGC, LCMS, and GPC methodologies to enhance product safety standards in the packaging industry.
Development recycling of polymers: logistics, maintenance and supervision of scale-up tests (from laboratory to 200 L).