Technical Transfer Lead (m/f/d) - Drug Substance Kundl, Tyrol, Austria
40 years' experience with Biotech drug substance production and a growing product portfolio expanding also into cell and gene therapy products. Join the Manufacturing Science and Technology team as Technical Transfer Lead and contribute in pioneering the future of our Biologics portfolio.
Your responsibilities include, but are not limited to:
• Provide technical leadership for transfer projects to our recombinant protein plants and nucleic acid facility (NAF) and liaise efficiently with involved functions (e.g. technical development, supply chain, QA, QC, HSE, other sites, etc.)
• Act as single point of contact (SPOC) on site for technical transfer: Lead and manage all activities for assigned projects on site level for product transfers (process, technology, analytics, capacity, etc.)
• Form and lead site project team - set priorities for project and project team meetings, coordinate project team activities, ensure that Novartis guidelines and HSE and GMP guidelines are met
• Establish site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles and propose solutions. Assess and plan site resource needs and get management approval for the overall project costs (e.g. FTEs, batch costs, investments and external costs), strategies, and timelines
• Formulate the transfer strategy and provide input into overall project strategy and plans including timelines
• Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches for transfer
• Initiate local change control in system on site and ensure approval and closure
• Ensure timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report)
• Establishes local procedures & templates for technical transfer and contribute to process improvement and optimization for product transfers
What you'll bring to the role:
• Academic degree (MSc) in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Technology or equivalent. Ph.D. preferred in life science
• Minimum 8 years of relevant experience in Manufacturing / Manufacturing Science and Technology / Technical development
• Proven understanding of biotechnology processes (Up- and Downstream) and experience in executing process transfers
• 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
• Fluent in English, German beneficial
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. 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 EUR 62146.14 per year on a full time basis)
Imagine what you could do at Novartis!
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Commitment to Diversity & Inclusion:
Novartis 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 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
Ihre Aufgaben: Bearbeiten Sie strukturiert und mit großer Einsatzbereitschaft. Unser Angebot Wir bieten abwechslungsreiche und anspruchsvolle Aufgaben in einem engagierten Team mit hervorragendem Arbeitsklima...
Ihre Aufgaben: Sie führen verfahrenstechnische Planungen und Berechnungen für Prozessanlagen durch, Sie erstellen Fließbilder und R&I Schemata und spezifizieren Anlagenequipment, Auf Basis der...
Ihre Aufgaben: Durchführung von Inspektions-, Wartungs- und Instandsetzungsarbeiten, Selbstständiges Beheben von Störungen an besagten Anlagen sowie die Unterstützung bei der Optimierung...