Location: Slovenia, Spain, Turkey, Poland, India #LI-Hybrid
As a Global Technical Steward Biologics andCell therapies you will act as a key Subject Matter Expert in supporting the Novartis sites producing Biologics and Cell therapies as well as the Large Molecules Cell&Gene therapies platform leadership. Your contributions will include among others support to creation of development strategies, selection and introduction of new technologies, manufacturing process improvements, adaptations to new legislations, standardization efforts, benchmarking best practices, increasing site competencies and resolving complex process issues in collaboration with other experts on and above site.
You will report to the Global Head Manufacturing Science and Technology Large molecules CGT Platform.
Key Responsibilities:
• Own the knowledge of specific pharmaceutical manufacturing process technologies at platform level – focus on drug substance manufacturing and Cell therapy manufacturing.
• Act as the platform SME / SPOC for key topics at the interface with global Engineering, Technical Development and other organizations.
• Benchmarking new technologies and equipment relevant for platform. Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements. Provide technical expertise to Engineering for design activities in CAPEX projects around technologies.
• Assure that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.
• Author and implement GOPs for technology assigned.
• Participate in due diligence team evaluations, where applicable, for in-license projects.
• Strive to harmonize and optimize technical processes across the platform.
• Support sites in trouble shooting / root cause investigation by providing second level of specialist expertise as SME and by harmonizing and optimising related technical processes across the units.
• Set standards to perform technical feasibility trials related to process improvement and implementation of new manufacturing technologies.
• Maintain the work at a global level at inspection readiness level and provide the necessary support in any internal or external audit in addition to providing input to and review of regulatory documentation.