Represent the technical interface to our external partners to ensure robust and reliable manufacturing processes running at the CMO sites
Act as the process expert for the assigned projects (USP / DSP; mammalians / microbials)
Lead process validation activities at CMO site together with our partners
Lead implementation of continued process verification (CPV) / monitoring program at CMO site
May participate in supplier evaluation and selection process (Technical Due Diligence)
In case of a commercial project, act as Process Transfer Lead to selected CMO site
Assess impact of technical changes, technical feasibility and scope / design of technical batches
Lead or support root cause investigation of product and process deviations
Lead process improvements (either yield and / or product quality) together with the CMOs
Represent the interface to Novartis internal stakeholders and ensure that new products and processes are well developed for commercial scale and entire product life cycle
Contribute to the registration strategy and ensure alignment of (regulatory) timelines
Education : Academic Degree in Biochemistry, -technology, Molecular Biology, Genetics or equivalent
Languages : fluent in English, German desirable
Experience : minimum of 5 years in biopharmaceutical cGMP manufacturing, in-depth understanding of biotechnology processes (USP & DSP;
mammalian and / or microbial) - mandatory. Demonstrated leadership in a matrix environment, highly self-organized person with strong problem solving skills, high level of pragmatism, collaboration and solution driven mindset.
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group.
The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 62.287,12 per year).
Contact : Cornelia Walch, Senior Staffing Manager