Novartis
Berufsbezeichnung:
Senior Technical Manager MS&T ESO-BIO | Drug Product (d/f/m)
Unternehmen
Novartis
Stellenbeschreibung
Job Description Summary As a Technical Manager MS&T you are the interface between Country Manufacturing Organizations and Sandoz for technical matters.Job DescriptionSandoz 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!Your key responsibilities (not limited to):Maintaining oversight of processes and technical changes for the assigned product in a specific contract manufacturing organization (from bulk manufacturing to device assembly) ) for legacy and development products.Maintaining the knowledge and the history of the products throughout the commercial lifecycle, since transfer from development to the present momentLeads technical transfers from process perspective, controlling and ensuring the maintenance of technical documentation, e.g. tech transfer documentation and Quality Risk Analysis and liaises efficiently with involved functionsLiaises with various functions internal and external, acting as a representative of MS&T within the relevant supplier relationship teams. Closely cooperating with ESO functions (Quality Assurance, LCM, SCM, etc.), and establishing relations with CMOs with special focus to ensure and improve product process capability, to keep up to date the knowledge of the process and to maintain the product in a constant state of validationTracking the parameters for continuous process verification received from CMOs. Monitors all critical variables and key variables as required for the assigned products (critical process parameters, in-process control parameters, quality attributes, characteristics of raw materials, etc.) by means of statistical analysis and by performing regular data trending for specific productsUnderstanding and management of data trending and statistical analysis for the following purposesDeepening and broadening process understanding and knowledgeDetecting issues related to process capability, e.g. systematic quality defectsWhat you’ll bring to the role:At least a university degree in pharmacy, chemistry or other natural/technical science degreeFluent in English (spoken & written)A minimum of 10 years of relevant working experience in aseptic drug product manufacturing (product presentations/ technologies, aseptic processing and microbial reduction techniques, sterile manufacturing equipment)Demonstrated technical expertise in manufacturing process science and drug developmentExperience in Project & Stakeholder ManagementCommitment to travelPossible job locations are despite the preferred location Kundl (Austria) also Ljubljana (Slovenia) and Barcelona (Spain).Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!The future is ours to shape!Imagine what you could do here at Sandoz!Austria: In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 73.112,90/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.Commitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here:#SandozSkills Desired Applied Statistics, Applied Statistics, Assembly Language (ASM), Back-End Development, Biotechnology, Chemical Engineering, Chemistry, Design Development, Electronic Components, General Hse Knowledge , Incentive Program, Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Leadership, Manufacturing Processes, Manufacturing Production, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Product Development, R&D (Research And Development), Root Cause Analysis (RCA), Software Development, Software Engineering {+ 1 more}
Erwartetes Gehalt
Standort
Kundl, Tirol
Jobdatum
Sat, 19 Oct 2024 01:08:32 GMT
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