Product Steward/Biotechnology Drug Substance (w/m)
Area of Responsibility
Product Steward/Biotechnology Drug Substance (w/m), Schaftenau, Austria
Your responsibilities include, but not limited to:
• 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 conduction regular product specific data trending
• Issue data trending report (e.g. ongoing process verification OPV) and present process performance and status of product improvement projects in site Manufacturing Robustness Review Board.
• Triggers and leads (or supports) process capability improvements, promote process and technology improvements (quality, efficiency), identify and address recurring deviations
• Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s).
• Responsible for ensuring the continued state of validation
• Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed
What you’ll bring to the role:
• Academic degree (MSc) in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Technology or equivalent.
• Fluent in English, German beneficial
• Minimum 6 years of experience in process support, e.g. Process Expert role on the shop floor of biopharmaceutical manufacturing, scientist in late stage process development and/or QA/QC.
• Proven understanding of biotechnology processes (Cell culture fermentation, Downstream processing).
• Thorough experience in computerized systems and fundamental understanding of applied statistics (MS-office, SAP, Minitab, JMP, etc.).
• 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 Novartis?
817 million. That’s how many lives our products touched in 2018. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
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 € 48,718.04 per year on a full time basis).
We are Novartis. Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.