Mühlhausen-Ehingen, Baden-Württemberg, Germany
Innovative and strategic leader with 14 years of industry experience in Vaccines Business Unit, Global Manufacturing Sciences, External Supply Operations and Manufacturing. Specialized in global program management, operating strategies, product manufacturing, and technology transfer. Demonstrated expertise in Biologics, Cell & Gene Therapies, Small Molecules, and Drug Product Manufacturing. Skilled in cross-functional team leadership and adept at managing complex projects with a focus on global programs, innovation and process improvement.
- Created and currently implementing an integrated knowledge management strategy that empowers the MS&T organization to excel in end-to-end process ownership, LCM & troubleshooting, scientific expertise, and robust, standardized tech transfers of manufacturing processes - Building the knowledge infrastructure for Agentic AI and driving the set up and integration of Agentic AI in daily operations to support MS&T business requirements - Digitizing MS&T labs in their lab operations, knowledge mgmt and capability development by successfully driving the selection of an Electronic Lab Notebook (ELN) together with DD&T and VBD - Driving the implementation of the Electronic Lab Notebook as Product Manager to define system design and data governance - Introduced the concept of collaborative learning to build Tribal Knowledge and fostering a Learning and Professional Development culture - Mapped out and introduced to the organization VBU Governance and Decision making process to streamline decision making
Mar. 2024 – Sept. 2024 Global Program & Project Manager for a strategic centralized cross-functional program sponsored by Global Manufacturing Science, Procurement and EHS - Managing a strategic program to mitigate significant business continuity risks associated with the ECHA proposal to ban PFAS - Addressed complex PFAS-related assessment challenges by coordinating cross-functional task forces and external consultants - Ensured program support through all management levels and sites by driving an effective global program communication and stakeholder management - Secured project success by ensuring adherence to timelines and budget Oct. 2021 – Sept. 2024 Global Manufacturing Science Labstrategy Lead - Developed and implemented successfully a global network strategy for 20 local Manufacturing Sciences laboratories (MSci) harmonizing MSci lab operations across GMS plants and fostering cross-functional collaboration by creating a unified framework for the network that enables faster and more consistent tech transfer, scale-up and life cycle management - Laid the foundation for a data-driven, highly automated and AI-enabled digital ecosystem by developing and implementing a digital strategy for MSci lab operations, starting with an Electronic Lab Notebook as fundamental architectural system - Increased local and global capabilities by creating and managing a portfolio of over 200 lab projects with an investment volume exceeding $150 million Feb. 2020 – Mar. 2023 Manufacturing Innovation Lead - Set strategic direction for innovative manufacturing processes by consulting on early-phase pipeline products - Drove innovation to build internal capabilities by developing global operating strategies in collaboration with global functions from Pharmaceutical Science, Strategy Business Excellence and Operating Units - Demonstrated company performance comparison with peers and industry technology trends by performing Business & Technology Intelligence studies
August 2018 – Feb. 2020 Transfer Lead for a large scale Product Transfer from Takeda to CMOs - Streamlining the manufacturing portfolio of a Takeda site by transferring seamlessly up to 28 products from the site to CMOs with the following product technologies: o Blow Fill Seal, Nasal Sprays, Ointments, Suppositories, Small liquids Apr. 2019 – Sept. 2019 Supplier Related Team (SRT) Lead - Ensured market supply in compliance (End to End Product Responsibility) with GMP, regulatory, and economic requirements by leading a cross-functional team - Optimized supply chain parameters to improve patient supply, COGs & KPIs
Oct. 2013 - Mar 2014 Project Lead, Operational Excellence Aseptic Project, Greenbelt training, Rentschler Biotechnologie GmbH - Led a project team and successfully performed an internal improvement project that standardized the assessment of environmental monitoring & microbial deviations using Lean Management and Six Sigma methods - Certified Lean Six Sigma Greenbelt Apr. 2013 – Apr. 2014 Limited assignment as Specialist, Aseptic Operations, Rentschler Biotechnologie GmbH - Improved batch loss rate by investigating and coordinating Deviations and driving corrective and preventive actions via Change Controls in the area of Filling, Lyophilisation and Crimping incl. presentations Quality Review Board Jan. 2011 - Apr. 2013 Process Engineer, Downstream Processing (DSP) mid scale, Rentschler Biotechnologie GmbH - Ensured customer clinical supply by leading a team to perform downstream processing operations and coordinating related activities