Heidelberg, Baden-Württemberg, Germany
• Process-oriented operations leader with proven success leading production, MSAT, and global project teams • Key strengths in management of complex tasks and cross-functional coordination in a pharmaceutical manufacturing environment • Broad experience in all phases of pharmaceutical manufacturing, DS and DP, biotech, in-house and with external partners, from development through launch to commercial supply • Extensive international experience and strong communication and language skills
Leadership for prepation and commercial scale manufacture of biological drug substances in cooperation with other site functions. Oversight of production-related TechTransfer activities for multiple products. Staffing, coaching, personnel, and team development. Leading implementation and optimization of ways of working to support consistent, robust commercial operations. Member of site leadership team.
Leadership for all activities in Production, MS&T, Engineering, and Supply Chain to build up the team, implement processes, and start up a new Biotech DS manufacturing facility, including licensing, validation, and commercial supply.
Lead for all activities in production to build up the team, processes, and take a new bulk biotech DS manufacturing facility into commercial operation.
Lead for all activities to design, build, and run a new bulk vaccines facility (160 Mio € investment) meeting budget, timelines, scope, safety and quality requirements; member of site leadership team • Build up and manage a team of (currently) ca. 60 direct and indirect reports to meet project and future commercial needs • Plan, coordinate, and drive all design, construction, and process transfer activities • Liaise with all stakeholders and authorities to ensure alignment and fulfillment of all guidelines • Monitor and report on project status and escalate issues as appropriate to senior management and global committees • Successfully led project through conceptual, basic, and detailed design phases • Secured permitting and completed shell construction according to timelines and budget • Initiated process transfer activities for materials, media, QC, and manufacturing process
Department Head and member of site leadership team • Integrated validation/qualification and production support departments to form MSAT • Led a team of approx. 50 direct and indirect reports, managed objective setting, personnel development, and coaching • Owned all production support, CPV, qualification, process and cleaning validation activities and on site for bulk antigens, formulations, excipients, media and buffers • Ensured coordination with site and global functions as well as external partners • Successfully supported all inspections
Department Head responsible for all qualification, process and cleaning validation activities and related processes on site, member of site leadership team • Managed staff of ca. 35-40 direct and indirect reports • Successfully supported inspections for all validation and qualification topics • Implemented subject matter experts for all key processes • Remediated validation packages for all products • Improved communication and coordination with key partners • Developed staff skill set through SME seminars and project management forum • Drove performance with focus on first time right validations and >95% on time completion of scheduled activities
Lead for upgrade of a launch facility (26.5 Mio USD investment) and taking it into commercial operation • Recruited and managed initial staff of ca. 10 direct reports • Set-up all systems, SOP’s, and logistic processes for GMP manufacture • Ensured know-how transfer manufacturing staff • Planned and executed PQ´s for manufacture, sterilization, and cleaning processes • Managed licensing process with authorities
Global lead for managing all activities in Pharmaceutical Operations and with external partners during handover, validation, submission, and drug product launch • Managed a portfolio of ca. 10 projects, 1/3 to 1/2 late phase (prevalidation - launch) • Led international project teams of ca. 10-40 project reports, coordinated activities across development, manufacturing, supply chain, and business functions • Successfully supported all preparatory and pre-approval inspections • Successfully led launch of: • Xolair (Lyo), Lucentis (Liq in vial), and Ilaris (Lyo) in Novartis Stein • Xolair (Liq in prefilled syringes) at contract manufacturer in DE • Tobi Podhaler at external partners