Product Steward (f/m/d)
Product Steward (f/m/d), MS&T, Kundl, Österreich Austria
14 Years experience with marketed Biosimilars! More than 40 years experience with Biotech production and a growing product portfolio exploiting new key technologies. Join the Manufacturing Science and Technology team as a Product Steward and contribute in pioneering the future of our Biologics.
Your Key Responsibilities:
• Maintain the oversight and knowledge for entire drug substance manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as single point of contact (SPOC)
• Monitor all critical variables and key variables as appropriate using statistical analysis and conduct regular product specific data trending
• Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed
• Track and evaluate product performance, trending, detect issues, implementation of corrective and preventive actions
• Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams
• Contribute to registration strategy and support registration activities
• Design and manage optimization projects
• Provide expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability
• Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s)
What you’ll bring to the role:
• Academic degree (MSc, PhD) in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Technology or equivalent
• Fluent in English, German proficiency desirable
• Relevant/several years of biopharmaceutical manufacturing and/or development process experiences, e.g. as process expert or scientific position in process development
• Proven understanding of biotechnology processes (Microbial fermentation, downstream processing, GMP, regulatory aspects)
• Thorough experience in computerized systems, sound experience of data handling and fundamental understanding of applied statistics (i.e. MS-office, SAP, Minitab, JMP)
• Understanding and oversight of relevant regulatory requirements, e.g. GMPs, ICH Q-guidelines
• Proven track record in leading interdisciplinary teams and project management skills
• Excellent communication skills
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
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 € 51180,50 EUR per year on a full time basis)
Imagine what you could do at Sandoz!
Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network