Position Brand Description:
Has overall accountability for and provides oversight to all aspects of vaccine operations at Elanco Cuxhaven Site (Cuxhaven, Germany) including safety, productivity, and quality. This position also directs annual business planning and participates in strategic planning for the site.
The incumbent for this position must have in depth and demonstrable technical and business knowledge of all aspects of vaccine operations (Biotech manufacturing including all aspects of Viral/Bacterial live product manufacturing ) in order to successfully ensure that the site carries out its mission as part of Elanco manufacturing operations worldwide. Critical areas include, but are not limited to, egg based and tissue culture antigen production, formulation, liquid filling, lyophilization, packaging, warehousing, supply chain (cold chain), regulatory compliance and animal services. The incumbent should also have a basic understanding of vaccine research and development and be able to link local and global vaccine R&D services to Cuxhaven vaccine operations as appropriate.
Specific responsibilities and tasks include:
Provide to the site a clear strategy with strong alignment with Elanco vaccine manufacturing and quality strategy.
Accountability for overall Cuxhaven site performance including safety, quality, and customer supply. (might include this rather than bullet below)
Provide oversight to all aspects of operations at Cuxhaven site to ensure scheduled supply of high quality products meeting customer needs.
Provide strong leadership on Operation Excellence Lean efforts across manufacturing and all site functions.
Establishment and maintenance of management processes and systems to ensure adherence to Elanco quality systems, safety, and environmental practices as well as EU-GMP regulations; is accountable for overall regulatory compliance at the site. Understands regulatory and corporate governing body requirements and ensures implementation at site level.
Participate with R&D to ensure any transfers of manufacturing processes for all target antigens and finished products, including assays, are robust during the product transfer to the site.
Ensure effective implementation of quality systems and drive for continuous improvement of overall site performance as demonstrated with key performance indicators and site metrics.
Ensure that manufacturing processes are in control, capable and compliant with regulations and Elanco/Lilly systems.
Ensure that site business performance meets or exceeds financial commitments. Provide oversight of site operational expenses and keep cost of product sold (COPS) aligned with yearly targets or lower than planned. Keep personnel and head count commitments within operations and the support functions.
Strong focus on customer service, delivering the supply chain at or above expectation as agreed for the yearly plan, including On Time and In Full (OTIF) commitment.
Ensure that the site effectively implements and uses Lean Six Sigma tools as part of the continuous improvement culture. Keep track on value capture and cost avoidance projects.
Assure effective implementation of quality, safety, environmental, and business plans. Ensure appropriate resource allocation, capacity and prioritization across the site.
Assure qualified resources with appropriate education, experience and training are hired and in place to execute the roles and responsibilities of site operations.
Oversees expense and capital planning budgets for Cuxhaven.
Drive effective succession planning processes for key technical and management leader positions. Drive development of the site’s technical, management and leadership skills through the application of HR processes.
Responsible for the notification and representation of business and compliance issues to senior management in a timely manner.
Represent Elanco in the community through site efforts.
Maintenance of strong ties across the Elanco Manufacturing Network with the goal of implementing consistent business/quality processes around the world.
Benchmarking and implementation of best practices.
Ensure Health, Safety, and Environmental compliance.
Achieve financial expense and production volume targets.
Responsible for site Business Planning, Long Range Planning, Business Continuity Plans, Business Development.