Job
Description
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our new Sandoz! Is responsible at global (Divisional) level to define the procedures and processes for successful implementation of product technical transfers either from development to production or between production sites including ESO. Collaborate with sites and CMO s to provide direction and support to ensure the robustness of technical aspects of technology transfers by implementing QbD principles. Job Description Your Key Responsibilities: Your responsibilities include, but not limited to: Establish the global (Divisional) requirements of a technical transfer protocol of relevant information related to materials, analytical methods, premises and equipment, process flow and steps, packaging, HSE, cleaning validation addressing the following technical aspects: o Manufacturing Process Transfer Documentation o Process flow diagrams, IPC tests, process parameters and ranges o Technical, clinical and regulatory batches at site. o Monitoring and continued process verification. o Defining hand-over criteria e.g. number of batches, process capability (Cpk), etc. o Concurrence to all current applicable standards (cGMP, HSE, Regulatory etc.). Establish and manage system to provide the above technical aspects during transfer between sites. Provide technical expertise, as required, with Process Support Leads, Technical Stewards, Product Stewards, Validation Lead during manufacturing of transfer trials or batches. Support continuous process and quality improvements through the development and management of global technology transfer metrics. Provide periodic reporting to Development, Divisional Tech Ops and Quality Assurance leadership on technical transfer activities and performance. Support local sites, as needed, during Compliance audits, when technical transfer activities are evaluated. Develop and manage systems to ensure that lessons learned during the transfer of technology on a site level are applied globally. Work with the local sites and Development to establish performance objectives related to technical transfer activities. What you ll bring to the role: Minimum Requirements: Educational Background: Masters in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent technical / scientific degree. Languages: Fluent in English Experience: Minimum 10 - 15 years experience in pharmaceutical manufacturing, of which 5+ in a product transfer or project management position and 2+ years mid to high level management experience. Comprehensive know-how in pharmaceutical technology Proven process understanding (Pharma, GMP, Regulatory aspects). Sound experience of data handling and applied statistics. Demonstrated leadership and accomplishments in a global/matrix environment in the pharmaceutical industry Demonstrated interpersonal, communication, negotiation and problem solving skills
